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Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3

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: NCT00000306
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : January 12, 2017
Sponsor:
Collaborator:
University of Texas
Information provided by:
National Institute on Drug Abuse (NIDA)

Study Description
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Brief Summary:
The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Opioid-Related Disorders Drug: Dextroamphetamine Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients
Study Start Date : September 1994
Study Completion Date : September 2001

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Craving
  2. Drug use
  3. Medication compliance
  4. Retention
  5. Addiction severity
  6. Mood indicators
  7. Psychiatric interview

Secondary Outcome Measures :
  1. Effectiveness measures including psycho-social variables, side effects, and self-reported measures.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT00000306


Locations
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United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77225
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
University of Texas
Investigators
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Principal Investigator: John Grabowski, Ph.D. University of Texas
More Information
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ClinicalTrials.gov Identifier: NCT00000306    
Other Study ID Numbers: NIDA-09262-3
P50-09262-3
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2016
Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence
Additional relevant MeSH terms:
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Disease
Opioid-Related Disorders
Cocaine-Related Disorders
Pathologic Processes
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dextroamphetamine
 Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents