Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1

Phase 1

Completed

• Conditions: Cocaine-Related Disorders

• Registration Number: NCT00265265
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-12-13
• Study First Submitted QC: 2005-12-13
• Study First Posted: 2005-12-14
• Primary Completion: 2006-09
• Status Verified: 2016-08
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Exclusion Criteria

• please contact the site directly for more information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety
Cardiovascular responses

Secondary Outcome Measures

Name	Time	Method
Abuse Liability
Mood and personality assessments
Cocaine craving
pharmacokinetic assessment
Psychological Effects of Cocaine

Trial Locations

Locations (1)

Uniformed Services University of Health Science; 🇺🇸 Bethesda, Maryland, United States