A double-blind, placebo-controlled, randomized clinical trial of oral selegiline hydrochloride for smoking cessation in nicotine-dependent cigarette smokers

Weinberger, Andrea H.; Reutenauer, Erin L.; Jatlow, Peter I.; O’Malley, Stephanie S.; Potenza, Marc N.; George, Tony P.

doi:10.1016/j.drugalcdep.2009.10.009

« Previous Next »Drug and Alcohol Dependence
Volume 107, Issue 2 , Pages 188-195, 1 March 2010

A double-blind, placebo-controlled, randomized clinical trial of oral selegiline hydrochloride for smoking cessation in nicotine-dependent cigarette smokers☆

Andrea H. Weinberger
- Program for Research in Smokers with Mental Illness (PRISM), Department of Psychiatry, Yale University School of Medicine, New Haven, CT 06519, USA
- Substance Abuse Center (SAC), Department of Psychiatry, Yale University School of Medicine, New Haven, CT 06519, USA
- Corresponding author at: Department of Psychiatry, Yale University School of Medicine, 34 Park Street, SAC, Room S-211, New Haven, CT 06519, USA. Tel.: +1 203 974 7598; fax: +1 203 974 7366.
Erin L. Reutenauer
- Program for Research in Smokers with Mental Illness (PRISM), Department of Psychiatry, Yale University School of Medicine, New Haven, CT 06519, USA
- Substance Abuse Center (SAC), Department of Psychiatry, Yale University School of Medicine, New Haven, CT 06519, USA
Peter I. Jatlow
- Departments of Laboratory Medicine and Psychiatry, Yale University School of Medicine, New Haven, CT 06519, USA
Stephanie S. O’Malley
- Substance Abuse Center (SAC), Department of Psychiatry, Yale University School of Medicine, New Haven, CT 06519, USA
Marc N. Potenza
- Substance Abuse Center (SAC), Department of Psychiatry, Yale University School of Medicine, New Haven, CT 06519, USA
- Child Study Center, Yale University School of Medicine, New Haven, CT 06519, USA
Tony P. George
- Program for Research in Smokers with Mental Illness (PRISM), Department of Psychiatry, Yale University School of Medicine, New Haven, CT 06519, USA
- Substance Abuse Center (SAC), Department of Psychiatry, Yale University School of Medicine, New Haven, CT 06519, USA
- Division of Addiction Psychiatry, Department of Psychiatry, University of Toronto and Schizophrenia Program, Centre for Addiction and Mental Health (CAMH), Toronto, Ontario, M5T 1R8 Canada

Received 31 July 2009; received in revised form 16 October 2009; accepted 19 October 2009.

Abstract

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 (<10min) 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).