Treatment of Cocaine Dependence With Lisdexamfetamine

Cocaine Dependence Clinical Trial

Official title:

Lisdexamfetamine Treatment for Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958282
• Other study ID #: 0812M54801
• Secondary ID: DA023548
• Status: Completed
• Phase: Phase 2
• First received: August 12, 2009
• Last updated: August 13, 2015
• Start date: July 2009
• Est. completion date: January 2013

Study information

• Verified date: August 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• lisdexamfetamine/Behavior Therapy

Other:
• placebo

Locations

Country	Name	City	State
United States	Ambulatory Research Center/Fairview University Psychiatry Dept	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No