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Trial record 12 of 111 for:    nrp 104 OR lisdexamfetamine

Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence

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: NCT01490216
Recruitment Status : Terminated (Low enrollment)
First Posted : December 12, 2011
Last Update Posted : July 15, 2019
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE December 8, 2011
First Posted Date  ICMJE December 12, 2011
Last Update Posted Date July 15, 2019
Study Start Date  ICMJE July 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2011)
maximum total lisdexamfetamine dose achieved during the study period defined as the highest amount of medication per day maintained for a seven day period [ Time Frame: Study weeks 3-6 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01490216 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence
Official Title  ICMJE Open-Label Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence
Brief Summary The purpose of this study is to evaluate ideal dose or lisdexamfetamine and tolerability, plus reduction in cocaine use and craving.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Cocaine Dependence
Intervention  ICMJE Drug: lisdexamfetamine
20mg q.d. to 70mg b.i.d
Other Name: vyvanse
Study Arms  ICMJE lisdexamfetamine
open label
Intervention: Drug: lisdexamfetamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 11, 2019)
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2011)
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

.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; 2) 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01490216
Other Study ID Numbers  ICMJE 3002-11961-00006857
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc E Mooney, Ph.D. University of Minnesota
PRS Account University of Minnesota
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP