Providing Free Nicotine Patches to Quitline Smokers
Distribution of Voucher vs. Direct Mailing of Nicotine Patches to Quitline Smokers
The California Smokers' Helpline will conduct a 3 X 2 (nicotine patch by counseling condition) randomized trial to test the provision of nicotine patches to help smokers calling a telephone quitline. The study assesses one factor related to nicotine patches with 3 levels: sending patches directly from the Helpline, providing vouchers that can be redeemed for patches, and usual care. A second factor is counseling plus materials versus materials only. This proposed study has the following specific aims:
- To demonstrate that a voucher for free nicotine patches will increase the quit rate for smokers who do not have access to free nicotine replacement therapy (NRT)
- To demonstrate that sending patches directly from a quitline would outperform sending vouchers for free NRT, since the vouchers impose an additional barrier to those who want to quit
- To determine the effect of telephone counseling in the context of nicotine patch distribution and if any interaction effects exist between counseling and patch conditions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Tobacco smoking leads to nicotine dependence and serious health consequences. Telephone counseling has been shown to improve smokers' chances of quitting and is the most accessible of the three evidence-based forms of counseling (individual face-to-face, group, and telephone). It is well established that offering free NRT can attract many more smokers to call a quitline. However, how much the offer of free NRT helps quitline callers quit successfully is less well documented. There is currently no consistent guideline for quitline practice. We want to determine whether two weeks' worth of starter kit nicotine patches is efficacious for smokers who don't have access to free nicotine patches or quitting aids. The study also will provide data regarding the impact of a barrier to obtaining quitting aids by contrasting a direct mailing condition with a voucher condition. Further, the study will help us determine the effect of telephone counseling in the context of nicotine patch distribution and if any interaction effects exist between counseling and patch conditions
The study uses a randomized controlled design. Smokers who call the Helpline during the recruitment phase, who meet eligibility requirements for the trial and give consent will be randomly assigned to one of six groups along two factors (nicotine patch and telephone counseling), as described below.
The 6 randomized groups are as follows: Group 1: Materials, Group 2: Voucher + Materials, Group 3: Patches + Materials, Group 4: Counseling, Group 5: Voucher + Counseling, Group 6: Patches + Counseling
Two months and seven months after their initial contact with the Helpline, all participants will receive two Assessment Interviews by phone. The interview will cover, as appropriate, smoking status, use of nicotine patches and other quitting aids, history of quitting, and satisfaction with services provided. The Assessment Interview lasts from 5-10 minutes.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92111
- University of California, San Diego; California Smokers' Helpline
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years or older
- Current smoker
- First time quitline caller
- Not eligible for nicotine patches through other programs such as MediCal or Los Angeles County which provides free nicotine patches
- English and/or Spanish speaking
- Valid phone number
- Valid address
- CA resident
- Gave consent to participate in study and evaluation
Exclusion Criteria:
- Contraindication(s) to nicotine patches
- Uses a form of tobacco other than cigarettes
- Plans to use Chantix
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Material Group
Subjects will receive self-help materials
|
|
|
ACTIVE_COMPARATOR: Materials plus Voucher
Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches
|
Subjects will receive a voucher for nicotine patches. Subjects randomized into the voucher condition will receive a voucher that can be exchanged for two weeks' worth of free starter kit nicotine patches by calling a dedicated phone number (Quit Boost). The voucher will be mailed the day after the screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date.
Other Names:
|
|
ACTIVE_COMPARATOR: Materials plus Patches
Subjects will receive self-help materials and a 2 week's worth of nicotine patches
|
Subjects will receive nicotine patches directly sent to their home.
Subjects randomized into the patch condition will receive two weeks' worth of free starter kit nicotine patches directly.
The patches will be mailed directly to their home the day after screening intake.
Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches.
Subjects will be encouraged to start using these patches on their quit date.
Other Names:
|
|
ACTIVE_COMPARATOR: Counseling
Subjects will receive up to 5 sessions of telephone counseling
|
Telephone counseling is conducted in the appropriate language (English and Spanish) by veteran counselors at the California Smokers' Helpline.
Subjects will receive free proactive telephone counseling to help them set up quit smoking plans.
The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit.
It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls.
The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling
|
|
ACTIVE_COMPARATOR: Counseling plus Voucher
Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches.
|
Subjects will receive a voucher for nicotine patches. Subjects randomized into the voucher condition will receive a voucher that can be exchanged for two weeks' worth of free starter kit nicotine patches by calling a dedicated phone number (Quit Boost). The voucher will be mailed the day after the screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date.
Other Names:
Telephone counseling is conducted in the appropriate language (English and Spanish) by veteran counselors at the California Smokers' Helpline.
Subjects will receive free proactive telephone counseling to help them set up quit smoking plans.
The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit.
It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls.
The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling
|
|
ACTIVE_COMPARATOR: Counseling plus Patches
Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches.
|
Subjects will receive nicotine patches directly sent to their home.
Subjects randomized into the patch condition will receive two weeks' worth of free starter kit nicotine patches directly.
The patches will be mailed directly to their home the day after screening intake.
Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches.
Subjects will be encouraged to start using these patches on their quit date.
Other Names:
Telephone counseling is conducted in the appropriate language (English and Spanish) by veteran counselors at the California Smokers' Helpline.
Subjects will receive free proactive telephone counseling to help them set up quit smoking plans.
The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit.
It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls.
The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Six Months Prolonged Abstinence
Time Frame: Seven months post enrollment
|
At seven months post enrollment we will conduct a brief telephone survey to assess smoking status.
The information obtained will allow us to determine six month prolonged abstinence rates.
|
Seven months post enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Smokers Making a 24-hour Quit Attempt
Time Frame: Two months post enrollment
|
At the follow up evaluation, subjects will be asked if they have made a quit attempt that lasted at least 24 hours.
|
Two months post enrollment
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Zhu SH, Anderson CM, Tedeschi GJ, Rosbrook B, Johnson CE, Byrd M, Gutierrez-Terrell E. Evidence of real-world effectiveness of a telephone quitline for smokers. N Engl J Med. 2002 Oct 3;347(14):1087-93. doi: 10.1056/NEJMsa020660.
- Anderson CM, Zhu SH. Tobacco quitlines: looking back and looking ahead. Tob Control. 2007 Dec;16 Suppl 1(Suppl 1):i81-6. doi: 10.1136/tc.2007.020701.
- Cummings KM, Fix BV, Celestino P, Hyland A, Mahoney M, Ossip DJ, Bauer U. Does the number of free nicotine patches given to smokers calling a quitline influence quit rates: results from a quasi-experimental study. BMC Public Health. 2010 Apr 7;10:181. doi: 10.1186/1471-2458-10-181.
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 (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P121218
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