A double-blind, placebo-controlled trial of tiagabine for the treatment of cocaine dependence

Theresa Winhusen, Eugene Somoza, Domenic A. Ciraulo, Judy M. Harrer, R. Jeffrey Goldsmith, John Grabowski, Florence S. Coleman, Gordon Mindrum, Roberta Kahn, Sabuhi Osman, Juris Mezinskis, Shou Hua Li, Daniel Lewis, Paul Horn, Margaret A. Montgomery, Ahmed Elkashef

Research output: Contribution to journalArticlepeer-review

44 Scopus citations


Background: The potential efficacy of tiagabine for treating cocaine dependence is suggested by both pre-clinical research and two small clinical trials. Method: 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 1 h 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. Conclusion: These results suggest that tiagabine, at a dose of 20 mg/day, did not have a robust effect in decreasing cocaine use.

Original languageEnglish (US)
Pages (from-to)141-148
Number of pages8
JournalDrug and alcohol dependence
Issue number2-3
StatePublished - Dec 1 2007
Externally publishedYes

Bibliographical note

Funding Information:
This study was supported by the National Institutes of Health, National Institute on Drug Abuse through contract N01-DA-9-8095 (E. Somoza). The study medication and matching placebo were provided by Cephalon at no cost. Dr. Ciraulo has served as a consultant for Alkermes, Astra Zeneca, Bristol Myers Squibb, Cephalon, Johnson & Johnson, Ortho-McNeil, and UCB Pharma. We thank the faculty and staff at the study sites for their contributions to this project. In particular we wish to thank Jacqueline Carter, B.S., Cindy Schulze, B.A., Rachel Heffield, B.A., Daniel Owens, L.S.W., Ron Coleman, B.A., Eva Moore, Julie Jansen, B.A., Cathy Otto, M.A., Barbara Thomas, M.A., Daniel Alfaro, M.D. We thank Gerardo González, M.D. for his assistance in reproducing his primary analysis with our study data.


  • Clinical trial
  • Cocaine dependence
  • Double-blind
  • Tiagabine


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