Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01490216
First received: December 8, 2011
Last updated: November 12, 2013
Last verified: November 2013

December 8, 2011
November 12, 2013
July 2011
January 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01490216 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence
Open-Label Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence

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

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

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cocaine Dependence
Drug: lisdexamfetamine
20mg q.d. to 70mg b.i.d
Other Name: vyvanse
lisdexamfetamine
open label
Intervention: Drug: lisdexamfetamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
January 2013
January 2013   (final data collection date for primary outcome measure)

.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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01490216
3002-11961-00006857
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: Marc E Mooney, Ph.D. University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
November 2013

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