Multi-center trial of baclofen for abstinence initiation in severe cocaine-dependent individuals.
Cocaine dependence is a major public health problem for which there is no FDA-approved pharmacological treatment. Baclofen is a GABA(B) receptor agonist that in preclinical and early pilot clinical trials has shown promise for the treatment of cocaine dependence. The purpose of this multi-site, double-blind study, was to compare the safety and efficacy of baclofen (60 mg/day) vs placebo in an 8-week treatment of individuals with severe cocaine dependence. The primary outcome measure was subjects' self-reported cocaine use substantiated by urine benzoylecgonine (BE). Analysis of the data did not show a significant difference between the groups treated with baclofen and placebo. The current results do not support a role for 60 mg baclofen in treating cocaine dependence in the population studied. The contrast of this result to earlier, preclinical and human pilot data with baclofen may reflect the trial's focus on severe cocaine-dependent users, and/or the need for a higher baclofen dose. Baclofen's potential as a relapse prevention agent was not tested by the current design, but may be a useful target for future studies.
Division of Pharmacotherapies and Medical Consequences of Drug Abuse, National Institute on Drug Abuse, 6001 Executive Blvd., Bethesda, MD 20892, USA.
Roberta
R
Kahn
Kousick
K
Biswas
Anna-Rose
AR
Childress
Steve
S
Shoptaw
Paul J
PJ
Fudala
Liza
L
Gorgon
Ivan
I
Montoya
Joseph
J
Collins
Frances
F
McSherry
Shou-Hua
SH
Li
Nora
N
Chiang
Husam
H
Alathari
Donnie
D
Watson
Joseph
J
Liberto
Thomas
T
Beresford
Christopher
C
Stock
Christopher
C
Wallace
Valerie
V
Gruber
Ahmed
A
Elkashef
D000328:Adult; D001418:Baclofen / Q000627:therapeutic use*; D001521:Behavior Therapy; D003042:Cocaine / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000652:urine; D019970:Cocaine-Related Disorders / Q000188:drug therapy* / Q000534:rehabilitation / Q000652:urine; D003131:Combined Modality Therapy; D003376:Counseling; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004522:Educational Status; D004651:Employment; D005260:Female; D018755:GABA Agonists / Q000627:therapeutic use; D006801:Humans; D008032:Limbic System / Q000187:drug effects / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010919:Placebos; D044469:Racial Groups; D012449:Safety
D018755:GABA Agonists; D010919:Placebos; C005618:benzoylecgonine; D001418:Baclofen; D003042:Cocaine