Efficacy of Naltrexone in Women's Smoking Cessation
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
Summary
The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to
compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard
smoking cessation treatment with nicotine patch and counseling.
Hypotheses:
1. Naltrexone will improve smoking cessation quit rates, as measured at the end of active
treatment (3 months) and during long term follow up (1 year).
2. Weight and smoking-related variables (i.e., less weight gain, as well as reduced craving
and withdrawal) will be important factors by which naltrexone improves smoking cessation
outcome.
3. These effects are predicted to be stronger in women compared to men.
Phase:
Phase 2
Details
Lead Sponsor:
University of Chicago
Collaborators:
National Institute on Drug Abuse (NIDA) National Institutes of Health (NIH)