Treatment of Cocaine Dependence With Lisdexamfetamine
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.
Drug: lisdexamfetamine/Behavior Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Lisdexamfetamine Treatment for Cocaine Dependence|
- Cocaine-positive Urine Results [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]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.
- Drug Craving [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
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".
|Study Start Date:||July 2009|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Active Comparator: lisdexamfetamine/Behavior Therapy
lisdexamfetamine 70mg/day plus Behavior Therapy
|Drug: lisdexamfetamine/Behavior Therapy|
Placebo Comparator: placebo
Placebo Comparator once per day
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958282
|United States, Minnesota|
|Ambulatory Research Center/Fairview University Psychiatry Dept|
|Minneapolis, Minnesota, United States, 55454|
|Principal Investigator:||Marc Mooney, Ph.D.||University of Minnesota - Clinical and Translational Science Institute|