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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA036553 | 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 initial efficacy of phendimetrazine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects will be maintained on oral placebo, administered twice daily for approximately two weeks. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. |
|
| Phendimetrazine | Experimental | Subjects will be maintained on oral phendimetrazine (up to 210 mg/day) administered twice daily for approximately two weeks. 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 |
|---|---|---|---|---|
| Phendimetrazine | Drug | Phendimetrazine will be administered in divided doses twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | The reinforcing effects of cocaine were determined using a modified progressive ratio procedure in which subjects made 10 choices between a portion of each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both phendimetrazine and placebo maintenance. | After at least seven days of maintenance placebo or target phendimetrazine dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky Department of Behavioral Science | Lexington | Kentucky | 40536-0086 | United States |
Thirty subjects were enrolled, but one was removed from the study due to an adverse event, leading to 29 completers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First, Then Phendimetrazine | Subjects were maintained on placebo for approximately 2 weeks, then they were crossed over to 210 mg phendimetrazine daily for approximately 2 weeks. |
| FG001 | Phendimetrazine First, Then Placebo | Subjects were maintained on 210 mg phendimetrazine for approximately 2 weeks, then they were crossed over to placebo daily for approximately 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Completers | Baseline demographics for study completers |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | The reinforcing effects of cocaine were determined using a modified progressive ratio procedure in which subjects made 10 choices between a portion of each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both phendimetrazine and placebo maintenance. | Posted | Mean | Standard Error | Cocaine Choices | After at least seven days of maintenance placebo or target phendimetrazine dose |
|
Approximately 1 month of inpatient admission
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Subjects were maintained on placebo for approximately 2 weeks. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William W. Stoops | University of Kentucky | 859-257-5388 | william.stoops@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2015 | May 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C100294 | phendimetrazine |
| D003042 | Cocaine |
| ID | Term |
|---|---|
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
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| Cocaine | Drug | Intranasal cocaine will be administered during experimental sessions. |
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| Placebo | Drug | Placebo capsules will contain only cornstarch. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Phendimetrazine | Subjects were maintained on 210 mg phendimetrazine for approximately 2 weeks. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |