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Reserpine for the Treatment of Cocaine Dependence - 1

Information source: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine-Related Disorders; Substance-Related Disorders

Intervention: Reserpine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Eugene Somoza, M.D., Ph.D., Principal Investigator, Affiliation: Cincinnati VA Medical Center

Summary

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

Clinical Details

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

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

Primary outcome:

Cocaine use

Addiction severity

Cocaine withdrawal

Adverse events

Clinical improvement

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Boston University Medical Center, Boston, Massachusetts 02215, United States

Cincinnati VA Medical Center, Cincinnati, Ohio 45220, United States

Dayton VA Medical Center, Dayton, Ohio 45428, United States

Additional Information

Starting date: July 2001
Last updated: August 15, 2008

Page last updated: August 23, 2015

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