Reserpine for the Treatment of Cocaine Dependence - 1

This study has been completed.
Sponsor:
Collaborator:
Cincinnati VA Medical Center
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00033033
First received: April 5, 2002
Last updated: August 15, 2008
Last verified: August 2008
  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 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.

  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
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 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
Cincinnati VA Medical Center
Investigators
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
ClinicalTrials.gov 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:
Substance-Related Disorders
Disease
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes
Reserpine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014