This trial is active, not recruiting.

Condition cocaine-related disorders
Treatment gbr 12909
Phase phase 1
Sponsor National Institute on Drug Abuse (NIDA)
Start date June 2004
End date June 2005
Trial size 24 participants
Trial identifier NCT00100113, NIDA-CPU-0004-1


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

Heart rate
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title Study of Interactions Between GBR 12909 and Cocaine
Principal investigator Kathryn Cunningham, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2007.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).