Phase 3
Completed N=568
Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
TOBACCO USE CESSATION
Source: ClinicalTrials.gov NCT00364156 ↗
Enrolled (actual)
568
Serious AEs
0.2%
Results posted
Nov 2010
Primary outcomePrimary: Biochemically Verified 7-day Point Prevalence Abstinence — 89; 58 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biochemically Verified 7-day Point Prevalence Abstinence |
89; 58 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00364156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.