Assessment of Potential Interactions Between GBR 12909 and Cocaine - 1

National Institutes of Health (NIH)

Status and phase: Unknown; Phase 1

Conditions: Cocaine-Related Disorders

Treatments: Drug: GBR 12909

Study type: Interventional

Funder types: NIH

Identifiers

NCT00100113

NIDA-CPU-0004-1

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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