Treatment of Cocaine Dependence With Lisdexamfetamine
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|ClinicalTrials.gov Identifier: NCT00958282|
Recruitment Status : Completed
First Posted : August 13, 2009
Results First Posted : September 17, 2015
Last Update Posted : September 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence||Drug: lisdexamfetamine/Behavior Therapy Other: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Lisdexamfetamine Treatment for Cocaine Dependence|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Active Comparator: lisdexamfetamine/Behavior Therapy
lisdexamfetamine 70mg/day plus Behavior Therapy
|Drug: lisdexamfetamine/Behavior Therapy|
Placebo Comparator: placebo
Placebo Comparator once per day
- Cocaine-positive Urine Results [ Time Frame: 14 Weeks ]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 ]
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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|