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

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

doi:10.1016/j.drugalcdep.2007.05.021

« Previous Next »Drug and Alcohol Dependence
Volume 91, Issue 2 , Pages 205-212, 1 December 2007

A double-blind, placebo-controlled trial of reserpine 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. Tel.: +1 513 487 7802; fax: +1 513 487 7819.
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
Ofra Sarid-Segal
- Department of Psychiatry, MDRU, VA Boston Healthcare System, Boston University School of Medicine, 720 Harrison Ave, Boston, MA 02118, 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
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
Florence S. Coleman
- Mental Health (116), Dayton VA Medical Center, 4100 West Third Street, Dayton, OH 45428, 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
Maryam Afshar
- Department of Psychiatry, MDRU, VA Boston Healthcare System, Boston University School of Medicine, 720 Harrison Ave, Boston, MA 02118, USA
Domenic A. Ciraulo
- Department of Psychiatry, MDRU, VA Boston Healthcare System, Boston University School of Medicine, 720 Harrison Ave, Boston, MA 02118, 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 15 December 2006; received in revised form 18 May 2007; accepted 27 May 2007.

Abstract

Background

Cocaine's increase of dopamine is strongly associated with its reinforcing properties and, thus, agents that reduce dopamine have received much attention as candidate cocaine-dependence treatments. The potential efficacy of reserpine, a dopamine depletor, for treating cocaine dependence is suggested by both pre-clinical research and a small clinical trial.

Method

One hundred and nineteen participants who met DSM-IV criteria for cocaine dependence were enrolled into this 12-week, double-blind, placebo-controlled outpatient trial. Participants received either reserpine (0.5mg/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 results, cocaine craving, addiction severity index scores, and clinical global impression scores. Safety measures included adverse events, EKGs, vital signs, laboratory tests, and the Hamilton Depression Inventory.

Results

Seventy-nine participants (i.e., 66%) completed the 12-week trial. The safety results suggest that reserpine was safe and well tolerated by the participants. The efficacy measures indicated no significant differences between reserpine and placebo.