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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The research proposed in this application will determine the initial efficacy, safety and tolerability of a novel drug combination, oxazepam (Serax®) and naltrexone (Revia®), as a pharmacotherapy for methamphetamine (Desoxyn®) dependence. A rigorous, inpatient human laboratory study will be conducted. The proposed study is innovative and important because it will provide the impetus for the conduct of double blind, placebo-controlled trials to further demonstrate the efficacy of combined oxazepam and naltrexone for managing methamphetamine dependence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator | Subjects will be maintained on oral placebo. |
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| Arm 2 | Experimental | Subjects will be maintained on oral oxazepam (Serax®). |
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| Arm 3 | Experimental | Subjects will be maintained on oral naltrexone (Revia®). |
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| Arm 4 | Experimental | Subjects will be maintained on oral naltrexone (Revia®) and oral oxazepam (Serax®). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methamphetamine (Desoxyn®) | Drug | The pharmacodynamic effects of methamphetamine (Desoxyn®) will be determined during placebo, oxazepam (Serax®), naltrexone (Revia®) and combined oxazepam and naltrexone maintenance. |
| Measure | Description | Time Frame |
|---|---|---|
| Reinforcing Effects | The reinforcing effects of methamphetamine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo, oxazepam (Serax®), naltrexone (Revia®), and oxazepam and naltrexone combined. | After at least four days of placebo, oxazepam (Serax®), naltrexone (Revia®) or oxazepam and naltrexone maintenance |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Effects | Subjects will complete subjective effects measures during six sessions while they are admitted to our inpatient unit. These items will ask about drug effects and general mood. | 12 sessions over approximately 4 week inpatient admissions |
| Physiological and Side Effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
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| ID | Term |
|---|---|
| D008694 | Methamphetamine |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 |
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Physiological and side effects measures will be completed daily while subjects are admitted to our inpatient unit. Physiological measures include heart rate and blood pressure. Side Effects questions will query subjects about common effects of centrally active medications. |
| Daily over approximately 4 week inpatient admissions |
| Organic Chemicals |