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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 choice self-administration procedures between drug and a non-drug alternative reinforcer presented during maintenance on d-amphetamine, which has been previously shown to reduce cocaine use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental | Cocaine choice during d-amphetamine maintenance |
|
| Placebo Treatment | Placebo Comparator | Cocaine choice during placebo maintenance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cocaine | Drug |
| ||
| Sustained Release d-Amphetamine |
| 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 (Lile et al., 2016) in which subjects made 9 choices between each available cocaine dose and money (US$6.00). Reinforcing effects are measured for each cocaine dose during both d-amphetamine and placebo maintenance. | 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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| 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 | Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine | Cocaine choice during placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine maintenance Placebo and Cocaine Placebo and Sustained Release d-Amphetamine |
| FG001 | 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine | Cocaine choice during 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine maintenance Placebo and Cocaine Placebo Sustained Release d-Amphetamine maintenance |
| FG002 | 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo | Cocaine choice during 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo maintenance Placebo and Cocaine Placebo and Sustained Release d-Amphetamine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine | Cocaine choice during Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine maintenance Placebo and Cocaine Placebo and Sustained Release d-Amphetamine |
| BG001 | 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine |
| 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 (Lile et al., 2016) in which subjects made 9 choices between each available cocaine dose and money (US$6.00). Reinforcing effects are measured for each cocaine dose during both d-amphetamine and placebo maintenance. | Posted | Mean | Standard Error | cocaine choices | 9 choice trials per cocaine dose level with each trial separated by 30 minutes |
|
33 days per subject.
Adverse event reporting consists of each the duration of each d-amphetamine maintenance condition as well as during the conduct of a medical safety session in which cocaine doses are administered prior to initiation of d-amphetamine maintenance.
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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 | Medical Safety Session | Experimenter administered Placebo and Cocaine delivery. d-Amphetamine maintenance not yet initiated. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Chest pain after a session with placebo cocaine maintenance on 60 mg d-amphetamine. Cardiovascular monitoring revealed normal vital signs and heart rhythmicity. Pain determined to be musculoskeletal. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua A. Lile, Ph.D. | University of Kentucky | 859-420-0503 | jalile2@uky.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 17, 2017 | Feb 19, 2019 | Prot_000.pdf |
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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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| Drug |
|
|
Cocaine choice during 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine maintenance Placebo and Cocaine Placebo and Sustained Release d-Amphetamine |
| BG002 | 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo | Cocaine choice during 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo maintenance Placebo and Cocaine Placebo and Sustained Release d-Amphetamine |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Cocaine choice during placebo maintenance
Placebo and Cocaine
Placebo
| OG002 | 60 mg d-Amphetamine | Cocaine choice during 60 mg d-amphetamine maintenance Placebo and Cocaine Sustained Release d-Amphetamine |
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | Placebo | Cocaine choice during placebo d-Amphetamine maintenance Placebo and Cocaine | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | 30 mg d-Amphetamine | Cocaine choice during 30 mg d-Amphetamine maintenance Placebo and Cocaine | 0 | 17 | 0 | 17 | 0 | 17 |
| EG003 | 60 mg d-Amphetamine | Cocaine choice during 60 mg d-Amphetamine maintenance Placebo and Cocaine | 0 | 17 | 0 | 17 | 1 | 17 |
|
| Nausea and vomiting | Gastrointestinal disorders | Non-systematic Assessment | Nausea and vomiting after smoking a cigarette following administration of cocaine doses during the medical safety session. |
|
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| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |