Assessment of Potential Interactions Between GBR 12909 and Cocaine - 1

NCT ID: NCT00100113

Last Updated: 2017-01-11

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-06-30

Brief Summary

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The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and 3 doses of GBR 12909.

Detailed Description

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This is Phase 1, double-blind, placebo-controlled human laboratory clinical pharmacology study that will assess the potential interactions between IV cocaine and 3 escalating oral doses of GBR 12909. The primary objective is to determine safety of GBR 12909 administration and if there are significant interactions between GBR 12909 treatment concurrent with IV cocaine infusions.

Conditions

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Cocaine-Related Disorders

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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GBR 12909

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must be within 20% ideal body weight and must weigh at least 45 kg.
* Must understand the study procedures and provide written informed consent.
* Must meet DSM-4 criteria and are non-treatment seeking at time of study.

Exclusion Criteria

* Please contact study site for more information
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Principal Investigators

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Kathryn Cunningham, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas Medical Branch - Galveston

Locations

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U of Texas Medical Branch Galveston

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NIDA-CPU-0004-1

Identifier Type: -

Identifier Source: org_study_id

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