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

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 meth a done-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.