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NCT00617201 Clinical Trial

Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

Substance Abuse Clinical Trial

Official title:
Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00617201
Other study ID # #07-0041
Secondary ID R01DA022191
Status Completed
Phase Phase 2
First received February 5, 2008
Last updated November 13, 2012
Start date July 2007
Est. completion date August 2011

Study information
Verified date November 2012
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• atomoxetine
Once daily oral dosing
• placebo
Once daily oral dosing - matched placebo

Locations
Country Name City State
United States Straus Research Building Lexington Kentucky

Sponsors (3)
Lead Sponsor Collaborator
University of Kentucky Eli Lilly and Company, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary % Urine Samples Negative for Cocaine Total % urine samples negative for benzoylecgonine over the 12-week trial 12 weeks No
Secondary Retention Trial retention- those who complete the 12 week dosing period 12-weeks No
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