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Reserpine for the Treatment of Cocaine Dependence - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00033033
Recruitment Status : Completed
First Posted : April 8, 2002
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
Cincinnati VA Medical Center
Information provided by:
National Institute on Drug Abuse (NIDA)

Study Description
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Brief Summary:
The purpose of this study is to assess the efficacy and safety of reserpine for the treatment of cocaine dependence.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Substance-Related Disorders Drug: Reserpine Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Double-Blind, Placebo-Controlled Trial of Reserpine for the Treatment of Cocaine Dependence
Study Start Date : July 2001
Study Completion Date : May 2003

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Cocaine use
  2. Addiction severity
  3. Cocaine withdrawal
  4. Adverse events
  5. Clinical improvement

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033033


Locations
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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
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Principal Investigator: Eugene Somoza, M.D., Ph.D. Cincinnati VA Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Liza Gorgon / Clinical Trials Specialist, NIDA
ClinicalTrials.gov Identifier: NCT00033033    
Obsolete Identifiers: NCT00024869
Other Study ID Numbers: NIDA-CTO-0001-1
First Posted: April 8, 2002    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: August 2008
Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence
Additional relevant MeSH terms:
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Disease
Cocaine-Related Disorders
Substance-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Reserpine
Antihypertensive Agents
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents