Overview

Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Sharon Walsh
University of Kentucky
Collaborators:
Eli Lilly and Company
National Institute on Drug Abuse (NIDA)
Treatments:
Atomoxetine Hydrochloride
Cocaine
Criteria
Inclusion Criteria:

- Seeking treatment for cocaine dependence

- Must have used cocaine in the past 30 days

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