A randomized trial of naltrexone for smoking cessation

Aims. To evaluate the efficacy and safety of orally administered naltrexone , alone or in combination with nicotine parches, as a treatment for cigaret te smoking. Design. Randomized, partially-blinded 2 x 2 factorial trial usi ng naltrexone (active vs, placebo) and nicotine patches (active vs. none). Participants. One hundred cigarette smokers. Intervention. Twelve weeks of either placebo-only, naltrexone-only, placebo with nicotine patches or nalt rexone with nicotine patches. The naltrexone dose was 50 mg taken once dail y, and the nicotine patch dose was 21 mg/24-hour for the first 8 weeks and 14 mg/24-hour for the remaining 4 weeks. Brief behavioral intervention was provided at each visit. Measurements. One-week point-prevalence smoking abs tinence rates confirmed by an expired air carbon monoxide level of 8 parts per million (ppm) or less, daily cigarette smoking and cigarette craving. F indings. At the end of treatment, there was no effect of naltrexone on smok ing abstinence. The smoking abstinence rates were 19% and 22% for the place bo only and naltrexone only treatment groups, respectively, and 48% and 46% for the placebo with nicotine patch and naltrexone with nicotine patch gro ups, respectively. However, the effect of the nicotine patch at this time w as significant (p = 0.006), but not at the 6-month follow-up. No significan t effect of naltrexone was observed on daily cigarette smoking or cigarette craving during the study. Conclusions. The opioid antagonist naltrexone wa s not found to be effective for smoking cessation and had no significant ef fect on daily cigarette consumption or craving. The results of the present study provide no support for the use of naEtrexone, alone or in combination with nicotine patches, as a therapeutic treatment for smoking cessation.