Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial
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,...
Brief Summary
Official Title: “Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: August 2011
Intervention(s) in this Clinical Trial
- Drug: atomoxetine
- Once daily oral dosing
- Drug: placebo
- Once daily oral dosing - matched placebo
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Active drug
- Placebo Comparator: 2
- Matched Placebo
Outcome Measures for this Clinical Trial
Primary Measures
- Urine samples negative for cocaine
- Time Frame: 12 weeks
Safety Issue?: No
- Time Frame: 12 weeks
Secondary Measures
- Self-reported drug use Self-reported psychosocial function Adverse events and Side Effects
- Time Frame: 12-weeks
Safety Issue?: Yes
- Time Frame: 12-weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 60 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: University of Kentucky Other
Overall Clinical Trial Officials and Contacts
Sharon L Walsh, Ph.D. Principal Investigator University of Kentucky
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00617201
Study ID Number: #07-0041
ClinicalTrials.gov Identifier: NCT00617201
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00617201
