Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DA045023 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
The objective of this protocol is to use a drug-vs-money choice task, reinforcement learning modeling and fMRI to determine the neurobehavioral and neurobiological decision-making "profile" associated with the decision to take cocaine and the reduced cocaine choice that occurs during a behavioral intervention (alternative money reinforcer) that models contingency management.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| $0.25 alternative reinforcer value | Experimental | Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and an alternative monetary reinforcer are available during each trial. Each money value is tested in a separate session. |
|
| $1.00 alternative reinforcer value | Experimental | Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and an alternative monetary reinforcer are available during each trial. Each money value is tested in a separate session. |
|
| $4.00 alternative reinforcer value | Experimental | Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and an alternative monetary reinforcer are available during each trial. Each money value is tested in a separate session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Money | Behavioral | Three money values offered as alternatives to cocaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | The reinforcing effects of cocaine are determined using a reinforcement learning choice task. Subjects complete trials in which they could possibly receive the available cocaine dose or money. Reinforcing effects are measured for a fixed cocaine dose when three amounts of money are available as alternatives to cocaine. Each money value is tested in a separate session. | Choices occur across a 40 minute session |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joshua Lile, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory of Human Behavioral Pharmacology | Lexington | Kentucky | 40536-0086 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
3 subjects were lost to follow up and 4 subjects were screen fails. All 8 subjects who were admitted to the inpatient unit completed the three within-subjects experimental conditions.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | The Impact of Alternative Reinforcer Magnitude on Cocaine vs Money Choice | Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and varying amounts of money ($0.25, 1.00, 4.00) are available during each trial. Money: Three money values offered as alternatives to cocaine. Cocaine HCl: 3 mg/70 kg is available as an alternative to money. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | The Effects of Alternative Reinforcer Magnitude on Cocaine vs Money Choice | Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and varying amounts of money ($0.25, 1.00, 4.00) are available during each trial. Money: Three money values offered as alternatives to cocaine. Cocaine HCl: 3 mg/70 kg is available as an alternative to money. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative | The reinforcing effects of cocaine are determined using a reinforcement learning choice task. Subjects complete trials in which they could possibly receive the available cocaine dose or money. Reinforcing effects are measured for a fixed cocaine dose when three amounts of money are available as alternatives to cocaine. Each money value is tested in a separate session. | People with cocaine use disorder | Posted | Mean | Standard Deviation | number of choices | Choices occur across a 40 minute session |
|
AEs were collected during the duration of data collection on three separate days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | $0.25 Alternative Reinforcer Value | Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and $0.25 are available during each trial. Money: Three money values offered as alternatives to cocaine. Cocaine HCl: 3 mg/70 kg is available as an alternative to money. This is a within-subjects study, but AE results are reported by each of the three experimental conditions (i.e., 3 separate alternative money conditions) that each subject completed on separate sessions. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Heart Rate | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Lile, Ph.D. | University of Kentucky | 859-323-6034 | jalile2@uky.edu |
Not provided
| 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 | Feb 11, 2025 | Mar 12, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003042 | Cocaine |
| ID | Term |
|---|---|
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
A placebo-controlled, randomized, within-subjects design will be used to assess cocaine-vs-money choice in cocaine use disordered subjects as a function of alternative reinforcer value.
Not provided
Not provided
Cocaine dose is administered under double-blind conditions. Available money value is not masked.
| Cocaine HCl | Drug | 3 mg/70 kg is available as an alternative to money. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | $1.00 Alternative Reinforcer Value | Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and $1.00 are available during each trial. Money: Three money values offered as alternatives to cocaine. Cocaine HCl: 3 mg/70 kg is available as an alternative to money. |
| OG002 | $4.00 Alternative Reinforcer Value | Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and $4.00 are available during each trial. Money: Three money values offered as alternatives to cocaine. Cocaine HCl: 3 mg/70 kg is available as an alternative to money. |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 3 |
| 8 |
| EG001 | $1.00 Alternative Reinforcer Value | Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and $1.00 are available during each trial. Money: Three money values offered as alternatives to cocaine. Cocaine HCl: 3 mg/70 kg is available as an alternative to money. This is a within-subjects study, but AE results are reported by each of the three experimental conditions (i.e., 3 separate alternative money conditions) that each subject completed on separate sessions. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG002 | $4.00 Alternative Reinforcer Value | Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and $4.00 are available during each trial. Money: Three money values offered as alternatives to cocaine. Cocaine HCl: 3 mg/70 kg is available as an alternative to money. This is a within-subjects study, but AE results are reported by each of the three experimental conditions (i.e., 3 separate alternative money conditions) that each subject completed on separate sessions. | 0 | 8 | 0 | 8 | 1 | 8 |
| Elevated Blood Pressure | Cardiac disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |