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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000306
Other study ID # NIDA-09262-3
Secondary ID P50-09262-3
Status Completed
Phase Phase 2
First received September 20, 1999
Last updated January 11, 2017
Start date September 1994
Est. completion date September 2001

Study information

Verified date October 2016
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date September 2001
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Dextroamphetamine


Locations

Country Name City State
United States University of Texas Health Science Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA) University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Craving
Primary Drug use
Primary Medication compliance
Primary Retention
Primary Addiction severity
Primary Mood indicators
Primary Psychiatric interview
Secondary Effectiveness measures including psycho-social variables, side effects, and self-reported measures.
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