Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3

Study Overview
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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.

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.

Official Title
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Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients

Conditions
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Cocaine-Related Disorders, Opioid-Related Disorders

Intervention / Treatment
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* Drug: Dextroamphetamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dextroamphetamine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving |  |  | 
| Drug use |  |  | 
| Medication compliance |  |  | 
| Retention |  |  | 
| Addiction severity |  |  | 
| Mood indicators |  |  | 
| Psychiatric interview |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness measures including psycho-social variables, side effects, and self-reported measures. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cocaine dependence