At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
In Brief
A Phase 3 clinical trial evaluating Standard Patch Treatment and 24-weeks of nicotine patch for TOBACCO USE CESSATION. Completed, enrolled 568 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
8-weeks of nicotine patch + 16-weeks of placebo
24-weeks of 21mg nicotine patch