Treatment of Cocaine Dependence With Lisdexamfetamine
Completed · Phase 2 · Has a placebo group
Conditions studied: Cocaine Dependence
In brief
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-week trial. The primary objectives will determine changes in cocaine use and secondary objectives will be cocaine craving and impulsivity.
Key facts
- Study ID
- NCT00958282
- Run by
- University of Minnesota
- People needed
- 43
- Starts
- 2009-07-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2015-09-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Ambulatory Research Center/Fairview University Psychiatry Dept — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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