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Reserpine for the Treatment of Cocaine Dependence - 1

Primary Purpose

Cocaine-Related Disorders, Substance-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Reserpine
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine dependence

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston University Medical Center
  • Cincinnati VA Medical Center
  • Dayton VA Medical Center

Outcomes

Primary Outcome Measures

Cocaine use
Addiction severity
Cocaine withdrawal
Adverse events
Clinical improvement

Secondary Outcome Measures

Full Information

First Posted
April 5, 2002
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Cincinnati VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00033033
Brief Title
Reserpine for the Treatment of Cocaine Dependence - 1
Official Title
Phase 2, Double-Blind, Placebo-Controlled Trial of Reserpine for the Treatment of Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Cincinnati VA Medical Center

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders, Substance-Related Disorders
Keywords
cocaine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Reserpine
Primary Outcome Measure Information:
Title
Cocaine use
Title
Addiction severity
Title
Cocaine withdrawal
Title
Adverse events
Title
Clinical improvement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Somoza, M.D., Ph.D.
Organizational Affiliation
Cincinnati VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Cincinnati VA Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Dayton VA Medical Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25969833
Citation
Winhusen TM, Lewis DF, Somoza EC, Horn P. Pharmacodynamics must inform statistics: an example from a cocaine dependence pharmacotherapy trial. ISRN Addict. 2014 Feb 5;2014:927290. doi: 10.1155/2014/927290. eCollection 2014.
Results Reference
derived
PubMed Identifier
25938124
Citation
Winhusen TM, Somoza EC, Lewis DF, Kropp F, Theobald J, Elkashef A. An Evaluation of Substance Abuse Treatment and HIV Education on Safe Sex Practices in Cocaine Dependent Individuals. ISRN Addict. 2014 Mar 4;2014:912863. doi: 10.1155/2014/912863. eCollection 2014.
Results Reference
derived

Learn more about this trial

Reserpine for the Treatment of Cocaine Dependence - 1

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