Treatment of Cocaine Dependence With Lisdexamfetamine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Lisdexamfetamine Treatment for Cocaine Dependence

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: lisdexamfetamine/Behavior Therapy
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lisdexamfetamine/Behavior Therapy<br>lisdexamfetamine 70mg/day plus Behavior Therapy | Drug: lisdexamfetamine/Behavior Therapy<br> <br> |
| Placebo Comparator: placebo<br>Placebo Comparator once per day | Other: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cocaine, treatment, lisdexamfetamine, dependence, addiction, crack