At a glance
ClinicalIndex Comparison Record- ✓Age 18 and older
- ✓Smoking greater than 10 cigarettes per day for at least 1 year
- ✓At least one prior attempt to stop smoking
- ✓Baseline expired carbon-monoxide level of at least 10 ppm
- ✕Pregnant or nursing women or women attempting to conceive
- ✕Unstable cardiac disease
- ✕History of dermatoses
- ✕Current alcohol or drug dependence (other than nicotine)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Testing the Effectiveness of Low Dose Naltrexone for Smoking Cessation and Minimization of Post-cessation Weight Gain
In Brief
A Phase 2 clinical trial evaluating Naltrexone, Transdermal nicotine replacement, and 1 other intervention for Nicotine Dependence. Completed, enrolled 172 participants across 1 site.
Detailed Summary
Weight gain after quitting smoking is an important barrier to treatment for many smokers. This study will test a drug called naltrexone with weight-concerned smokers to investigate whether or not this drug both improves smoking cessation quit rates and minimizes post quit weight gain.
Study Details
Timeline
Interventions
Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.