Naltrexone augments the effects of nicotine replacement therapy in female smokers

BACKGROUND: There is increased recognition that gender differences may influence outcomes and may modify vulnerability to tobacco addiction, severity of course and response to different treatments. We hypothesized that naltrexone, which has been used to successfully treat opioid and alcohol dependence, when combined with nicotine replacement therapy (NRT) and psychosocial therapy (PT) may enhance smoking cessation rates in women. METHODS: Forty-four adult female smokers meeting DSM-IV criteria for nicotine dependence with expired carbon monoxide content of > or = 15 ppm were randomly assigned in a double blind placebo controlled clinical trial of naltrexone 50 mg + NRT patch + psychosocial therapy (N + NRT + PT)(N = 12) or placebo + NRT patch + psychosocial therapy (P + N + PT)(N=12) for 12 weeks. RESULTS: Twelve weeks of treatment was completed by 54.5%. Smoking cessation among females who completed the 12 weeks for N + NRT + PT was 91.7% (11/12) and for P + NRT + PT was 50% (6/12). CONCLUSION: Naltrexone combined with NRT and psychosocial therapy appears to have a positive cessation effect on women and may be a new treatment option for recidivist female smokers.