Phase 1, Double-Blind, Placebo-Controlled Multiple Dose Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine

National Institute on Drug Abuse (NIDA)1 site in 1 country16 target enrollmentAugust 2005

ConditionsCocaine-Related Disorders

DrugsAtomoxetine

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cocaine-Related Disorders
Sponsor: National Institute on Drug Abuse (NIDA)
Enrollment: 16
Locations: 1
Primary Endpoint: Cardiovascular responses
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess potential interactions between intravenous (i.v.) cocaine and atomoxetine (Strattera) administered orally in four escalating doses.

Registry

clinicaltrials.gov

Start Date

August 2005

End Date

September 2006

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

National Institute on Drug Abuse (NIDA)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18-45 years of age who are not seeking treatment at the time of the study
•Must be able to provide written informed consent
•Must be within 20 percent of ideal body weight and weigh at least 45 kg
•Must meet DSM0IV diagnostic criteria for cocaine abuse or dependence
•Must currently be using cocaine as confirmed by a positive BE
•If female and of child bearing potential, must agree to the use of birth control