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Trial record 33 of 110 for:    nrp 104 OR lisdexamfetamine

Treatment of Cocaine Dependence With Lisdexamfetamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00958282
Recruitment Status : Completed
First Posted : August 13, 2009
Results First Posted : September 17, 2015
Last Update Posted : September 17, 2015
Information provided by (Responsible Party):
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lisdexamfetamine Treatment for Cocaine Dependence
Study Start Date : July 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Cocaine-positive Urine Results [ Time Frame: 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 :
  1. Drug Craving [ Time Frame: 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".

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00958282

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United States, Minnesota
Ambulatory Research Center/Fairview University Psychiatry Dept
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota
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Principal Investigator: Marc Mooney, Ph.D. University of Minnesota

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Responsible Party: University of Minnesota Identifier: NCT00958282     History of Changes
Other Study ID Numbers: 0812M54801
DA023548 ( Other Grant/Funding Number: NIDA )
First Posted: August 13, 2009    Key Record Dates
Results First Posted: September 17, 2015
Last Update Posted: September 17, 2015
Last Verified: August 2015
Keywords provided by University of Minnesota:
Additional relevant MeSH terms:
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Lisdexamfetamine Dimesylate
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Central Nervous System Stimulants