title: Bupropion and naltrexone for smoking cessation: A double-blind randomized placebo-controlled clinical trial.
abstract: Combination of non-nicotine pharmacotherapies has been underexamined for cigarette smoking cessation. A randomized, double-blind, parallel-group double-dummy study evaluated two medications, bupropion (BUP) and naltrexone (NTX), in treatment-seeking cigarette smokers (N = 121) over a 7-week treatment intervention with 6-month follow-up. Smokers were randomized to either BUP (300 mg/day) + placebo (PBO) or BUP (300 mg/day) + NTX (50 mg/day). The primary outcome was biochemically verified (saliva cotinine, carbon monoxide) 7-day, point-prevalence abstinence. BUP + NTX was associated with significantly higher point-prevalence abstinence rates after 7-weeks of treatment (BUP + NTX, 54.1%; BUP + PBO, 33.3%), P = 0.0210, but not at 6-month follow-up (BUP + NTX, 27.9%; BUP + PBO, 15.0%), P = 0.09. Continuous abstinence rates did not differ, P = 0.0740 (BUP + NTX, 26.2%; BUP + PBO, 13.3%). Those receiving BUP + NTX reported reduced nicotine withdrawal, P = 0.0364. The BUP + NTX combination was associated with elevated rates of some side effects, but with no significant difference in retention between the groups.
authors.affiliation: Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA. moon0078@umn.edu.
authors.forename: M E
authors.initials: ME
authors.lastname: Mooney
authors.affiliation: Department of Psychiatry and Behavioral Sciences, University of Texas, Houston, Houston, Texas, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Schmitz
authors.affiliation: Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: S
authors.initials: S
authors.lastname: Allen
authors.affiliation: Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: J
authors.initials: J
authors.lastname: Grabowski
authors.affiliation: Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: P
authors.initials: P
authors.lastname: Pentel
authors.affiliation: Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: A
authors.initials: A
authors.lastname: Oliver
authors.affiliation: Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: D K
authors.initials: DK
authors.lastname: Hatsukami
mesh_terms: D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use; D016642:Bupropion / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D009271:Naltrexone / Q000009:adverse effects / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D010349:Patient Compliance; D012907:Smoking / Q000188:drug therapy*; D016540:Smoking Cessation / Q000379:methods*; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018687:Antidepressive Agents, Second-Generation; D009292:Narcotic Antagonists; D016642:Bupropion; D009271:Naltrexone