Assessment of Potential Interactions Between GBR 12909 and Cocaine - 1

Cocaine-Related Disorders Clinical Trial

Official title:

Study of Interactions Between GBR 12909 and Cocaine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00100113
• Other study ID #: NIDA-CPU-0004-1
• Status: Active, not recruiting
• Phase: Phase 1
• First received: December 22, 2004
• Last updated: January 10, 2017
• Start date: June 2004
• Est. completion date: June 2005

Study information

• Verified date: March 2005
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders

Intervention

Drug:
• GBR 12909

Locations

Country	Name	City	State
United States	U of Texas Medical Branch Galveston	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate