Bupropion and naltrexone for smoking cessation: A double-blind randomized placebo-controlled clinical trial

Marc E Mooney, J. M. Schmitz, Sharon S Allen, John Grabowski, Paul R Pentel, A. Oliver, Dorothy K Hatsukami

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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.

Original languageEnglish (US)
Pages (from-to)344-352
Number of pages9
JournalClinical pharmacology and therapeutics
DOIs
StatePublished - Oct 1 2016

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Bupropion
Naltrexone
Smoking Cessation
Randomized Controlled Trials
Placebos
Cotinine
Carbon Monoxide
Nicotine
Saliva
Tobacco Products
Therapeutics

Cite this

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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.",
author = "Mooney, {Marc E} and Schmitz, {J. M.} and Allen, {Sharon S} and John Grabowski and Pentel, {Paul R} and A. Oliver and Hatsukami, {Dorothy K}",
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T1 - Bupropion and naltrexone for smoking cessation

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AU - Mooney, Marc E

AU - Schmitz, J. M.

AU - Allen, Sharon S

AU - Grabowski, John

AU - Pentel, Paul R

AU - Oliver, A.

AU - Hatsukami, Dorothy K

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N2 - 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.

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