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Assessment of the Potential Interactions Between Cocaine and GBR 12909 - 1

Double-Blind, Placebo-Controlled, Dose Escalating, Safety and Pharmacology Study With Three Dosages of GBR 12909 in Cocaine Experienced Volunteers

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00051896
Enrollment
24
Registered
2003-01-20
Start date
2002-08-31
Completion date
Unknown
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

Brief summary

The purpose of this study is to assess the potential interactions between iv cocaine and GBR 12909.

Detailed description

This is a single dose with escalation, double-blind, placebo-controlled inpatient study in which 24 cocaine experienced volunteers that meet protocol eligibility criteria during a 30 day screen period will be randomized into three dose groups.

Interventions

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Must understand study procedures and provide written informed consent * For additional inclusion criteria information, please contact study site for more information.

Exclusion criteria

* Please contact study site for more information.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameter comparison

Countries

United States

Outcome results

None listed

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