Tiagabine increases cocaine-free urines in cocaine-dependent methadone-treated patients: results of a randomized pilot study

Addiction. 2003 Nov;98(11):1625-32. doi: 10.1046/j.1360-0443.2003.00544.x.


Aims: We sought to evaluate the safety and efficacy of the GABAergic agent tiagabine in reducing cocaine use among methadone-treated patients.

Design: Ten-week randomized double-blind placebo-controlled trial.

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

Participants: 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).

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

Measures: 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.

Findings: 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, Non-P.H.S.
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Analysis of Variance
  • Cocaine / urine
  • Cocaine-Related Disorders / rehabilitation*
  • Cocaine-Related Disorders / urine
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • GABA Agents / administration & dosage
  • GABA Agents / therapeutic use*
  • Humans
  • Linear Models
  • Male
  • Methadone / therapeutic use*
  • Narcotics / therapeutic use*
  • Nipecotic Acids / administration & dosage
  • Nipecotic Acids / therapeutic use*
  • Pilot Projects
  • Substance Abuse Detection / methods*
  • Tiagabine


  • GABA Agents
  • Narcotics
  • Nipecotic Acids
  • Cocaine
  • Methadone
  • Tiagabine