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Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate self-administration procedures and a non-drug alternative reinforcer, which is hypothesized to reduce the reinforcing effects of cocaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Value Alternative Reinforcer | Experimental | A low value reinforcer will be made available as an alternative to cocaine and placebo. |
|
| Medium Value Reinforcer | Experimental | A medium value reinforcer will be made available as an alternative to cocaine and placebo. |
|
| High Value Reinforcer | Experimental | A high value reinforcer will be made available as an alternative to cocaine and placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cocaine | Drug | Three active doses of cocaine will be made available for self-administration during experimental sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The 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 9 choices between each available cocaine dose and one of three money alternatives. | 9 choice trials per cocaine dose level with each trial separated by 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua A Lile, Ph.D | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Human Behavioral Pharmacology | Lexington | Kentucky | 40536-0086 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized Combination of One Drug Dose and One Money Value | Low, medium and high value monetary reinforcers are made available as an alternative to cocaine and placebo during experimental sessions. Cocaine: Three active doses of cocaine are made available for self-administration during experimental sessions. Placebo: Placebo cocaine is made available for self-administration during experimental sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized Combination of One Drug Dose and One Money Value | Low, medium and high value monetary reinforcers are made available as an alternative to cocaine and placebo during experimental sessions. Cocaine: Three active doses of cocaine are made available for self-administration during experimental sessions. Placebo: Placebo cocaine is made available for self-administration during experimental sessions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The 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 9 choices between each available cocaine dose and one of three money alternatives. | Posted | Mean | Standard Error | cocaine choices | 9 choice trials per cocaine dose level with each trial separated by 30 minutes |
|
15 days per subject.
Adverse event reporting consists of each experimental session in which a single cocaine dose and monetary reinforcer were available as choice alternatives, as well as during the conduct of a medical safety session in which cocaine doses are administered prior to choice sessions.
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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 | Randomized Combination of One Drug Dose and One Money Value | Low, medium and high value monetary reinforcers are made available as an alternative to cocaine and placebo during experimental sessions. Cocaine: Three active doses of cocaine are made available for self-administration during experimental sessions. Placebo: Placebo cocaine is made available for self-administration during experimental sessions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and vomiting | Gastrointestinal disorders | Non-systematic Assessment | Three incidents of nausea and vomiting that did not coincide with drug administration. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua A. Lile, Ph.D. | University of Kentucky | 859-420-0503 | jalile2@uky.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003042 | Cocaine |
| ID | Term |
|---|---|
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo cocaine will be made available for self-administration during experimental sessions. |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
A medium value reinforcer was made available as an alternative to cocaine and placebo. Cocaine: Three active doses of cocaine will be made available for self-administration during experimental sessions. Placebo: Placebo cocaine will be made available for self-administration during experimental sessions. |
| OG002 | High Value Reinforcer | A high value reinforcer was made available as an alternative to cocaine and placebo. Cocaine: Three active doses of cocaine will be made available for self-administration during experimental sessions. Placebo: Placebo cocaine will be made available for self-administration during experimental sessions. |
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| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
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| Difficulty obtaining IV line | Investigations | Non-systematic Assessment | Multiple sticks required to place IV catheter |
|
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| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |