Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence
Primary Purpose
Cocaine Dependence
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lisdexamfetamine
Sponsored by
About this trial
This is an interventional basic science trial for Cocaine Dependence focused on measuring cocaine, lisdexamfetamine, vyvanse
Eligibility Criteria
.Inclusion Criteria:
- Men and women between the ages of 18-65 who meet Diagnostic and Statistical Manual -IV criteria for current cocaine dependence
- Used cocaine at least four days in the past month
- Individuals must be in good general health
- Individuals must be capable of giving informed consent and capable of complying with study procedures
- 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:
- Individuals who meet DSM-IV-TR criteria for bipolar disorder, schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse
- 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
- Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention
- Individuals with current psychostimulant abuse or dependence (other than cocaine dependence)
- Individuals with current suicidal risk
- Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
- 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
- Individuals with a history of seizures, hyperthyroidism and/or glaucoma
- History of allergic reaction to study medication
- Women who are pregnant or nursing
- Currently being prescribed psychotropic medication by another physician (other than sleep medication)
- Individuals who are legally mandated (e.g., to avoid incarceration) to participate in substance abuse treatment program
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
lisdexamfetamine
Arm Description
open label
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01490216
First Posted
December 8, 2011
Last Updated
July 11, 2019
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01490216
Brief Title
Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence
Official Title
Open-Label Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
cocaine, lisdexamfetamine, vyvanse
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lisdexamfetamine
Arm Type
Other
Arm Description
open label
Intervention Type
Drug
Intervention Name(s)
lisdexamfetamine
Other Intervention Name(s)
vyvanse
Intervention Description
20mg q.d. to 70mg b.i.d
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
.Inclusion Criteria:
Men and women between the ages of 18-65 who meet Diagnostic and Statistical Manual -IV criteria for current cocaine dependence
Used cocaine at least four days in the past month
Individuals must be in good general health
Individuals must be capable of giving informed consent and capable of complying with study procedures
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:
Individuals who meet DSM-IV-TR criteria for bipolar disorder, schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse
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
Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention
Individuals with current psychostimulant abuse or dependence (other than cocaine dependence)
Individuals with current suicidal risk
Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
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
Individuals with a history of seizures, hyperthyroidism and/or glaucoma
History of allergic reaction to study medication
Women who are pregnant or nursing
Currently being prescribed psychotropic medication by another physician (other than sleep medication)
Individuals who are legally mandated (e.g., to avoid incarceration) to participate in substance abuse treatment program
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc E Mooney, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence
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