Status:
COMPLETED
Treatment of Cocaine Dependence With Lisdexamfetamine
Lead Sponsor:
University of Minnesota
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This protocol is a 2-group double-blind placebo-controlled outpatient study investigating lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100 subjects in a 14-we...
Detailed Description
This 2-group, double-blind, placebo-controlled, 14-week study (N=100) will investigate the efficacy of cognitive behavioral therapy plus lisdexamfetamine vs. placebo to treat cocaine dependence. We hy...
Eligibility Criteria
Inclusion
- Eligible participants must:
- Be treatment-seeking males or females between 18 and 65 years-of-age;
- Understand the study procedures and provide written informed consent;
- Be judged by the examining physician to be in generally good health with the exception of health problems related to acute drug use;
- Meet DSM-IV criteria for cocaine-dependence.
Exclusion
- Exclusion criteria include:
- DSM-IV diagnoses for current psychotic disorders, mood disorders (except substance-induced depression), anxiety disorders, ADHD, and other current substance dependence (except marijuana and nicotine dependence); subjects may not have physiological dependence upon alcohol requiring medical detoxification;
- Current use of any prescription medications;
- Females currently pregnant or nursing;
- Current elevation of liver enzyme levels above twice normal limits;
- Existing cardiovascular disease as determined by physician, EKG evaluation;
- History of significant acute or chronic physical illness precluding participation;
- History of hyperthyroidism, glaucoma, or seizures.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00958282
Start Date
July 1 2009
End Date
January 1 2013
Last Update
September 17 2015
Active Locations (1)
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1
Ambulatory Research Center/Fairview University Psychiatry Dept
Minneapolis, Minnesota, United States, 55454