At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years
- ✓Cigarette smoker of 15–40 cigarettes daily for ≥2 years
- ✓Current DSM-IV Nicotine Dependence confirmed by SCID interview
- ✓Desire to quit smoking (≥7/10 on interest scale)
- ✕Substance dependence in past 1 year (except nicotine) or any lifetime opioid dependence history
- ✕Major psychiatric disorder in past 1 year (Axis I, moderate/severe Axis II, Bipolar, or Psychotic Disorder)
- ✕Past or current significant medical disorders (cardiovascular, hepatic, neurological, endocrine) that may interact with study measures
- ✕Clinically significant lab abnormalities, positive urine toxicology, or positive pregnancy test
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy of Naltrexone in Women's Smoking Cessation
In Brief
A Phase 2 clinical trial evaluating Naltrexone (drug) and Placebo (for Naltrexone) for Smoking and Smoking Cessation. Completed, enrolled 333 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
50 mg q.d. for 13 weeks
Sugar pill manufactured to mimic Naltrexone tablet