Treatment of Cocaine Dependence With Lisdexamfetamine

This study has been completed.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute Identifier:
First received: August 12, 2009
Last updated: August 13, 2015
Last verified: August 2015
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.

Condition Intervention Phase
Cocaine Dependence
Drug: lisdexamfetamine/Behavior Therapy
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lisdexamfetamine Treatment for Cocaine Dependence

Resource links provided by NLM:

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Cocaine-positive Urine Results [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    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:
  • Drug Craving [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]

    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".

Enrollment: 43
Study Start Date: July 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lisdexamfetamine/Behavior Therapy
lisdexamfetamine 70mg/day plus Behavior Therapy
Drug: lisdexamfetamine/Behavior Therapy
Placebo Comparator: placebo
Placebo Comparator once per day
Other: placebo

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.

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00958282

United States, Minnesota
Ambulatory Research Center/Fairview University Psychiatry Dept
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Marc Mooney, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute Identifier: NCT00958282     History of Changes
Other Study ID Numbers: 0812M54801, DA023548
Study First Received: August 12, 2009
Results First Received: June 11, 2015
Last Updated: August 13, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 24, 2015