Treatment of Cocaine Dependence With Lisdexamfetamine

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Cocaine; Lisdexamfetamine Dimesylate

Criteria

Inclusion Criteria:

• Eligible participants must:

1. Be treatment-seeking males or females between 18 and 65 years-of-age;

2. Understand the study procedures and provide written informed consent;

3. Be judged by the examining physician to be in generally good health with the exception of health problems related to acute drug use;

4. Meet DSM-IV criteria for cocaine-dependence.

Exclusion Criteria:

• Exclusion criteria include:

1. 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;

2. Current use of any prescription medications;

3. Females currently pregnant or nursing;

4. Current elevation of liver enzyme levels above twice normal limits;

5. Existing cardiovascular disease as determined by physician, EKG evaluation;

6. History of significant acute or chronic physical illness precluding participation;

7. History of hyperthyroidism, glaucoma, or seizures.