Treatment of Cocaine Dependence With Lisdexamfetamine
Information source: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine Dependence
Intervention: lisdexamfetamine (Drug); placebo (Drug); cognitive behavioral therapy (Behavioral)
Phase: Phase 2
Status: Completed
Sponsored by: University of Minnesota - Clinical and Translational Science Institute Official(s) and/or principal investigator(s): David V Herin, Ph.D., Principal Investigator, Affiliation: University of Minnesota - Clinical and Translational Science Institute
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.
Clinical Details
Official title: Lisdexamfetamine Treatment for Cocaine Dependence
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Cocaine-positive urine results
Secondary outcome: Drug craving, impulsivity
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Ambulatory Research Center/Fairview University Psychiatry Dept, Minneapolis, Minnesota 55454, United States
Additional Information
Starting date: July 2009
Last updated: November 12, 2013
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