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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA047368 | U.S. NIH Grant/Contract | View source |
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Funding ended
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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 choice tasks to determine the impact of withdrawal and drug cues on decision-making in individuals with opioid use disorder and physical opioid dependence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probabilistic Choice Task | Experimental | Subjects with opioid use disorder complete a probabilistic concurrent choice task under opioid maintained and withdrawn conditions. Three sessions include a money-vs-money task and three sessions include a drug-vs-money task. Monetary reward value is $0.25 or $4.00. Task option visual cues for the money-vs-money versions are colored envelopes or opioid-associated and matched neutral cues. Drug is an active dose of remifentanil. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug Cue | Behavioral | Individualized drug cues paired with choice options reinforced by $0.25 |
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| Measure | Description | Time Frame |
|---|---|---|
| Task Choices | Proportion of high probability choices. Subjects can choose between two options, one of which is rewarded at a higher probability than the other at a ratio of 6:1. The number of trials varied, so a proportion of total trials is reported. | Tasks will take approximately 45-60 minutes to complete. Participants will complete 6 sessions in which a choice task will be administered. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Probabilistic Choice Task | Subjects with opioid use disorder complete a probabilistic concurrent choice task under opioid maintained and withdrawn conditions. Three sessions include a money-vs-money task and three sessions include a drug-vs-money task. Monetary reward value is $0.25 or $4.00. Task option visual cues for the money-vs-money versions are colored envelopes or opioid-associated and matched neutral cues. Drug is an active dose of remifentanil. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Money-vs-money Opioid Maintained |
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| Money-vs-money Opioid Withdrawn |
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| Money-vs-money Maintained Drug Cues |
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| Drug-vs-low Money Opioid Maintained |
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| Drug-vs-low Money Opioid Withdrawn |
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| Drug-vs-large Money Opioid Maintained |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Probabilistic Choice Task | Subjects with opioid use disorder complete a probabilistic concurrent choice task under opioid maintained and withdrawn conditions. Three sessions include a money-vs-money task and three sessions include a drug-vs-money task. Monetary reward value is $0.25 or $4.00. Task option visual cues for the money-vs-money versions are colored envelopes or opioid-associated and matched neutral cues. Drug is an active dose of remifentanil. Drug Cue: Individualized drug cues paired with choice options reinforced by $0.25 Money: Two money values will be tested ($0.25 and $4.00) Withdrawal: Participants will be maintained on an opioid agonist. Placebo will be substituted to produce mild-to-moderate withdrawal. Remifentanil: IV remifentanil will be made available as one of the choice options in some 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 | Task Choices | Proportion of high probability choices. Subjects can choose between two options, one of which is rewarded at a higher probability than the other at a ratio of 6:1. The number of trials varied, so a proportion of total trials is reported. | Posted | Mean | Standard Deviation | proportion of high probability choices | Tasks will take approximately 45-60 minutes to complete. Participants will complete 6 sessions in which a choice task will be administered. |
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Throughout the 17-day inpatient protocol duration.
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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 | Neutral Cued Money-vs-Money Task Opioid Maintained | Subjects with opioid use disorder complete a probabilistic concurrent choice task. This session used a money-vs-money task. Monetary reward value is $0.25. Visual cues for the task are colored envelopes. Subjects are maintained on active hydromorphone. |
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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 | |
|---|---|---|---|---|
| Joshua Lile, PhD | 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 | Nov 14, 2024 | Mar 3, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 18, 2025 | Nov 30, 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 |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Money | Behavioral | Two money values will be tested ($0.25 and $4.00) |
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| Withdrawal | Drug | Participants will be maintained on an opioid agonist. Placebo will be substituted to produce mild-to-moderate withdrawal. |
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| Remifentanil | Drug | IV remifentanil will be made available as one of the choice options in some sessions. |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 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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|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Neutral Cued Money-vs-Money Task Opioid Withdrawn | Subjects with opioid use disorder complete a probabilistic concurrent choice task. This session used a money-vs-money task. Monetary reward value is $0.25. Visual cues for the task are colored envelopes. Subjects experience mild-to-moderate withdrawal associated with double-blind substitution of placebo for active hydromorphone maintenance capsules. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG002 | Opioid Cued Money-vs-Money Task Opioid Maintained | Subjects with opioid use disorder complete a probabilistic concurrent choice task. This session used a money-vs-money task. Monetary reward value is $0.25. Visual cues for the task are images of opioid drug and paraphernalia and matched neutral images. Subjects are maintained on active hydromorphone. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG003 | Drug-vs-Low Money Task Opioid Maintained | Subjects with opioid use disorder complete a probabilistic concurrent choice task. This session used a drug-vs-money task. Monetary reward value is $0.25. Subjects are maintained on active hydromorphone. The drug option is active remifentanil. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG004 | Drug-vs-High Money Task Opioid Maintained | Subjects with opioid use disorder complete a probabilistic concurrent choice task. This session used a drug-vs-money task. Monetary reward value is $4.00. Subjects are maintained on active hydromorphone. The drug option is active remifentanil. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG005 | Drug-vs-Low Money Task Opioid Withdrawn | Subjects with opioid use disorder complete a probabilistic concurrent choice task. This session used a drug-vs-money task. Monetary reward value is $0.25. The drug option is active remifentanil. Subjects experience mild-to-moderate withdrawal associated with double-blind substitution of placebo for active hydromorphone maintenance capsules. | 0 | 2 | 0 | 2 | 2 | 2 |
| 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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| Lacrimation | Eye disorders | Systematic Assessment |
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| Runny nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Stomach cramps | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Tremor | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Anxiety or Irritability | Psychiatric disorders | Systematic Assessment |
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| Respiration rate low | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| oxygen saturation low | Blood and lymphatic system disorders | Systematic Assessment |
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| blood pressure out of range | Cardiac disorders | Systematic Assessment |
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| heart rate out of range | Cardiac disorders | Systematic Assessment |
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| Irritation at catheter site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Superficial thrombus | Blood and lymphatic system disorders | Systematic Assessment |
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| End Tidal CO2 out of range | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |