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

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

doi:10.1016/j.drugalcdep.2007.05.028

« Previous Next »Drug and Alcohol Dependence
Volume 91, Issue 2 , Pages 141-148, 1 December 2007

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

Theresa Winhusen
- Department of Psychiatry, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH 45267, USA
- Cincinnati Addictions Research Center (CinARC), 3210 Jefferson Avenue, Cincinnati, OH 45220, USA
- Corresponding author at: University of Cincinnati, 3210 Jefferson Avenue, Cincinnati, OH 45220, USA.
Eugene Somoza
- Department of Psychiatry, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH 45267, USA
- Cincinnati Addictions Research Center (CinARC), 3210 Jefferson Avenue, Cincinnati, OH 45220, USA
- Veterans Affairs Medical Center (VISN 10), 3200 Vine Street, Cincinnati, OH 45220, USA
Domenic A. Ciraulo
- Department of Psychiatry, Boston Medical Center and Boston University School of Medicine, 720 Harrison Ave, Boston, MA 02118, USA
Judy M. Harrer
- Department of Psychiatry, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH 45267, USA
- Veterans Affairs Medical Center (VISN 10), 3200 Vine Street, Cincinnati, OH 45220, USA
R. Jeffrey Goldsmith
- Department of Psychiatry, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH 45267, USA
- Veterans Affairs Medical Center (VISN 10), 3200 Vine Street, Cincinnati, OH 45220, USA
John Grabowski
- Substance Abuse Research Center, Department of Psychiatry and Behavioural Sciences, University of Texas-Health Science Center at Houston, 1300 Moursund Street, Houston, TX 77030, USA
Florence S. Coleman
- Mental Health (116); Dayton VA Medical Center, 4100 West Third Street, Dayton, OH 45428, USA
Gordon Mindrum
- Cincinnati Addictions Research Center (CinARC), 3210 Jefferson Avenue, Cincinnati, OH 45220, USA
Roberta Kahn
- National Institute on Drug Abuse, Division of Treatment Research and Development, 6001 Executive Blvd, Rm 4123, Bethesda, MD 20892, USA
Sabuhi Osman
- Cincinnati Addictions Research Center (CinARC), 3210 Jefferson Avenue, Cincinnati, OH 45220, USA
Juris Mezinskis
- Department of Psychiatry, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH 45267, USA
- Veterans Affairs Medical Center (VISN 10), 3200 Vine Street, Cincinnati, OH 45220, USA
Shou-Hua Li
- National Institute on Drug Abuse, Division of Treatment Research and Development, 6001 Executive Blvd, Rm 4123, Bethesda, MD 20892, USA
Daniel Lewis
- Cincinnati Addictions Research Center (CinARC), 3210 Jefferson Avenue, Cincinnati, OH 45220, USA
Paul Horn
- Cincinnati Addictions Research Center (CinARC), 3210 Jefferson Avenue, Cincinnati, OH 45220, USA
- Veterans Affairs Medical Center (VISN 10), 3200 Vine Street, Cincinnati, OH 45220, USA
- Department of Mathematics, University of Cincinnati, 2693 Campus Drive, Cincinnati, OH 45221, USA
Margaret A. Montgomery
- National Institute on Drug Abuse, Division of Treatment Research and Development, 6001 Executive Blvd, Rm 4123, Bethesda, MD 20892, USA
Ahmed Elkashef
- National Institute on Drug Abuse, Division of Treatment Research and Development, 6001 Executive Blvd, Rm 4123, Bethesda, MD 20892, USA

Received 29 March 2007; received in revised form 16 May 2007; accepted 17 May 2007.

Abstract

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 (20mg/day) or matching placebo. All participants received 1h 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.