Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

Study Overview
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Brief Summary
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This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.

Detailed Description
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Please see brief summary.

Official Title
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Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

Conditions
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TOBACCO USE CESSATION

Intervention / Treatment
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* Drug: Standard Patch Treatment
* Drug: 24-weeks of nicotine patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females of descent between the ages of 18-65 who smokes at least 10 cigarettes/day and are seeking smoking cessation treatment. Based on the medical history, physical and laboratory examination, premenopausal female subjects must consent to practice an effective form of contraception during study. Following orientation by the research staff, subjects must sign written informed consent for all study procedures. Exclusion Criteria: Women who are pregnant, planning a pregnancy, or lactating. Current medical problems for which TN is contraindicated including allergy to nicotine, uncontrolled hypertension, unstable angina, serious arrhythmia, heart attack or stroke within the past 6 months, liver and/or kidney failure in the last 6-months and current diabetes. Current treatment of cancer or diagnosed with cancer in the past 6 months Current DSM IV substance use disorders (dependence involving alcohol, cocaine, marijuana or stimulants, benzodiazepines). Current use of TN or other forms of NRT. Concomitant medications (e.g., monoamine oxidase inhibitors or benzodiazepines within past 14 days, antipsychotics, endogenous steroids, and antidepressants (including wellbutrin or bupropion).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended Patch Treatment<br>Participants in this treatment arm receive 24 weeks of 21mg nicotine patch in addition to 8 smoking cessation counseling sessions. | Drug: 24-weeks of nicotine patch<br>* 24-weeks of 21mg nicotine patch<br>|
| Active Comparator: Standard Patch Treatment<br>Participants receive 8 weeks of 21mg nicotine patch followed by 16 weeks of placebo patch. | Drug: Standard Patch Treatment<br>* 8-weeks of nicotine patch + 16-weeks of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically Verified 7-day Point Prevalence Abstinence | To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy. | End of Treatment (week 24) |