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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA032254 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and phentermine during placebo maintenance. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. |
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| Topiramate Dose 1 | Experimental | Subjects will be maintained on the low topiramate dose. Subjects will be maintained on placebo and phentermine during maintenance on the low dose of topiramate. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. |
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| Topiramate Dose 2 | Experimental | Subjects will be maintained on the high topiramate dose. Subjects will be maintained on placebo and phentermine during maintenance on the high dose of topiramate. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cocaine | Drug | The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate. |
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| Measure | Description | Time Frame |
|---|---|---|
| Reinforcing Effects | The reinforcing effects of cocaine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses. | Nine times over approximately five weeks inpatient admission. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective effects | Subjects will complete subjective effects measures during nine sessions while they are admitted to our inpatient unit. These items will ask about drug effects and general mood. | Nine times over approximately five weeks inpatient admission. |
| Physiological Effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig R Rush, Ph.D. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
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| ID | Term |
|---|---|
| D003042 | Cocaine |
| D010645 | Phentermine |
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate. |
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| Phentermine | Drug | The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate. |
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| Topiramate | Drug | The pharmacodynamic effects of chronic topiramate will be determined. |
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Physiological measures will be completed daily while subjects are admitted to our inpatient unit. Physiological measures include temperature, heart rate and blood pressure. |
| Daily over approximately five week inpatient admissions |
| Side effects | Subjects will complete a side effects questionnaire daily while they reside on the inpatient unit. Side Effects questions will query subjects about common effects of centrally active medications. | Daily over approximately five weeks of inpatient admission |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 | Ketoses |