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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.
ClinicalTrials.gov Identifier: NCT01490216
Recruitment Status : Completed
First Posted : December 12, 2011
Last Update Posted : November 13, 2013
Information provided by (Responsible Party):

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
Cocaine Dependence Drug: lisdexamfetamine Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence
Study Start Date : July 2011
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
open label
Drug: lisdexamfetamine
20mg q.d. to 70mg b.i.d
Other Name: 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 [ Time Frame: Study weeks 3-6 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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; 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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01490216

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Marc E Mooney, Ph.D. University of Minnesota - Clinical and Translational Science Institute
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01490216     History of Changes
Other Study ID Numbers: 3002-11961-00006857
First Posted: December 12, 2011    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

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

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Lisdexamfetamine Dimesylate
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