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| ID | Type | Description | Link |
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| K01DA056692 | 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 outpatient study examines how cannabidiol (CBD) affects the behavioral and pain-relieving effects of cannabis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo CBD/Placebo Inhaled Cannabis | Placebo Comparator | Participants will receive non-therapeutic, experimental doses of placebo/inactive cannabidiol in combination with non-therapeutic, placebo/inactive vaporized marijuana. Inactive cannabidiol and inactive marijuana will be administered once per session. It is possible to receive both inactive drugs on the same day. Inactive/Placebo Cannabidiol: Placebo/inactive cannabidiol will be administered orally. Inactive/Placebo: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer. |
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| Placebo CBD/Active Inhaled Cannabis | Experimental | Participants will receive a non-therapeutic, experimental dose of inactive/placebo cannabidiol in combination with non-therapeutic, active vaporized marijuana. It is possible to receive inactive cannabidiol and active marijuana on the same day. Inactive/Placebo Cannabidiol: Active cannabidiol will be administered orally. Active Marijuana: Experimental, non-therapeutic administration of an active marijuana dose will be administered through a vaporizer. |
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| CBD (Medium Dose)/Placebo Inhaled Cannabis | Experimental | Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day. Active Cannabidiol: Active cannabidiol will be administered orally. Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol, Medium Dose | Drug | Active Cannabidiol: Active cannabidiol (medium dose) will be administered orally for 14 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline-Subject-Related Outcome-VAS Drug Liking | Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). These Scores will indicate how participants are feeling at that moment, including questions on mood, physical symptoms, and drug effects. Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores. | Days 1 (baseline), 7, 14, prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session). |
| Change from Baseline-Marijuana Purchase Task: Elasticity | Behavioral economic demand for cannabis: how much a participant values cannabis as its "price" (cost, effort, or availability) increases. Participants indicate how much marijuana they would buy and consume at increasing, hypothetical prices. This outcome describes how sensitive marijuana consumption is to price changes and how quickly demand decreases as marijuana becomes more expensive. | Days 1 (baseline), 7, 14, measured ~3 hours post cannabis administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline-Cold Pressor Test (CPT) Threshold | Participants first immerse a dominant hand into the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominanat hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Latency (in seconds) to first pain sensations (threshold) will be measured and recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul A Nuzzo, M.A. | Contact | 859-323-0002 | pnuzz2@email.uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hannah M Harris, Ph.D. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40508 | United States |
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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 |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| CBD (Medium Dose)/Active Inhaled Cannabis | Experimental | Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with non-therapeutic, experimental doses of active vaporized marijuana. Cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Vaporized Marijuana: Active Marijuana administered through a vaporizer Cannabidiol: Active cannabidiol will be administered orally |
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| CBD (Higher Dose)/Placebo Inhaled Cannabis | Experimental | Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day. Active Cannabidiol: Active cannabidiol will be administered orally. Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer. |
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| CBD (Higher Dose)/Active Inhaled Cannabis | Experimental | Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with a non-therapeutic, experimental dose of active vaporized marijuana. Active cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Active Cannabidiol: Active cannabidiol will be administered orally. Active Marijuana: Active Marijuana will be administered through a vaporizer. |
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| Cannabidiol, Higher Dose | Drug | Description: Active Cannabidiol: Active cannabidiol (higher dose) will be administered orally for 14 days. |
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| Active Inhaled Cannabis | Drug | Active Marijuana: Active Marijuana (active inhaled cannabis) will be administered through a vaporizer once per study session day (Day 1, 7, 14) per block (3 blocks total). |
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| Placebo Cannabidiol | Drug | Inactive/Placebo Cannabidiol: Inactive/placebo cannabidiol will be administered orally for 14 days. |
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| Placebo Inhaled Cannabis | Drug | Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer at each study session day (Days 1, 7, 14) per block (3 blocks total). |
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| Days 1 (baseline), 7, 14, This outcome will be recorded before and at two additional intervals after active and placebo cannabis administration during the laboratory session (a total of 6 measurements per session). |
| Change from Baseline-Cold Pressor Test (CPT) Tolerance | Participants first immerse a dominant hand into the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominant hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Latency to withdrawal from the water (tolerance) will be measured and recorded. | Days 1 (baseline), 7, 14, This outcome will be recorded before and at two additional intervals after active and placebo cannabis administration during the laboratory session (a total of 6 measurements per session). |
| Change from Baseline-Cold Pressor Visual Analog Scale (CPT-VAS): Painful | Participants first immerse a dominant hand in the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominant hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Participants will report how painful the pain was on a visual analog scale. Low scores mean little to no pain. Higher scores mean greater pain. Raw data transformed to peak scores. | Days 1 (baseline), 7, 14, This outcome will be recorded before and after the CPT for a total of 6 measurements per session. |