A double-blind, placebo-controlled, randomized clinical trial of oral selegiline hydrochloride for smoking cessation in nicotine-dependent cigarette smokers.
OBJECTIVE
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.
Weinberger
Andrea H
AH
Program for Research in Smokers with Mental Illness (PRISM), Department of Psychiatry, Yale University School of Medicine, New Haven, CT 06519, USA.
Reutenauer
Erin L
EL
Jatlow
Peter I
PI
O'Malley
Stephanie S
SS
Potenza
Marc N
MN
George
Tony P
TP
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D002248:Carbon Monoxide / Q000032:analysis; D003367:Cotinine / Q000097:blood; D004244:Dizziness / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D008996:Monoamine Oxidase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D012642:Selegiline / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012907:Smoking / Q000188:drug therapy* / Q000523:psychology; D016540:Smoking Cessation / Q000523:psychology* / Q000706:statistics & numerical data; D014029:Tobacco Use Disorder / Q000150:complications*; D016896:Treatment Outcome; D014987:Xerostomia / Q000139:chemically induced; D055815:Young Adult
D008996:Monoamine Oxidase Inhibitors; D010919:Placebos; D012642:Selegiline; D002248:Carbon Monoxide; D003367:Cotinine