Back to resultsDextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3
Primary Purpose
Cocaine-Related Disorders, Opioid-Related Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dextroamphetamine
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine dependence
Eligibility Criteria
Inclusion Criteria- Subject must: Exhibit cocaine and opiate dependence through a DSM-IV diagnosis as determined by SCID. Be between 18 and 45 years old Women must agree to use contraception Have an EKG that has been confirmed by a cardiologist Give a cocaine positive urine during screening - Present with evidence of opiate withdrawal Exclusion Criteria- Subject must not: • Have a serious medical illness including, but not limited to the following: Hypertension Significant heart disease Clinically significant cardiovascular abnormality Angina Hepatic, renal, or gastrointestinal disorders that could result in an altered metabolism or excretion of study agent Have any Axis I disorder that is not related to drug use Have current dependence on any psychoactive disorder other than nicotine Be on probation or parole for reasons other than those related to drug charges (ASI) Be pregnant or lactating Have been in any outside treatment in 3 months
Sites / Locations
- University of Texas Health Science Center
Outcomes
Primary Outcome Measures
Craving
Drug use
Medication compliance
Retention
Addiction severity
Mood indicators
Psychiatric interview
Secondary Outcome Measures
Effectiveness measures including psycho-social variables, side effects, and self-reported measures.
Full Information
NCT ID
NCT00000306
First Posted
September 20, 1999
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Texas
1. Study Identification
Unique Protocol Identification Number
NCT00000306
Brief Title
Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3
Official Title
Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of Texas
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.
Detailed Description
This 27-week double-blind, placebo controlled treatment is designed to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients. All subjects will receive methadone. For the treatment of cocaine dependence, subjects will receive one of 2 doses of dextroamphetamine (15 or 30mg) or placebo. After 4 weeks of treatment the dose level of dextroamphetamine is doubled (30 or 60mg). This dose is maintained for 20 weeks; during which subjects attend twice weekly visits to the clinic and receive weekly cognitive behavioral therapy. Follow up evaluations will be conducted out to 3 months post treatment. Subjects will be assisted in transferring to Houston area methadone clinics to maintain treatment for opiate dependence following treatment completion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders, Opioid-Related Disorders
Keywords
cocaine dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
140 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Dextroamphetamine
Primary Outcome Measure Information:
Title
Craving
Title
Drug use
Title
Medication compliance
Title
Retention
Title
Addiction severity
Title
Mood indicators
Title
Psychiatric interview
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
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria- Subject must:
Exhibit cocaine and opiate dependence through a DSM-IV diagnosis as determined by SCID.
Be between 18 and 45 years old
Women must agree to use contraception
Have an EKG that has been confirmed by a cardiologist
Give a cocaine positive urine during screening - Present with evidence of opiate withdrawal
Exclusion Criteria- Subject must not:
• Have a serious medical illness including, but not limited to the following: Hypertension Significant heart disease Clinically significant cardiovascular abnormality Angina Hepatic, renal, or gastrointestinal disorders that could result in an altered metabolism or excretion of study agent
Have any Axis I disorder that is not related to drug use
Have current dependence on any psychoactive disorder other than nicotine
Be on probation or parole for reasons other than those related to drug charges (ASI)
Be pregnant or lactating
Have been in any outside treatment in 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Grabowski, Ph.D.
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77225
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3
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