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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA016718 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study will examine the effects of doses of alcohol/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol | Experimental | Participants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session. |
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| Opioid Agonist | Experimental | Participants will receive non-therapeutic, experimental doses of an active opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered orally |
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| Opioid Agonist/Alcohol Combination | Experimental | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol | Drug | Active alcohol or placebo, administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | Participants rated their subjective drug liking on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater drug liking. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM). | These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel? | Participants rated their subjective response to the question "How drunk do you feel?" on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater feeling of drunk. TThis outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon L Walsh, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40508 | United States |
We have no plans to share individual participant data with other researchers.
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This is a crossover study with 9 conditions tested in random order in each completing subject.
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| ID | Title | Description |
|---|---|---|
| FG000 | The Behavioral Effects of Opioids and Alcohol | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||||||||
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| Overall Study |
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One participant did not complete the study. They left the study for non-study related reasons.
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcohol and Opioids | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking | Participants rated their subjective drug liking on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater drug liking. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM). | Per Protocol population, defined as participants completing the 9 experimental dosing conditions. | Posted | Mean | Standard Error | score on a scale | These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session) |
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Approximately 6 weeks. Adverse Event (AE) monitoring begins once consent is signed and is tracked through participant disqualification or follow-up visit.
AE definitions are the same as the clnicaltrials.gov definitions.
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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 | Pre-Intervention / Days Off | Prior to any drug administration or on participant days off when AE is not related to drug conditions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director for the Center on Drug and Alcohol Research | University of Kentucky | 859-257-6485 | Sharon.Walsh@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_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 2, 2025 | Oct 13, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
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This is a randomized, double-blind, double-dummy, placebo-controlled, within-subjects design
| Opioid Agonist | Drug | Active opioid agonist or placebo, administered orally |
|
| These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session) |
| Trough Oxygen Saturation | Oxygen saturation (measured as a percentage through pulse ox) monitored throughout each session. Lower scores indicate greater impairment. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' trough value was pulled from the raw data and averaged to yield one mean (SEM). | Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session). |
| Peak Cold Pressor Test Threshold | Participants immerse their forearm in cold water (1.0 +/- .5 degree Celsius) and remove their arm from the cold water to indicated pain tolerance (max 5 mins). Cold Pressor Test Threshold (time elapsed since cold water immersion measured in seconds) monitored throughout each session. Higher scores indicate greater impairment. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM). | Cold Pressor Test Threshold was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session). |
| 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 | Count of Participants | Participants |
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| OG001 | Oxycodone 20mg/Placebo | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally |
| OG002 | Oxycodone 40mg/Placebo | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally |
| OG003 | Placebo/Alcohol 0.5g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally |
| OG004 | Placebo/Alcohol 0.8g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally |
| OG005 | Oxycodone 20mg/Alcohol 0.5g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally |
| OG006 | Oxycodone 20mg/Alcohol 0.8g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally |
| OG007 | Oxycodone 40mg/Alcohol 0.5g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally |
| OG008 | Oxycodone 40mg/Alcohol 0.8g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally |
|
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| Secondary | Peak Subject-Rated Outcome: Visual Analog Scale (VAS) - How Drunk do You Feel? | Participants rated their subjective response to the question "How drunk do you feel?" on a standardized VAS scale (0 to 100; 0=Not at all, 100=Extremely). A higher score indicates greater feeling of drunk. TThis outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM). | Per Protocol population, defined as participants completing the 9 experimental dosing conditions. | Posted | Mean | Standard Error | score on a scale | These outcomes (visual analog scores, scale of 0-100) are recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session) |
|
|
|
| Secondary | Trough Oxygen Saturation | Oxygen saturation (measured as a percentage through pulse ox) monitored throughout each session. Lower scores indicate greater impairment. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' trough value was pulled from the raw data and averaged to yield one mean (SEM). | Per Protocol population, defined as participants completing the 9 experimental drug conditions. | Posted | Mean | Standard Error | Percentage of oxygen in blood | Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session). |
|
|
|
| Secondary | Peak Cold Pressor Test Threshold | Participants immerse their forearm in cold water (1.0 +/- .5 degree Celsius) and remove their arm from the cold water to indicated pain tolerance (max 5 mins). Cold Pressor Test Threshold (time elapsed since cold water immersion measured in seconds) monitored throughout each session. Higher scores indicate greater impairment. This outcome was recorded multiple times at regular intervals throughout the experimental dose condition sessions. For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM). | Per Protocol population, defined as participants completing the 9 experimental drug conditions. | Posted | Mean | Standard Error | Seconds | Cold Pressor Test Threshold was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session). |
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| 0 |
| 11 |
| 0 |
| 11 |
| 4 |
| 11 |
| EG001 | Qualification: Oxycodone 30mg / Placebo | Prior to the experimental conditions, participants will receive a non-therapeutic dose of oxycodone 30 mg, p.o. during a qualifying day session. This session serves as a responsive challenge which is intended to confirm that subjects are able to detect the active drug. | 0 | 11 | 0 | 11 | 2 | 11 |
| EG002 | Placebo/Placebo | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | 10 | 0 | 10 | 1 | 10 |
| EG003 | Oxycodone 20mg/Placebo | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | 11 | 0 | 11 | 0 | 11 |
| EG004 | Oxycodone 40mg/Placebo | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | 10 | 0 | 10 | 1 | 10 |
| EG005 | Placebo/Alcohol 0.5g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | 10 | 0 | 10 | 1 | 10 |
| EG006 | Placebo/Alcohol 0.8g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | 10 | 0 | 10 | 1 | 10 |
| EG007 | Oxycodone 20mg/Alcohol 0.5g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | 10 | 0 | 10 | 0 | 10 |
| EG008 | Oxycodone 20mg/Alcohol 0.8g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | 11 | 0 | 11 | 0 | 11 |
| EG009 | Oxycodone 40mg/Alcohol 0.5g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | 10 | 0 | 10 | 0 | 10 |
| EG010 | Oxycodone 40mg/Alcohol 0.8g/kg | Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol/placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally. Alcohol: Active alcohol or placebo, administered orally Opioid Agonist: Active opioid agonist or placebo, administered orally | 0 | 10 | 0 | 10 | 0 | 10 |
| Ear Pain | Ear and labyrinth disorders | Systematic Assessment |
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| Generalized Body Aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Nausea / Vomitting | Gastrointestinal disorders | Systematic Assessment |
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| Sinus Symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tooth Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| D045505 |
| Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |