L S Covey1, A H Glassman, F Stetner. 1. New York State Psychiatric Institute, Department of Psychiatry, College of Physicians and Surgeons, Columbia University 10032, USA.
Abstract
OBJECTIVES: This study examined the efficacy of naltrexone, a long-acting opiate antagonist, as a smoking cessation aid in a double-blind placebo-controlled randomized trial. It was hypothesized that naltrexone would result in higher quit rates at the end of treatment and six months later. METHODS:Subjects were 68 smokers aged 18 to 65 who smoked at least 20 cigarettes daily and wished to stop smoking. They took naltrexone or placebo daily for four weeks and were seen weekly for individual smoking cessation therapy. RESULTS: A statistical trend towards a higher overall cessation rate (cotinine < 15 ng/mL) at end-of-treatment was observed among subjects treated with naltrexone than placebo (46.7% vs. 26.3%, respectively, odds ratio = 2.5, p < .10); however, this difference was attenuated at six months (27% vs. 15%, respectively, odds ratio = 1.9, p = ns). Stratified analysis indicated the usefulness of naltrexone primarily for female smokers and those with a history of major depression. These effects remained six months later. CONCLUSION: These results provide, at best, mild promise for naltrexone as a smoking cessation drug and provide another instance of a differential response to nicotine dependence treatment according to gender and depression history.
RCT Entities:
OBJECTIVES: This study examined the efficacy of naltrexone, a long-acting opiate antagonist, as a smoking cessation aid in a double-blind placebo-controlled randomized trial. It was hypothesized that naltrexone would result in higher quit rates at the end of treatment and six months later. METHODS: Subjects were 68 smokers aged 18 to 65 who smoked at least 20 cigarettes daily and wished to stop smoking. They took naltrexone or placebo daily for four weeks and were seen weekly for individual smoking cessation therapy. RESULTS: A statistical trend towards a higher overall cessation rate (cotinine < 15 ng/mL) at end-of-treatment was observed among subjects treated with naltrexone than placebo (46.7% vs. 26.3%, respectively, odds ratio = 2.5, p < .10); however, this difference was attenuated at six months (27% vs. 15%, respectively, odds ratio = 1.9, p = ns). Stratified analysis indicated the usefulness of naltrexone primarily for female smokers and those with a history of major depression. These effects remained six months later. CONCLUSION: These results provide, at best, mild promise for naltrexone as a smoking cessation drug and provide another instance of a differential response to nicotine dependence treatment according to gender and depression history.
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