Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

Phase 2

Completed

• Conditions: Substance Abuse
• Interventions: Drug: placebo; Drug: atomoxetine

• Registration Number: NCT00617201
• Lead Sponsor: Sharon Walsh

Brief Summary

This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve maintenance on the assigned active dose safely. Contingency management procedures will be used to reinforce attendance and compliance with study procedures. Primary outcome measures will include urinalysis data assessing cocaine use.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-02-05
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-15
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2012-11-13
• Results First Submitted QC: 2012-11-13
• Results First Posted: 2012-12-11
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Seeking treatment for cocaine dependence
• Must have used cocaine in the past 30 days

Read More

Exclusion Criteria

• Physical dependence on any drug requiring medical management
• Any major medical or psychiatric disorder that would be contraindicated for participation
• Cardiovascular disease
• Seizures or significant head injuries
• Currently taking atomoxetine
• Pregnant or breast-feeding

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	Matched Placebo
1	atomoxetine	Atomoxetine

Primary Outcome Measures

Name	Time	Method
% Urine Samples Negative for Cocaine	Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks	Total % urine samples negative for benzoylecgonine over the 12-week trial

Secondary Outcome Measures

Name	Time	Method
Retention	12-weeks	Trial retention- those who complete the 12 week dosing period

Trial Locations

Locations (1)

Straus Research Building; 🇺🇸 Lexington, Kentucky, United States