- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00851357
Telephone Counseling and the Distribution of Nicotine Patches to Smokers
The Efficacy of Telephone Counseling and the Centralized Distribution of Nicotine Replacement Therapy Through a Smoking Cessation Quitline
The primary purpose of this study is to determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to:
- Test if sending active nicotine patches directly will lead to a higher quit rate, compared to a condition where the quitline assists the smokers to obtain patches by other means (e.g. via their health plans).
- Test if sending placebo patches directly will also lead to a higher quit rate.
- Test if quitline counseling increases the quit rate when the smokers already receive the nicotine patches.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92111
- University of Californian, San Diego: California Smokers' Helpline
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- >= 18 years old
- Daily smoker
- >=6 cigarettes per day
- Ready to quit within one month
- First time quitline caller
- Valid phone number
- Valid address (no P.O. boxes)
- California resident
- Agree to participate in study and evaluation
- English or Spanish speaking
Exclusion Criteria:
- Uses other form of tobacco
- Use of Zyban or Chantix
- One of the following conditions: Severe allergy to adhesive tape, Arrhythmia, Angina, Heart attack within last year, Stroke within last year, Uncontrolled high blood pressure, Insulin-dependent diabetes, Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active patches and telephone counseling
Proactive Telephone Counseling and 8-weeks of nicotine patches
|
Subjects are randomized into 1 of 3 conditions: active, placebo or usual care.
Usual care subjects are not mailed patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches.
For those mailed patches directly, we will mail 8 weeks of patches.
Dosage depends on the number of cigarettes per day (cpd).
Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches.
Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches.
Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
Other Names:
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group. Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. |
Placebo Comparator: Placebo patches and telephone counseling
Proactive Telephone Counseling and 8-weeks of placebo patches
|
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group. Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling.
Placebo nicotine patch
Other Names:
|
Active Comparator: Telephone counseling
Proactive Telephone Counseling
|
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group. Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. |
Active Comparator: Active patches and materials
8-weeks of nicotine patches and materials
|
Subjects are randomized into 1 of 3 conditions: active, placebo or usual care.
Usual care subjects are not mailed patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches.
For those mailed patches directly, we will mail 8 weeks of patches.
Dosage depends on the number of cigarettes per day (cpd).
Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches.
Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches.
Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
Other Names:
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group. Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day. |
Active Comparator: Placebo patches and materials
8-weeks placebo patches and materials
|
Placebo nicotine patch
Other Names:
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group. Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day. |
Active Comparator: Materials
Self-help materials
|
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group. Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Six-month Continuous Abstinence From Cigarettes
Time Frame: 7 months post enrollment
|
7 months post enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants Quit for 30-days at 2-months Post Enrollment
Time Frame: 2-months post enrollment
|
2-months post enrollment
|
Collaborators and Investigators
Collaborators
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
- CDPH 05-45834
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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