An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
The transdermal nicotine patch is the most widely used form of tobacco dependence treatment
in the US and Europe, but most smokers are unable to successfully quit with this form of
treatment. Failure to respond to this treatment may, to a large extent, be due to the use of
nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a
controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase
quit rates significantly. We propose here a clinical trial to replicate and extend these
results to a community setting in the real-world, using the same research design utilized in
clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate
dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks),
extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The
main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness,
safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for
maintenance therapy with transdermal nicotine will also be assessed. The study results may
change how we treat nicotine dependence with transdermal nicotine.