Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3

National Institutes of Health (NIH)

Status and phase

Completed

Phase 2

Conditions

Opioid-Related Disorders

Cocaine-Related Disorders

Treatments

Drug: Dextroamphetamine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00000306

NIDA-09262-3

P50-09262-3

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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