Tiagabine increases cocaine-free urines in cocaine-dependent methadone-treated patients: results of a randomized pilot study.
OBJECTIVE
We sought to evaluate the safety and efficacy of the GABAergic agent tiagabine in reducing cocaine use among methadone-treated patients.


METHODS
Ten-week randomized double-blind placebo-controlled trial.


METHODS
Opiate Treatment Research Program, Veteran's Affairs Connecticut Healthcare System in West Haven, Connecticut, USA.


METHODS
The participants were 45 cocaine-dependent methadone-treated patients who were predominately Caucasian (75.6%), male (77.8%) and never married (53%) with an average age of 38 years (SD = 6.5).


METHODS
Comparison groups received tiagabine 12 mg/day (n = 15), tiagabine 24 mg/day (n = 15) or placebo (n = 15).


METHODS
Baseline assessments included the Structured Clinical Interview for DSM-IV, the Addiction Severity Index, a urine drug test, self-reported use and opiate withdrawal scales. Urine drug tests were performed thrice weekly.


RESULTS
Treatment retention was over 80% for all treatment groups. The sample mean (+/- SE) of cocaine-free urines for the first week after study entry and before tiagabine was started was 1.16 (0.19) urines/week. During weeks 9 and 10 cocaine-free urines increased significantly from baseline by 33% with high-dose tiagabine (24 mg/day), by 14% with low-dose tiagabine (12 mg/day) and decreased by 10% with placebo (hierarchical linear model, Z= 2.03; P < 0.05). Self-reported cocaine use also decreased significantly more with active medications than with placebo.


CONCLUSIONS
Tiagabine at 24 mg/day was well tolerated among these methadone-treated patients with only one reporting headache. Tiagabine appears to be a promising GABAergic medication that moderately improves cocaine-free urines.
Gonzalez
Gerardo
G
Department of Psychiatry, Yale University School of Medicine, West Haven, CT, USA. Gerardo.Gonzalez-Haddad@yale.edu
Sevarino
Kevin
K
Sofuoglu
Mehmet
M
Poling
Jim
J
Oliveto
Alison
A
Gonsai
Kishor
K
George
Tony P
TP
Kosten
Thomas R
TR
D000328:Adult; D000704:Analysis of Variance; D003042:Cocaine / Q000652:urine; D019970:Cocaine-Related Disorders / Q000534:rehabilitation* / Q000652:urine; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D018682:GABA Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D016014:Linear Models; D008297:Male; D008691:Methadone / Q000627:therapeutic use*; D009294:Narcotics / Q000627:therapeutic use*; D009557:Nipecotic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D010865:Pilot Projects; D015813:Substance Abuse Detection / Q000379:methods*; D000078308:Tiagabine
D018682:GABA Agents; D009294:Narcotics; D009557:Nipecotic Acids; D003042:Cocaine; D008691:Methadone; D000078308:Tiagabine