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| ID | Type | Description | Link |
|---|---|---|---|
| P50-09262-3 |
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| Name | Class |
|---|---|
| University of Texas | OTHER |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextroamphetamine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Craving | ||
| Drug use | ||
| Medication compliance | ||
| Retention | ||
| Addiction severity | ||
| Mood indicators | ||
| Psychiatric interview |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness measures including psycho-social variables, side effects, and self-reported measures. |
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Inclusion Criteria- Subject must:
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
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| Name | Affiliation | Role |
|---|---|---|
| John Grabowski, Ph.D. | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center | Houston | Texas | 77225 | United States |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
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| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| ID | Term |
|---|---|
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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| D000588 |
| Amines |
| D009930 | Organic Chemicals |