Twenty-four week maintenance treatment of cigarette smoking with nicotine gum, clonidine and naltrexone

This research study investigated the effect of nicotine gum, clonidine, and naltrexone, in the maintenance treatment of cigarette smoking. In a double blind study, 171 nicotine-dependent male subjects who met DSM-IV criteria for nicotine dependence and smoking 10 cigarettes or more per day, were allocated randomly to three equal groups of 57. Subjects received nicotine gum, clonidine, or naltrexone over a 24-week treatment period. The nicotine gum dose was 2 mg every 1 to 2 h for the first 6 weeks, 2 mg every 2 to 4 h for the next 3 weeks, and 2 mg every 4 to 8 h for the remaining 15 weeks. The clonidine dose was 0.4 mg and the naltrexone dose was 50 mg per day. Continuous abstinence rates were recorded weekly for 24 weeks from the quit date. The abstinence rates by treatment groups were 36.8% for the nicotine gum group, 19.3% for the clonidine group, and 5.3% for the naltrexone group,and all between groups differences were significant. These results support the efficacy and safety of nicotine gum and clonidine for smoking relapse prevention among Iranian nicotine-dependent patients, but call in question the utility of naltrexone treatment for smoking relapse prevention. (C) 2003 Elsevier Inc. All rights reserved.