Reserpine for the Treatment of Cocaine Dependence - 1

This study has been completed.
Cincinnati VA Medical Center
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: April 5, 2002
Last updated: August 15, 2008
Last verified: August 2008
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 2

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

Resource links provided by NLM:

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00033033

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
Principal Investigator: Eugene Somoza, M.D., Ph.D. Cincinnati VA Medical Center
  More Information

No publications provided

Responsible Party: Liza Gorgon / Clinical Trials Specialist, NIDA Identifier: NCT00033033     History of Changes
Obsolete Identifiers: NCT00024869
Other Study ID Numbers: NIDA-CTO-0001-1 
Study First Received: April 5, 2002
Last Updated: August 15, 2008
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antihypertensive Agents
Antipsychotic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on February 08, 2016