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Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence

This study is currently recruiting participants.
Verified September 2012 by University of Minnesota - Clinical and Translational Science Institute
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: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Cocaine Dependence
 Drug: lisdexamfetamine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
lisdexamfetamine
open label
 Drug: lisdexamfetamine
20mg q.d. to 70mg b.i.d
Other Name: vyvanse

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.

  Eligibility

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

.Inclusion Criteria:

  1. Men and women between the ages of 18-65 who meet DSM-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, DBP> 90, or HR > 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490216

Contacts
Contact: David Babb 612-627-4824 babbx001@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Marc E 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
ClinicalTrials.gov Identifier: NCT01490216     History of Changes
Other Study ID Numbers: 3002-11961-00006857
Study First Received: December 8, 2011
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Cocaine
Dextroamphetamine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on June 17, 2013