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Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3

This study has been completed.
Sponsor:
Collaborator:
University of Texas
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00000306
First received: September 20, 1999
Last updated: August 11, 2008
Last verified: August 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Cocaine-Related Disorders
Opioid-Related Disorders
 Drug: Dextroamphetamine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

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.

Estimated Enrollment: 140
Study Start Date: September 1994
Estimated Study Completion Date: September 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000306

Locations
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
Principal Investigator: John Grabowski, Ph.D. University of Texas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00000306     History of Changes
Other Study ID Numbers: NIDA-09262-3, P50-09262-3
Study First Received: September 20, 1999
Last Updated: August 11, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Opioid-Related Disorders
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Dextroamphetamine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013