Get access

A placebo-controlled screening trial of tiagabine, sertraline and donepezil as cocaine dependence treatments

Authors

  • Theresa M. Winhusen,

    Corresponding author
    1. Cincinnati VA/UC NIDA MDRU, VA Medical Center, Cincinnati, OH,
    2. Cincinnati Addiction Research Center (CinARC), University of Cincinnati College of Medicine, Cincinnati, OH,
    Search for more papers by this author
  • Eugene C. Somoza,

    1. Cincinnati VA/UC NIDA MDRU, VA Medical Center, Cincinnati, OH,
    2. Cincinnati Addiction Research Center (CinARC), University of Cincinnati College of Medicine, Cincinnati, OH,
    Search for more papers by this author
  • Judy M. Harrer,

    1. Cincinnati VA/UC NIDA MDRU, VA Medical Center, Cincinnati, OH,
    2. Cincinnati Addiction Research Center (CinARC), University of Cincinnati College of Medicine, Cincinnati, OH,
    Search for more papers by this author
  • Juris P. Mezinskis,

    1. Cincinnati VA/UC NIDA MDRU, VA Medical Center, Cincinnati, OH,
    2. Cincinnati Addiction Research Center (CinARC), University of Cincinnati College of Medicine, Cincinnati, OH,
    Search for more papers by this author
  • Margaret A. Montgomery,

    1. National Institute on Drug Abuse Medications Development Division, Bethesda, MD,
    Search for more papers by this author
  • R. Jeffrey Goldsmith,

    1. Cincinnati VA/UC NIDA MDRU, VA Medical Center, Cincinnati, OH,
    2. Cincinnati Addiction Research Center (CinARC), University of Cincinnati College of Medicine, Cincinnati, OH,
    Search for more papers by this author
  • Florence S. Coleman,

    1. Cincinnati VA/UC NIDA MDRU, VA Medical Center, Cincinnati, OH,
    Search for more papers by this author
  • Daniel A. Bloch,

    1. Stanford University School of Medicine, Department of Health Research and Policy Division of Biostatistics, HRP Redwood Building, Stanford CA, USA
    Search for more papers by this author
  • Deborah B. Leiderman,

    1. National Institute on Drug Abuse Medications Development Division, Bethesda, MD,
    Search for more papers by this author
  • Bonita M. Singal,

    1. Cincinnati VA/UC NIDA MDRU, VA Medical Center, Cincinnati, OH,
    2. Cincinnati Addiction Research Center (CinARC), University of Cincinnati College of Medicine, Cincinnati, OH,
    Search for more papers by this author
  • Paul Berger,

    1. Cincinnati VA/UC NIDA MDRU, VA Medical Center, Cincinnati, OH,
    2. Cincinnati Addiction Research Center (CinARC), University of Cincinnati College of Medicine, Cincinnati, OH,
    Search for more papers by this author
  • Ahmed Elkashef

    1. Mental Health (116), Dayton VA Medical Center, Dayton, OH and
    Search for more papers by this author

Theresa Winhusen PhD
University of Cincinnati
3210 Jefferson Avenue
Cincinnati
Ohio 45220
USA
E-mail: winhusen@mdru.uc.edu

ABSTRACT

Aims  To conduct a preliminary evaluation of the safety and efficacy of tiagabine, sertraline or donepezil versus an unmatched placebo control as a treatment for cocaine dependence.

Design  A 10-week out-patient study was conducted using the Cocaine Rapid Efficacy and Safety Trial (CREST) study design.

Setting  This study was conducted at the Cincinnati Medication Development Research Unit (MDRU) and at an affiliated site in Dayton, Ohio.

Participants  Participants met Diagnostic and Statistical Manual version IV (DSM-IV) criteria for cocaine dependence. Sixty-seven participants were enrolled with 55 completing final study measures.

Intervention  The targeted daily doses of medication were tiagabine 20 mg, sertraline 100 mg and donepezil 10 mg. All participants received 1 hour of manualized individual cognitive behavioral therapy on a weekly basis.

Measurements  Primary outcome measures of efficacy included urine benzoylecgonine (BE) level, Cocaine Clinical Global Impression Scale–Observer and self-report of cocaine use. Safety measures included adverse events, ECGs, vital signs and laboratory tests.

Findings  Subjective measures of cocaine dependence indicated significant improvement for all study groups. Generalized estimating equations analysis indicated that the tiagabine group showed a trend toward a significant decrease in urine BE level from baseline to weeks 5–8 (P = 0.10) and non-significant changes for the other study groups. No pattern of physical or laboratory abnormalities attributable to treatment with any of the medications was identified. There were three serious adverse events reported, none of which were related to study procedures.

Conclusions  The present findings suggest that tiagabine may be worthy of further study as a cocaine dependence treatment.

Ancillary