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Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence

Sponsor
University of Minnesota (Other)
Overall Status
Terminated
CT.gov ID
NCT01490216
Collaborator
(none)
43
Enrollment
1
Location
1
Arm
18.1
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate ideal dose or lisdexamfetamine and tolerability, plus reduction in cocaine use and craving.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Evaluate ideal dose or lisdexamfetamine and tolerability, plus reduction in cocaine use and craving as determined by self-report and cocaine-positive urine samples.

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Open-Label Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence
Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Other: lisdexamfetamine

open label

Drug: lisdexamfetamine
20mg q.d. to 70mg b.i.d
Other Names:
  • vyvanse

    		•

    Outcome Measures

    Primary Outcome Measures

    1. maximum total lisdexamfetamine dose achieved during the study period defined as the highest amount of medication per day maintained for a seven day period [Study weeks 3-6]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    .Inclusion Criteria:

    1. Men and women between the ages of 18-65 who meet Diagnostic and Statistical Manual -IV criteria for current cocaine dependence

    2. Used cocaine at least four days in the past month

    3. Individuals must be in good general health

    4. Individuals must be capable of giving informed consent and capable of complying with study procedures

    5. Women of child-bearing age must agree to use a method of contraception with proven efficacy, consisting of one of the following: 1) Any form of hormonal contraception;

    1. Intra-uterine device; 3) Sterilization; 4) Double-barrier contraception which is a combination of two of the following: condoms, spermicide, diaphragm. Pregnancy tests will be performed monthly and if a woman becomes pregnant, the study medication will be discontinued.
    Exclusion Criteria:

    1. Individuals who meet DSM-IV-TR criteria for bipolar disorder, schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse

    2. Individuals with any other current Axis I psychiatric disorder as defined by DSM-IV-TR that in the investigator's judgment are unstable, or would be disrupted by study medication, or are likely to require pharmacotherapy during the study period

    3. Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention

    4. Individuals with current psychostimulant abuse or dependence (other than cocaine dependence)

    5. Individuals with current suicidal risk

    6. Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms

    7. Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (SBP > 140, diastolic blood pressure > 90, or heart rate > 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases (< 3x upper limit of normal are acceptable), or uncontrolled diabetes

    8. Individuals with a history of seizures, hyperthyroidism and/or glaucoma

    9. History of allergic reaction to study medication

    10. Women who are pregnant or nursing

    11. Currently being prescribed psychotropic medication by another physician (other than sleep medication)

    12. Individuals who are legally mandated (e.g., to avoid incarceration) to participate in substance abuse treatment program

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Minneapolis Minnesota United States 55454

    Sponsors and Collaborators

    • University of Minnesota

    Investigators

    • Principal Investigator: Marc E Mooney, Ph.D., University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT01490216
    Other Study ID Numbers:
    • 3002-11961-00006857
    First Posted:
    Dec 12, 2011
    Last Update Posted:
    Jul 15, 2019
    Last Verified:
    Jul 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Minnesota
    cocaine
    lisdexamfetamine
    vyvanse
    Additional relevant MeSH terms:
    Cocaine-Related Disorders
    Lisdexamfetamine Dimesylate

    Study Results

    No Results Posted as of Jul 15, 2019