A double-blind, placebo-controlled, randomized clinical trial of oral selegiline
hydrochloride for smoking cessation in nicotine-dependent cigarette smokers.
Author(s): Weinberger AH, Reutenauer EL, Jatlow PI, O'Malley SS, Potenza MN, George TP.
Affiliation(s): Program for Research in Smokers with Mental Illness (PRISM), Department of
Psychiatry, Yale University School of Medicine, New Haven, CT 06519, USA.
Publication date & source: 2010, Drug Alcohol Depend. , 107(2-3):188-95
AIM: The primary aim of this study was to determine the safety and efficacy of
the monoamine oxidase-B (MAO-B) inhibitor selegiline hydrochloride (SEL,
l-Deprenyl; Eldepryl) as an aid for smoking cessation in cigarette smokers.
METHODS: One hundred and one nicotine-dependent adult cigarette smokers without
current psychiatric or substance use disorders participated in this 8-week
randomized, double-blind, placebo-controlled trial. Participants received either
SEL (5mg bid, n=51) or placebo (PLO, n=50), in combination with brief (<10 min)
manualized smoking cessation counseling. The main smoking outcome measures were
7-day point prevalence abstinence at end of trial (EOT), 4-week continuous
smoking abstinence at end of trial (CA), and 7-day point prevalence abstinence at
6-month follow-up (6MFU). Abstinence was determined by an absence of
self-reported cigarette smoking and biochemically verified by expired breath
carbon monoxide and plasma cotinine levels.
RESULTS: Rates of smoking abstinence did not differ by medication group (EOT:
SEL=16%, PLO=20%, p=0.57; CA: SEL=14%, PLO=18%, p=0.56; 6MFU: SEL=12%, PLO=16%,
p=0.54). Adverse events were modest and comparable between medication groups.
Participants receiving SEL were more likely than those receiving PLO to report
dry mouth (25.5% versus 8.2%, p<0.05).
CONCLUSIONS: Our results suggest that SEL was safe and well-tolerated by adult
cigarette smokers, but did not improve smoking abstinence rates compared to PLO.
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