Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
Status:
Completed
Trial end date:
2008-05-01
Target enrollment:
Participant gender:
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.