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.
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 hypothesize that lisdexamfetamine will reduce cocaine use (primary outcome), as well as cocaine craving and impulsivity (secondary outcomes) vs. placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
Ambulatory Research Center/Fairview University Psychiatry Dept
Minneapolis, Minnesota, United States
Cocaine-positive Urine Results
At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL.
Time frame: 14 Weeks
Drug Craving
On a weekly basis, patients completed measures of cocaine craving using the Minnesota Cocaine Craving Scale. The Minnesota Cocaine Craving Scale is a self report questionnaire and ranges from 0 to 100, 0 being "very little" to 100 being "very much".
Time frame: 14 Weeks
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