Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-09-30

Study Completion Date

2001-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cocaine-Related Disorders Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Dextroamphetamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

• 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes