Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

568 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-05-31

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.

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Detailed Description

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Conditions

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TOBACCO USE CESSATION

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Extended Patch Treatment

Participants in this treatment arm receive 24 weeks of 21mg nicotine patch in addition to 8 smoking cessation counseling sessions.

Group Type EXPERIMENTAL

24-weeks of nicotine patch

Intervention Type DRUG

24-weeks of 21mg nicotine patch

Standard Patch Treatment

Participants receive 8 weeks of 21mg nicotine patch followed by 16 weeks of placebo patch.

Group Type ACTIVE_COMPARATOR

Standard Patch Treatment

Intervention Type DRUG

8-weeks of nicotine patch + 16-weeks of placebo

Interventions

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Standard Patch Treatment

8-weeks of nicotine patch + 16-weeks of placebo

Intervention Type DRUG

24-weeks of nicotine patch

24-weeks of 21mg nicotine patch

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Males and females of descent between the ages of 18-65 who smokes at least 10 cigarettes/day and are seeking smoking cessation treatment.
2. Based on the medical history, physical and laboratory examination, premenopausal female subjects must consent to practice an effective form of contraception during study.
3. Following orientation by the research staff, subjects must sign written informed consent for all study procedures.

Exclusion Criteria

1. Women who are pregnant, planning a pregnancy, or lactating.
2. 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.
3. Current treatment of cancer or diagnosed with cancer in the past 6 months
4. Current DSM IV substance use disorders (dependence involving alcohol, cocaine, marijuana or stimulants, benzodiazepines).
5. Current use of TN or other forms of NRT.
6. Concomitant medications (e.g., monoamine oxidase inhibitors or benzodiazepines within past 14 days, antipsychotics, endogenous steroids, and antidepressants (including wellbutrin or bupropion).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes