Targeted Interventions for Weight-Concerned Smokers

Phase 2 Completed 172 enrolled Yale University National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2005-01
Primary completion: 2009-04
Completion: 2009-10

Outcome

Missed primary endpoint

paper naltrexone: 6.8 lbs ± 8.94 vs placebo: 9.7 lbs ± 9.19, p = 0.45) was not statistically different. PMID 20542391 ↗

paper Seven-day point-prevalence smoking abstinence rates at 26 weeks post-quit was not significantly different between the 2 groups (naltrexone: 22% vs placebo: 27%, p = 0.43). PMID 20542391 ↗

Publications

Results Toll BA, White M, Wu R, Meandzija B, Jatlow P, Makuch R, O'Malley SS. Low-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: a randomized trial. Drug Alcohol Depend. 2010 Oct 1;111(3):200-6. doi: 10.1016/j.drugalcdep.2010.04.015. Epub 2010 Jun 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naltrexone	Small molecule	25 mg	Oral
Background	Nicotine	Unknown	21 mg	Other