Treatment of Cocaine Dependence With Lisdexamfetamine

University of Minnesota (UMN)

Status and phase

Completed

Phase 2

Conditions

Cocaine Dependence

Treatments

Other: placebo

Drug: lisdexamfetamine/Behavior Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00958282

0812M54801

DA023548 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.