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Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3

Sponsor
National Institute on Drug Abuse (NIDA) (NIH)
Overall Status
Completed
CT.gov ID
NCT00000306
Collaborator
University of Texas (Other)
140
Enrollment
1
Location
84
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
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 :
Sep 1, 1994
Study Completion Date :
Sep 1, 2001

Outcome Measures

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

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00000306
Other Study ID Numbers:
  • NIDA-09262-3
  • P50-09262-3
First Posted:
Sep 21, 1999
Last Update Posted:
Jan 12, 2017
Last Verified:
Oct 1, 2016
Keywords provided by , ,
cocaine dependence
Additional relevant MeSH terms:
Disease
Opioid-Related Disorders
Cocaine-Related Disorders
Dextroamphetamine

Study Results

No Results Posted as of Jan 12, 2017