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Treatment of Cocaine Dependence With Lisdexamfetamine

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lisdexamfetamine/Behavior Therapy
placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring cocaine, treatment, lisdexamfetamine, dependence, addiction, crack

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible participants must:

    1. Be treatment-seeking males or females between 18 and 65 years-of-age;
    2. Understand the study procedures and provide written informed consent;
    3. Be judged by the examining physician to be in generally good health with the exception of health problems related to acute drug use;
    4. Meet DSM-IV criteria for cocaine-dependence.

Exclusion Criteria:

  • Exclusion criteria include:

    1. DSM-IV diagnoses for current psychotic disorders, mood disorders (except substance-induced depression), anxiety disorders, ADHD, and other current substance dependence (except marijuana and nicotine dependence); subjects may not have physiological dependence upon alcohol requiring medical detoxification;
    2. Current use of any prescription medications;
    3. Females currently pregnant or nursing;
    4. Current elevation of liver enzyme levels above twice normal limits;
    5. Existing cardiovascular disease as determined by physician, EKG evaluation;
    6. History of significant acute or chronic physical illness precluding participation;
    7. History of hyperthyroidism, glaucoma, or seizures.

Sites / Locations

  • Ambulatory Research Center/Fairview University Psychiatry Dept

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

lisdexamfetamine/Behavior Therapy

placebo

Arm Description

lisdexamfetamine 70mg/day plus Behavior Therapy

Placebo Comparator once per day

Outcomes

Primary Outcome Measures

Cocaine-positive Urine Results
At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL.

Secondary Outcome Measures

Drug Craving
On a weekly basis, patients completed measures of cocaine craving using the Minnesota Cocaine Craving Scale. The Minnesota Cocaine Craving Scale is a self report questionnaire and ranges from 0 to 100, 0 being "very little" to 100 being "very much".

Full Information

First Posted
August 12, 2009
Last Updated
August 13, 2015
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00958282
Brief Title
Treatment of Cocaine Dependence With Lisdexamfetamine
Official Title
Lisdexamfetamine Treatment for Cocaine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (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

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This protocol is a 2-group double-blind placebo-controlled outpatient study investigating lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100 subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and secondary objectives will be cocaine craving and impulsivity.
Detailed Description
This 2-group, double-blind, placebo-controlled, 14-week study (N=100) will investigate the efficacy of cognitive behavioral therapy plus lisdexamfetamine vs. placebo to treat cocaine dependence. We hypothesize that lisdexamfetamine will reduce cocaine use (primary outcome), as well as cocaine craving and impulsivity (secondary outcomes) vs. placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
cocaine, treatment, lisdexamfetamine, dependence, addiction, crack

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lisdexamfetamine/Behavior Therapy
Arm Type
Active Comparator
Arm Description
lisdexamfetamine 70mg/day plus Behavior Therapy
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator once per day
Intervention Type
Drug
Intervention Name(s)
lisdexamfetamine/Behavior Therapy
Intervention Type
Other
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Cocaine-positive Urine Results
Description
At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL.
Time Frame
14 Weeks
Secondary Outcome Measure Information:
Title
Drug Craving
Description
On a weekly basis, patients completed measures of cocaine craving using the Minnesota Cocaine Craving Scale. The Minnesota Cocaine Craving Scale is a self report questionnaire and ranges from 0 to 100, 0 being "very little" to 100 being "very much".
Time Frame
14 Weeks

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: Eligible participants must: Be treatment-seeking males or females between 18 and 65 years-of-age; Understand the study procedures and provide written informed consent; Be judged by the examining physician to be in generally good health with the exception of health problems related to acute drug use; Meet DSM-IV criteria for cocaine-dependence. Exclusion Criteria: Exclusion criteria include: DSM-IV diagnoses for current psychotic disorders, mood disorders (except substance-induced depression), anxiety disorders, ADHD, and other current substance dependence (except marijuana and nicotine dependence); subjects may not have physiological dependence upon alcohol requiring medical detoxification; Current use of any prescription medications; Females currently pregnant or nursing; Current elevation of liver enzyme levels above twice normal limits; Existing cardiovascular disease as determined by physician, EKG evaluation; History of significant acute or chronic physical illness precluding participation; History of hyperthyroidism, glaucoma, or seizures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Mooney, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ambulatory Research Center/Fairview University Psychiatry Dept
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

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Treatment of Cocaine Dependence With Lisdexamfetamine

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