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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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This study will examine the effects of doses of marijuana/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 |
|---|---|---|---|
| Vaporized Marijuana | Experimental | Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. |
|
| Opioid Agonist | Experimental | Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). |
|
| Opioid Agonist/Marijuana Combination | Experimental | Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. |
|
| Placebo | Placebo Comparator | Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaporized Marijuana | Drug | Active Marijuana administered through vaporizer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subject-Rated Outcome - VAS Drug Liking | Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores. | This outcome (visual analog scores, scale of 0-100) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Oxygen Saturation | Oxygen saturation (measured as a percentage) monitored throughout each session. Raw data transformed to trough scores. | Oxygen saturation was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals. |
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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 | 40508 | United States |
We have no plans to share individual participant data with other researchers.
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Unique, randomized dose orders were created for each participant. The study utilized a within-subject design.
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| ID | Title | Description |
|---|---|---|
| FG000 | Opioid and Cannabinoid Interactions | Within subject study. Participants will receive experimental/non-therapeutic doses of active/inactive marijuana in combination experimental/non-therapeutic dose of inactive/active opioids. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Per protocol population. Defined as participants completing the experimental drug conditions.
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| ID | Title | Description |
|---|---|---|
| BG000 | Opioid and Cannabinoid Interactions | Within subject study. Participants will receive experimental/non-therapeutic doses of active/inactive marijuana in combination experimental/non-therapeutic dose of inactive/active opioids. |
| 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 | Change in Subject-Rated Outcome - VAS Drug Liking | Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores. | Per Protocol population, defined as participants completing the experimental drug conditions. | Posted | Mean | Standard Error | score on a scale | This outcome (visual analog scores, scale of 0-100) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals. |
|
4 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 | Placebo/Placebo | Participants will receive non-therapeutic, experimental doses of placebo. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 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_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 22, 2025 | Feb 5, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
| D013759 | Dronabinol |
| D000701 | Analgesics, Opioid |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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This is a randomized, double-blind, double-dummy, placebo-controlled design
| Opioid Agonist | Drug | Active Opioid Agonist administered intranasally |
|
|
| Placebo | Drug | Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) |
|
| Change in Respiration Rate | Respiration rate (number of breaths per minute). Raw data transformed to trough scores. | Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals. |
| Change in Systolic Blood Pressure | Systolic blood pressure (mm Hg). Raw data transformed to peak scores. | Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals. |
| Change in Diastolic Blood Pressure | Diastolic blood pressure (mm Hg). Raw data transformed to peak scores. | Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | THC 10mg/Placebo Opioid | Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) |
| OG002 | THC 30mg/Placebo Opioid | Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) |
| OG003 | Oxycodone 15mg/Placebo Marijuana | Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). Opioid Agonist: Active Opioid Agonist administered intranasally Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) |
| OG004 | Oxycodone 30mg/Placebo Marijuana | Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). Opioid Agonist: Active Opioid Agonist administered intranasally Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) |
| OG005 | TCH 10mg/Oxycodone 15mg | Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally |
| OG006 | TCH 10mg/Oxycodone 30mg | Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally |
| OG007 | TCH 30mg/Oxycodone 15mg | Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally |
| OG008 | TCH 30mg/Oxycodone 30mg | Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally |
|
|
| Secondary | Change in Oxygen Saturation | Oxygen saturation (measured as a percentage) monitored throughout each session. Raw data transformed to trough scores. | Per Protocol population, defined as participants completing the experimental drug conditions. | Posted | Mean | Standard Error | percentage of oxygen saturation | Oxygen saturation was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals. |
|
|
|
| Secondary | Change in Respiration Rate | Respiration rate (number of breaths per minute). Raw data transformed to trough scores. | Per Protocol population, defined as participants completing the experimental drug conditions. | Posted | Mean | Standard Error | number of breaths per minute | Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals. |
|
|
|
| Secondary | Change in Systolic Blood Pressure | Systolic blood pressure (mm Hg). Raw data transformed to peak scores. | Per Protocol population, defined as participants completing the experimental drug conditions. | Posted | Mean | Standard Error | mm Hg | Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals. |
|
|
|
| Secondary | Change in Diastolic Blood Pressure | Diastolic blood pressure (mm Hg). Raw data transformed to peak scores. | Per Protocol population, defined as participants completing the experimental drug conditions. | Posted | Mean | Standard Error | mm Hg | Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals. |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 4 |
| 9 |
| EG001 | THC 10mg/Placebo Opioid | Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | THC 30mg/Placebo Opioid | Participants will receive non-therapeutic, experimental doses of active vaporized marijuana. Active marijuana will be administered once per session and will be administered via a vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) | 0 | 9 | 0 | 9 | 1 | 9 |
| EG003 | Oxycodone 15mg/Placebo Marijuana | Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). Opioid Agonist: Active Opioid Agonist administered intranasally Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) | 0 | 9 | 0 | 9 | 2 | 9 |
| EG004 | Oxycodone 30mg/Placebo Marijuana | Participants will receive non-therapeutic, experimental doses of an active opioid agonist. Active opioid agonist will be administered once per session and will be administered intranasally (snorting). Opioid Agonist: Active Opioid Agonist administered intranasally Placebo: Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s) | 0 | 9 | 0 | 9 | 2 | 9 |
| EG005 | TCH 10mg/Oxycodone 15mg | Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally | 0 | 9 | 0 | 9 | 0 | 9 |
| EG006 | TCH 10mg/Oxycodone 30mg | Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally | 0 | 9 | 0 | 9 | 3 | 9 |
| EG007 | TCH 30mg/Oxycodone 15mg | Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally | 0 | 9 | 0 | 9 | 2 | 9 |
| EG008 | TCH 30mg/Oxycodone 30mg | Participants will receive non-therapeutic, experimental doses of active opioid in combination with non-therapeutic, experimental doses of active vaporized marijuana. Opioid and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid doses will be administered intranasally; marijuana doses will be administered via vaporizer. Vaporized Marijuana: Active Marijuana administered through vaporizer Opioid Agonist: Active Opioid Agonist administered intranasally | 0 | 9 | 0 | 9 | 0 | 9 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dental Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Eye Dryness | Eye disorders | Systematic Assessment |
|
| Dry Nose | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Shoulder Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Body Aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D009294 |
| Narcotics |
| D002492 | Central Nervous System Depressants |
| 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 |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| 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 |