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The study is to primarily measure safety and interactions between oral doses of Naltrexone/Bupropion and i.v. Methamphetamine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone and Bupropion SR | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Other | matching placebo |
| |
| Naltrexone and Bupropion SR |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular System Effects | Heart rate, blood pressure, ECGs,and monitoring adverse events | daily during the 10 day treatment period |
| Number of subjects with adverse events | Day 0 through Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations obtained at specific timepoints |
| daily during the 10 day treatment period |
| Assessment of Vital Signs and Clinical Chemistries |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Langley Porter Psychiatric Institute | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Drug |
25mg bid/day (NX) 200mg bid/day (BUP) |
|
Respiration rate and clinical laboratory measures |
| Daily during the 10 day treatment period |
| Cognitive Assessments as reported by the subject | Subject reported effects measured with VAS, BSCS, and POMS | Dailly during the 10 day treatment period |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |