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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA047368 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The objective of this protocol is to use probabilistic reinforcement learning choice tasks and magnetic resonance neuroimaging to demonstrate the impact of problematic opioid use and opioid withdrawal on dynamic decision-making and reveal the neurobehavioral and neurobiological processes underlying abnormal task performance. A second objective is to identify an appropriate dose of intravenous remifentanil for subsequent studies in physically dependent individuals with opioid use disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone | Experimental | Subjects complete a probabilistic money-vs-money choice task during oxycodone maintenance. |
|
| Withdrawal | Experimental | Subjects complete a probabilistic money-vs-money choice task during opioid withdrawal induced via double-blind substitution of placebo for active oxycodone in maintenance capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | Participants receive oxycodone or placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Probabilistic Money vs Money Choice Task | Subjects completed a 300-trial probabilistic concurrent monetary choice task, also known as an n-bandit task (here, n=2 choice options, with unsigned probability reversals every 50 trials). In each trial, subjects chose between two options signaled by blue and green envelopes. When a reward was scheduled for the chosen option, subjects were notified they earned $0.25 USD; task earnings were provided upon session completion. Choice of the high probability option was more likely to be reinforced than the low probability option at a 6:1 ratio, with probabilities summing to 0.3, resulting in a low reinforcement density context. Because choosing the higher probability option is associated with a higher likelihood of receiving a monetary reinforcer, making more high probability choices is considered better performance on the task. | Subjects complete the task twice; once under opioid maintained and once under opioid withdrawn conditions during a 16-day inpatient participation. The task takes approximately 20 minutes to complete each time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JOSHUA 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 | Active Oxycodone and Placebo | Participants complete a probabilistic money-vs-money choice task during opioid maintained and opioid withdrawn conditions. Opioid withdrawal is accomplished via double-blind substitution of placebo for active oxycodone in daily maintenance capsules. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Oxycodone and Placebo | Participants complete a probabilistic money-vs-money choice task during opioid maintained and opioid withdrawn conditions. Opioid withdrawal is accomplished via double-blind substitution of placebo for active oxycodone in daily maintenance capsules. |
| 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 | Probabilistic Money vs Money Choice Task | Subjects completed a 300-trial probabilistic concurrent monetary choice task, also known as an n-bandit task (here, n=2 choice options, with unsigned probability reversals every 50 trials). In each trial, subjects chose between two options signaled by blue and green envelopes. When a reward was scheduled for the chosen option, subjects were notified they earned $0.25 USD; task earnings were provided upon session completion. Choice of the high probability option was more likely to be reinforced than the low probability option at a 6:1 ratio, with probabilities summing to 0.3, resulting in a low reinforcement density context. Because choosing the higher probability option is associated with a higher likelihood of receiving a monetary reinforcer, making more high probability choices is considered better performance on the task. | Posted | Mean | Standard Deviation | Number high probability option choices | Subjects complete the task twice; once under opioid maintained and once under opioid withdrawn conditions during a 16-day inpatient participation. The task takes approximately 20 minutes to complete each time. |
|
On each of the two days that choice task data were collected.
Udvalg for Kliniske Undersøgelser Side Effect Rating Scale Clinical Opiate Withdrawal Scale
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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 | Oxycodone | Subjects complete a probabilistic money-vs-money choice task during oxycodone maintenance. Oxycodone: Participants receive oxycodone or placebo. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated heart rate (>100 bpm) | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joshua Lile | University of Kentucky | 859-323-6034 | jalile2@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 | Dec 3, 2025 | Jun 29, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 29, 2025 | Oct 13, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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Within-subjects design
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Double-blind
| 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 |
|
| OG000 | Oxycodone | Subjects complete a probabilistic money-vs-money choice task during oxycodone maintenance. Oxycodone: Participants receive oxycodone or placebo. |
| OG001 | Withdrawal | Subjects complete a probabilistic money-vs-money choice task during opioid withdrawal induced via double-blind substitution of placebo for active oxycodone in maintenance capsules. Oxycodone: Participants receive oxycodone or placebo. |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 8 |
| 12 |
| EG001 | Withdrawal | Subjects complete a probabilistic money-vs-money choice task during opioid withdrawal induced via double-blind substitution of placebo for active oxycodone in maintenance capsules. Oxycodone: Participants receive oxycodone or placebo. | 0 | 12 | 0 | 12 | 11 | 12 |
| Sweating | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Restlessness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pupil dilation | Eye disorders | Systematic Assessment |
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| Bone and joint aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Runny nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Stomach cramps | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Tremor | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Yawning | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Piloerection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |