An open-label study of naltrexone and bupropion combination therapy for smoking cessation in overweight and obese subjects.
A combination of sustained release (SR) naltrexone (32 mg/day) and bupropion SR (360 mg/day) plus behavioral counseling was evaluated for the treatment of smoking cessation and mitigation of nicotine withdrawal and weight gain. Thirty overweight or obese nicotine-dependent subjects were enrolled in a 24-week, open-label study; 85% and 63% completed 12 and 2 4weeks, respectively. The target quit date was Week 4. Week 4-12 continuous abstinence rate was 48%, 78% of subjects achieved CO < or = 10 ppm, serum cotinine decreased from 185 to 48 microg/L, and tobacco use decreased from 129 to 14 cigarettes/week. Similar results were seen at Week 24. Body weight was essentially unchanged (Week 12: -0.1%; Week 24: +0.4%). Except for a transient significant increase 1 week after the target quit date (p<0.05), nicotine withdrawal scores did not change. The most common adverse events were nausea, insomnia, and constipation. These tended to be transient and mild or moderate in severity. In overweight or obese smokers, naltrexone/bupropion combination therapy with behavioral counseling was associated with decreased nicotine use, limited nicotine withdrawal symptoms, and no significant weight gain.
Wilcox
Charles S
CS
Pharmacology Research Institute, Los Alamitos, CA, USA. cwilcox@priresearch.com
Oskooilar
Nader
N
Erickson
Janelle S
JS
Billes
Sonja K
SK
Katz
Barbara B
BB
Tollefson
Gary
G
Dunayevich
Eduardo
E
D000328:Adult; D016642:Bupropion / Q000627:therapeutic use*; D003367:Cotinine / Q000097:blood; D003376:Counseling; D018765:Dopamine Uptake Inhibitors / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D009271:Naltrexone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D009765:Obesity / Q000150:complications; D050177:Overweight / Q000150:complications; D012907:Smoking / Q000628:therapy; D016540:Smoking Cessation / Q000379:methods*; D013375:Substance Withdrawal Syndrome / Q000517:prevention & control; D016896:Treatment Outcome; D015430:Weight Gain / Q000187:drug effects*
D018765:Dopamine Uptake Inhibitors; D009292:Narcotic Antagonists; D016642:Bupropion; D009271:Naltrexone; D003367:Cotinine