Reserpine for the Treatment of Cocaine Dependence – 1

Overview

The purpose of this study is to assess the efficacy and safety of reserpine for the treatment of cocaine dependence.

Full Title of Study: “Phase 2, Double-Blind, Placebo-Controlled Trial of Reserpine for the Treatment of Cocaine Dependence”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Detailed Description

To assess the efficacy and safety of reserpine in reducing cocaine use in subjects with cocaine dependence. This is a double-blind, placebo-controlled, parallel-group design with a 2 week baseline period.

Interventions

  • Drug: Reserpine

Clinical Trial Outcome Measures

Primary Measures

  • Cocaine use
  • Addiction severity
  • Cocaine withdrawal
  • Adverse events
  • Clinical improvement

Participating in This Clinical Trial

Inclusion Criteria

Be at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; treatment seeking individuals; have the ability to understand and provide written informed consent; females of child bearing potential using appropriate birth control method Exclusion Criteria:

Additional criteria available during screening at the site.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Institute on Drug Abuse (NIDA)
  • Collaborator
    • Cincinnati VA Medical Center
  • Provider of Information About this Clinical Study
    • Liza Gorgon / Clinical Trials Specialist, NIDA
  • Overall Official(s)
    • Eugene Somoza, M.D., Ph.D., Principal Investigator, Cincinnati VA Medical Center

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