Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3

National Institute on Drug Abuse (NIDA)140 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

140

Conditions

Interventions

DextroamphetamineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Texas Health Science Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Craving

Drug use

Medication compliance

Retention

Addiction severity

Mood indicators

Psychiatric interview

Secondary Outcomes

Effectiveness measures including psycho-social variables, side effects, and self-reported measures.

Data from ClinicalTrials.gov

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