Back to resultsTreatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo
Primary Purpose
Cocaine-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dextro-Amphetamine Sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring Cocaine Abuse, Dextro-Amphetamine Sulfate
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of cocaine dependence, as determined by the Structured Clinical Interview for DSM-IV Agreement to use an adequate method of contraception for the duration of the study Electrocardiogram confirmation by a cardiologist Cocaine-positive urine test prior to study entry Exclusion Criteria: High blood pressure Significant heart disease Clinically significant cardiovascular abnormality Angina Kidney, liver, or gastrointestinal disorder Current Axis I disorder not related to drug use Current dependence on any drug other than nicotine Attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) On probation or parole for reasons other than those related to drug abuse charges Pregnant or breastfeeding Sought treatment for drug dependence within 3 months prior to study entry Currently taking prescribed medications
Sites / Locations
- The University of Texas Health Science Center at Houston
Outcomes
Primary Outcome Measures
Substance use and retention
Secondary Outcome Measures
Effectiveness measures, including psycho-social variables, side effects, and self-reported measures
Full Information
NCT ID
NCT00218348
First Posted
September 16, 2005
Last Updated
December 16, 2017
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00218348
Brief Title
Treatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo
Official Title
Pharmacotherapy for Cocaine Dependence - 1
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
Dextro-amphetamine sulfate is a central nervous system stimulant that increases the release of the neurotransmitter dopamine in the brain. The purpose of this study is to further examine dose ranges of dextro-amphetamine sulfate as a treatment for cocaine dependence.
Detailed Description
This randomized, double-blind dose study will compare the effectiveness of three active medication doses of dextro-amphetamine sulfate to placebo in the treatment of cocaine dependence. Participants will be randomly assigned to one of the four following dosages of dextro-amphetamine sulfate: 0 mg, 40 mg, 60 mg, or 80 mg. Participants will undergo a 2-week stabilization period followed by a 25-week study period. The study period will include administration of the stable medication dose for 21 weeks, followed by 1 week of dose reduction, and then 3 weeks without medication. All participants will receive weekly cognitive behavioral therapy and electrocardiograms. Participants will be given the option to participate in a voluntary plasma blood draw during Weeks 4, 8, and 20 and will be scheduled for follow-up assessments at Months 1 and 3 post-treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders
Keywords
Cocaine Abuse, Dextro-Amphetamine Sulfate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dextro-Amphetamine Sulfate
Primary Outcome Measure Information:
Title
Substance use and retention
Secondary Outcome Measure Information:
Title
Effectiveness measures, including psycho-social variables, side effects, and self-reported measures
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-IV diagnosis of cocaine dependence, as determined by the Structured Clinical Interview for DSM-IV
Agreement to use an adequate method of contraception for the duration of the study
Electrocardiogram confirmation by a cardiologist
Cocaine-positive urine test prior to study entry
Exclusion Criteria:
High blood pressure
Significant heart disease
Clinically significant cardiovascular abnormality
Angina
Kidney, liver, or gastrointestinal disorder
Current Axis I disorder not related to drug use
Current dependence on any drug other than nicotine
Attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD)
On probation or parole for reasons other than those related to drug abuse charges
Pregnant or breastfeeding
Sought treatment for drug dependence within 3 months prior to study entry
Currently taking prescribed medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy M Schmitz, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo
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