Tiagabine increases cocaine-free urines in cocaine-dependent methadone-treated patients: results of a randomized pilot study
Article first published online: 23 OCT 2003
Volume 98, Issue 11, pages 1625–1632, November 2003
How to Cite
Gonzalez, G., Sevarino, K., Sofuoglu, M., Poling, J., Oliveto, A., Gonsai, K., George, T. P. and Kosten, T. R. (2003), Tiagabine increases cocaine-free urines in cocaine-dependent methadone-treated patients: results of a randomized pilot study. Addiction, 98: 1625–1632. doi: 10.1046/j.1360-0443.2003.00544.x
- Issue published online: 23 OCT 2003
- Article first published online: 23 OCT 2003
- Submitted 9 December 2002; initial review completed 14 February 2003; final version accepted 16 June 2003
- clinical trial
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.