Identifying Optimal Smoking Cessation Intervention Components (Cessation) (Cessation)
Project 2: Identifying Optimal Smoking Cessation Intervention Components
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Counseling before quit attempt
- Behavioral: Minimal In-person counseling during quit attempt
- Behavioral: Minimal phone counseling during the quit attempt
- Drug: Short Term Nicotine Patch + Nicotine Gum during the quit attempt
- Drug: Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum
- Behavioral: Intensive phone counseling during the quit attempt
- Drug: Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt
- Behavioral: Intensive in-person counseling during the quit attempt
- Drug: Pre-Quit Nicotine Patch
- Drug: Pre-Quit Nicotine Gum
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53711
- University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age or older;
- Report smoking at least 5 cigarettes per day for the previous 6 months;
- Able to read and write English;
- Agree to attend visits, to respond to coaching calls, and to respond to Interactive Voice Response (IVR) phone prompts;
- Plans to remain in the intervention catchment area for at least 12 months;
- Currently interested in quitting smoking (defined as would like to try to quit in the next 30 days).
- All women of childbearing potential will be required to agree to use an acceptable method of birth control to prevent pregnancy during the study.
Exclusion Criteria:
- Currently taking bupropion, Wellbutrin, chantix or varenicline (current use of NRT is not exclusionary if the participant agrees to use only study medication for the duration of the study);
- Study candidate is pregnant, trying to get pregnant, or nursing.
- A history of psychosis or bipolar disorder
- A history of skin or allergic reactions while using a nicotine patch.
- Had a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: 1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks. If randomized to both the Prequit Patch and Prequit Gum Conditions: Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day. |
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EXPERIMENTAL: 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
If randomized to both the Prequit Patch and Prequit Gum Conditions: Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks. |
|
EXPERIMENTAL: 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to both the Prequit Patch and Prequit Gum Conditions: Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day. If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
|
|
EXPERIMENTAL: 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks. If randomized to both the Prequit Patch and Prequit Gum Conditions: Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
|
|
EXPERIMENTAL: 5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to both the Prequit Patch and Prequit Gum Conditions: Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day. If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks. |
|
EXPERIMENTAL: 6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks. If randomized to both the Prequit Patch and Prequit Gum Conditions: Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
|
|
EXPERIMENTAL: 7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks. If randomized to both the Prequit Patch and Prequit Gum Conditions: Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
|
|
EXPERIMENTAL: 8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
If randomized to both the Prequit Patch and Prequit Gum Conditions: Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day.
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
|
|
EXPERIMENTAL: 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks. If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum): Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day. |
|
EXPERIMENTAL: 10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum): Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day. |
|
EXPERIMENTAL: 11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum): Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day. |
|
EXPERIMENTAL: 12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum): Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day. |
|
EXPERIMENTAL: 13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks. If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum): Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day. |
|
EXPERIMENTAL: 14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks. If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum): Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day. |
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EXPERIMENTAL: 15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum): Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day. |
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EXPERIMENTAL: 16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk
This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum): Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day. |
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EXPERIMENTAL: 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks. If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch): Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day. |
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EXPERIMENTAL: 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch): Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day. |
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EXPERIMENTAL: 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch): Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day. |
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EXPERIMENTAL: 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk
How effective is the following Intervention?
No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
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Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch): Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day. |
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EXPERIMENTAL: 21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks. If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch): Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day. |
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EXPERIMENTAL: 22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks. If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch): Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day. |
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EXPERIMENTAL: 23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch): Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day. |
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EXPERIMENTAL: 24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch): Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day. |
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EXPERIMENTAL: 25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks. |
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EXPERIMENTAL: 26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks. |
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EXPERIMENTAL: 27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
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EXPERIMENTAL: 28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day.
In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts.
Participants will be asked to engage in two practice quit attempts.
These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
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EXPERIMENTAL: 29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks. |
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EXPERIMENTAL: 30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day.
The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date.
(This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
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EXPERIMENTAL: 31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day.
This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support.
Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
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EXPERIMENTAL: 32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16
This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day).
The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations.
The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks.
Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day.
The counseling will include intra-treatment social support and skill-based competence intervention components.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self-Reported 7-Day Point-Prevalence Abstinence
Time Frame: 16 weeks post-quit
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Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (16 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model. Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal "Addiction") advised us to change the primary outcome to the current week 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome. |
16 weeks post-quit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Latency to Relapse
Time Frame: During the first 6 months post-quit
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Latency to Relapse during the first 6 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored.
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During the first 6 months post-quit
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Megan E Piper, PhD, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
- Principal Investigator: Timothy B Baker, PhD, University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- H-2009-0204
- 9P50CA143188 (U.S. NIH Grant/Contract)
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