A double-blind, placebo-controlled trial of tiagabine for the treatment of cocaine dependence.
BACKGROUND
The potential efficacy of tiagabine for treating cocaine dependence is suggested by both pre-clinical research and two small clinical trials.


METHODS
One hundred and forty one participants who met DSM-IV criteria for cocaine dependence were enrolled into this 12-week, double blind, placebo controlled outpatient trial. Participants received either tiagabine (20 mg/day) or matching placebo. All participants received 1h of manualized individual cognitive behavioral therapy on a weekly basis. Outcome measures included cocaine use as determined by self-report confirmed with urine benzoylecgonine (BE) results, and qualitative and quantitative urine toxicology measures. Safety measures included adverse events, EKGs, vital signs, and laboratory tests.


RESULTS
Seventy-nine participants (i.e., 56%) completed the 12-week trial. The safety results suggest that tiagabine was safe and generally well tolerated by the participants. Participants in both groups improved significantly on cocaine craving and global functioning, with no significant differences between the groups. There were no significant changes in cocaine use as measured by self-report confirmed by urine BE or by quantitative urine toxicology results. Qualitative urine toxicology results suggest a possible weak effect for tiagabine in reducing cocaine use.


CONCLUSIONS
These results suggest that tiagabine, at a dose of 20 mg/day, did not have a robust effect in decreasing cocaine use.
Winhusen
Theresa
T
Department of Psychiatry, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH 45267, USA. winhusen@mdru.uc.edu
Somoza
Eugene
E
Ciraulo
Domenic A
DA
Harrer
Judy M
JM
Goldsmith
R Jeffrey
RJ
Grabowski
John
J
Coleman
Florence S
FS
Mindrum
Gordon
G
Kahn
Roberta
R
Osman
Sabuhi
S
Mezinskis
Juris
J
Li
Shou-Hua
SH
Lewis
Daniel
D
Horn
Paul
P
Montgomery
Margaret A
MA
Elkashef
Ahmed
A
D000328:Adult; D000437:Alcoholism / Q000453:epidemiology; D019970:Cocaine-Related Disorders / Q000188:drug therapy* / Q000453:epidemiology; D015897:Comorbidity; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D014179:Neurotransmitter Uptake Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D009557:Nipecotic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D010919:Placebos; D000078308:Tiagabine; D016896:Treatment Outcome
D014179:Neurotransmitter Uptake Inhibitors; D009557:Nipecotic Acids; D010919:Placebos; D000078308:Tiagabine