Reserpine for the Treatment of Cocaine Dependence - 1

This study has been completed.

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) Cincinnati VA Medical Center
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00033033

Purpose

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

Condition	Intervention	Phase
Cocaine-Related Disorders Substance-Related Disorders	Drug: Reserpine	Phase II

Drug Information available for: 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Reserpine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	Phase 2, Double-Blind, Placebo-Controlled Trial of Reserpine for the Treatment of Cocaine Dependence

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Cocaine use
Addiction severity
Cocaine withdrawal
Adverse events
Clinical improvement

Estimated Enrollment:	140
Study Start Date:	July 2001
Estimated Study Completion Date:	May 2003

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033033

Locations

United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02215
United States, Ohio
Cincinnati VA Medical Center
Cincinnati, Ohio, United States, 45220
Dayton VA Medical Center
Dayton, Ohio, United States, 45428

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Cincinnati VA Medical Center

Investigators

Principal Investigator:

Eugene Somoza, M.D., Ph.D.

Cincinnati VA Medical Center

More Information

Responsible Party:	NIDA ( Liza Gorgon / Clinical Trials Specialist )
Study ID Numbers:	NIDA-CTO-0001-1
Study First Received:	April 5, 2002
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00033033
Health Authority:	United States: Food and Drug Administration; United States: Federal Government

Study placed in the following topic categories:

Cocaine-Related Disorders
Reserpine
Mental Disorders

Substance-Related Disorders
Disorders of Environmental Origin
Cocaine

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Cardiovascular Agents
Antihypertensive Agents
Antipsychotic Agents
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009