An open-label study of naltrexone and bupropion combination therapy for smoking cessation in overweight and obese subjects

• Published in: Addictive behaviors Vol. 35; no. 3; pp. 229 - 234
• Main Authors: Wilcox, Charles S., Oskooilar, Nader, Erickson, Janelle S., Billes, Sonja K., Katz, Barbara B., Tollefson, Gary, Dunayevich, Eduardo
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.03.2010; Elsevier Science Ltd
• Subjects: Adult; Bupropion; Bupropion - therapeutic use; Cotinine - blood; Counseling; Dopamine Uptake Inhibitors - therapeutic use; Drug therapy; Drug Therapy, Combination; Female; Humans; Male; Naltrexone; Naltrexone - therapeutic use; Narcotic Antagonists - therapeutic use; Nicotine; Nicotine addiction; Obesity; Obesity - complications; Overweight - complications; Psychiatry; Smoking - therapy; Smoking cessation; Smoking Cessation - methods; Substance Withdrawal Syndrome - prevention & control; Treatment Outcome; Weight; Weight control; Weight Gain - drug effects; NRT; Smoking cessation; Weight control; Bupropion; Naltrexone; Nicotine addiction; BMI; SR; nicotine replacement therapy; sustained release; body mass index
• ISSN: 0306-4603; 1873-6327; 1873-6327
• DOI: 10.1016/j.addbeh.2009.10.017

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 24 weeks, respectively. The target quit date was Week 4. Week 4–12 continuous abstinence rate was 48%, 78% of subjects achieved CO ≤ 10 ppm, serum cotinine decreased from 185 to 48 μg/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.