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NCT00033033 Clinical Trial

Reserpine for the Treatment of Cocaine Dependence - 1

Substance-Related Disorders Clinical Trial

Official title:
Phase 2, Double-Blind, Placebo-Controlled Trial of Reserpine for the Treatment of Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00033033
Other study ID # NIDA-CTO-0001-1
Secondary ID
Status Completed
Phase Phase 2
First received April 5, 2002
Last updated January 11, 2017
Start date July 2001
Est. completion date May 2003

Study information
Verified date August 2008
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Federal Government
Study type Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers
  • NCT00024869

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date May 2003
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Reserpine

Locations
Country Name City State
United States Boston University Medical Center Boston Massachusetts
United States Cincinnati VA Medical Center Cincinnati Ohio
United States Dayton VA Medical Center Dayton Ohio

Sponsors (2)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA) Cincinnati VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cocaine use
Primary Addiction severity
Primary Cocaine withdrawal
Primary Adverse events
Primary Clinical improvement
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