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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA045700 | 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 primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-blind marijuana/placebo administration | Experimental | Participants will receive double-blind administration of vaporized marijuana/placebo |
|
| Double-blind opioid/placebo administration | Experimental | Participants will receive double-blind administration of intranasal opioid agonist/placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marijuana | Drug | Double-blind administration of marijuana |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-Administration of Drug Units Earned | The number of units of drug (out of a total of 7) earned in each experimental condition. Participants work for some, none, or all of the available drug dose. For each dose condition, the number of drug units completed for drug was pulled from the raw data and averaged to yield one mean (SEM). | Through a progressive-ratio self-administration model given once per treatment condition throughout each 6 hour session |
| Measure | Description | Time Frame |
|---|---|---|
| Peak End-tidal Carbon Dioxide (EtCO2) | End-tidal Carbon Dioxide (EtCO2): For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM). Higher scores indicate greater impairment. | This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shanna Babalonis, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-blind Marijuana/Placebo & Opioid/Placebo Administration | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid agonist/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an intranasal opioid agonist/placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Per protocol population. Defined as participants that complete all 12 experimental conditions.
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-blind Marijuana/Placebo & Opioid/Placebo Administration | Participants will receive double-blind administration of vaporized marijuana/placebo and opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an intranasal opioid agonist/plcebo |
| 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 | Self-Administration of Drug Units Earned | The number of units of drug (out of a total of 7) earned in each experimental condition. Participants work for some, none, or all of the available drug dose. For each dose condition, the number of drug units completed for drug was pulled from the raw data and averaged to yield one mean (SEM). | Posted | Mean | Standard Error | Number of drug units | Through a progressive-ratio self-administration model given once per treatment condition throughout each 6 hour session |
|
7 weeks
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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 | Days prior to any drug administration or days between experimental conditions (days off). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stubbed toe | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shanna Babalonis, Ph.D. | University of Kentucky | 859-257-1881 | babalonis@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 12, 2025 | Feb 13, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2025 | Feb 12, 2026 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 12, 2025 | Nov 4, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000074609 | Marijuana Use |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Opioid | Drug | Double-blind administration of an opioid agonist |
|
| Trough Respiration Rate | Respiration rate (number of breaths per minute): For each dose condition, the participants' trough value was pulled from the raw data and averaged to yield one mean (SEM). Lower scores indicate greater impairment. | This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours). |
| 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 |
|
| Oxycodone 0mg / Self-Admin Dose: THC 10mg |
Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo |
| OG002 | Oxycodone 0mg / Self-Admin Dose: THC 30mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo |
| OG003 | Oxycodone 45mg / Self-Admin Dose: THC 0mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo |
| OG004 | Oxycodone 45mg / Self-Admin Dose: THC 10mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo |
| OG005 | Oxycodone 45mg / Self-Admin Dose: THC 30mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo |
| OG006 | THC 0mg / Self-Admin Dose: Oxycodone 0mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo |
| OG007 | THC 0mg / Self-Admin Dose: Oxycodone 15mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo |
| OG008 | THC 0mg / Self-Admin Dose: Oxycodone 45mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo |
| OG009 | THC 30mg / Self-Admin Dose: Oxycodone 0mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo |
| OG010 | THC 30mg / Self-Admin Dose: Oxycodone 15mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo |
| OG011 | THC 30mg / Self-Admin Dose: Oxycodone 45mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo |
|
|
| Secondary | Peak End-tidal Carbon Dioxide (EtCO2) | End-tidal Carbon Dioxide (EtCO2): For each dose condition, the participants' peak value was pulled from the raw data and averaged to yield one mean (SEM). Higher scores indicate greater impairment. | Per Protocol population, defined as participants completing the 12 experimental drug conditions. | Posted | Mean | Standard Error | units (mmHg) | This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours). |
|
|
|
| Secondary | Trough Respiration Rate | Respiration rate (number of breaths per minute): For each dose condition, the participants' trough value was pulled from the raw data and averaged to yield one mean (SEM). Lower scores indicate greater impairment. | Posted | Mean | Standard Error | breaths per minute | This outcome was recorded prior to and in regular intervals after drug administration for the duration of each session (approximately 6 hours). |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Oxycodone 0mg / Self-Admin Dose: THC 0mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | Oxycodone 0mg / Self-Admin Dose: THC 10mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Oxycodone 0mg / Self-Admin Dose: THC 30mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo | 0 | 7 | 0 | 7 | 0 | 7 |
| EG004 | Oxycodone 45mg / Self-Admin Dose: THC 0mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo | 0 | 7 | 0 | 7 | 0 | 7 |
| EG005 | Oxycodone 45mg / Self-Admin Dose: THC 10mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo | 0 | 6 | 0 | 6 | 1 | 6 |
| EG006 | Oxycodone 45mg / Self-Admin Dose: THC 30mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo | 0 | 6 | 0 | 6 | 1 | 6 |
| EG007 | THC 0mg / Self-Admin Dose: Oxycodone 0mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo | 0 | 6 | 0 | 6 | 0 | 6 |
| EG008 | THC 0mg / Self-Admin Dose: Oxycodone 15mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo | 0 | 6 | 0 | 6 | 0 | 6 |
| EG009 | THC 0mg / Self-Admin Dose: Oxycodone 45mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo | 0 | 6 | 0 | 6 | 0 | 6 |
| EG010 | THC 30mg / Self-Admin Dose: Oxycodone 0mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo | 0 | 6 | 0 | 6 | 0 | 6 |
| EG011 | THC 30mg / Self-Admin Dose: Oxycodone 15mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo | 0 | 6 | 0 | 6 | 1 | 6 |
| EG012 | THC 30mg / Self-Admin Dose: Oxycodone 45mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo Marijuana: Double-blind administration of marijuana/placebo Opioid: Double-blind administration of an opioid agonist/placebo | 0 | 6 | 0 | 6 | 1 | 6 |
| EG013 | Qualification Condition: THC 20mg / Oxycodone 0mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo prior to entering the experimental conditions of the study. Marijuana: Double-blind administration of marijuana Opioid: Double-blind administration of an opioid agonist 0mg (placebo) | 0 | 7 | 0 | 7 | 0 | 7 |
| EG014 | Qualification Condition: THC 0mg / Oxycodone 30mg | Participants will receive double-blind administration of vaporized marijuana/placebo and intranasal opioid/placebo prior to entering the experimental conditions of the study. Marijuana: Double-blind administration of marijuana 0mg (placebo) Opioid: Double-blind administration of an opioid agonist. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG015 | Sample Condition: THC 0mg | Participants will receive double-blind administration of vaporized marijuana 0mg (placebo) on a "sample" day. Sample test sessions occur on different days from the other experimental conditions. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG016 | Sample Condition: THC 10mg | Participants will receive double-blind administration of vaporized marijuana 10mg on a "sample" day. Sample test sessions occur on different days from the other experimental conditions. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG017 | Sample Condition: THC 30mg | Participants will receive double-blind administration of vaporized marijuana 30mg on a "sample" day. Sample test sessions occur on different days from the other experimental conditions. | 0 | 7 | 0 | 7 | 1 | 7 |
| EG018 | Sample Condition: Oxycodone 0mg | Participants will receive double-blind administration of intranasal oxycodone 0mg (placebo) on a "sample" day. Sample test sessions occur on different days from the other experimental conditions. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG019 | Sample Condition: Oxycodone 15mg | Participants will receive double-blind administration of intranasal oxycodone 15mg on a "sample" day. Sample test sessions occur on different days from the other experimental conditions. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG020 | Sample Condition: Oxycodone 45mg | Participants will receive double-blind administration of intranasal oxycodone 45mg on a "sample" day. Sample test sessions occur on different days from the other experimental conditions. | 0 | 6 | 0 | 6 | 1 | 6 |
| Right foot pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Itchiness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Stomach ache | Gastrointestinal disorders | Systematic Assessment |
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| Jaw/neck soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Vomitting / Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Atheletes foot | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |