Reserpine for the Treatment of Cocaine Dependence - 1

NCT ID: NCT00033033

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2003-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cocaine-Related Disorders Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Reserpine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cincinnati VA Medical Center

OTHER_GOV

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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NIDA

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Cincinnati VA Medical Center

Locations

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Boston University Medical Center

Boston, Massachusetts, United States

Site Status

Cincinnati VA Medical Center

Cincinnati, Ohio, United States

Site Status

Dayton VA Medical Center

Dayton, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25969833 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25938124 (View on PubMed)

Other Identifiers

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NIDA-CTO-0001-1

Identifier Type: -

Identifier Source: org_study_id

NCT00024869

Identifier Type: -

Identifier Source: nct_alias

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