Assessment of Potential Interactions Between GBR 12909 and Cocaine - 1

Study of Interactions Between GBR 12909 and Cocaine

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00100113

Enrollment

Registered

2004-12-23

Start date

2004-06-30

Completion date

2005-06-30

Last updated

2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine-Related Disorders

Keywords

cocaine dependence

Brief summary

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

Detailed 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.

Interventions

DRUGGBR 12909

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Heart rate	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026