Treatment of Cocaine Dependence With Lisdexamfetamine

Phase 2

Completed

• Conditions: Cocaine Dependence
• Interventions: Drug: lisdexamfetamine/Behavior Therapy; Other: placebo

• Registration Number: NCT00958282
• Lead Sponsor: University of Minnesota

Brief 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.

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2015-06-11
• Status Verified: 2015-08
• Results First Submitted QC: 2015-08-13
• Last Update Submitted: 2015-08-13
• Results First Posted: 2015-09-17
• Last Update Posted: 2015-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lisdexamfetamine/Behavior Therapy	lisdexamfetamine/Behavior Therapy	lisdexamfetamine 70mg/day plus Behavior Therapy
placebo	placebo	Placebo Comparator once per day

Primary Outcome Measures

Name	Time	Method
Cocaine-positive Urine Results	14 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Drug Craving	14 Weeks	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".

Trial Locations

Locations (1)

Ambulatory Research Center/Fairview University Psychiatry Dept; 🇺🇸 Minneapolis, Minnesota, United States