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| Name | Class |
|---|---|
| Substance Abuse And Mental Health Administration | UNKNOWN |
| Canopy Growth Corporation | INDUSTRY |
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This study will evaluate the pharmacokinetic and pharmacodynamic effects of oral Cannabidiol (with or without low levels of THC), under acute and chronic dosing conditions.
Participants (N=60), will be randomized to 1 of 3 oral dosing conditions that include: 100mg CBD/3.7mg THC (0.39% THC), 100mg CBD/2.8mg THC (0.3% THC), or 100mg CBD/0mg THC (0.0% THC). Participants will first complete an 8-hour drug administration session and after this initial session, participants will take participants' assigned study drug for the next 14 days at home, twice daily (participants will visit the lab on days 2, 7, and 14). Participants will return on day 21 (after 1 week washout) for a final visit. During the 8-hour session and visits occurring during the following 21 days, participants will provide biospecimens (urine, blood, oral fluid, hair) which will be tested for cannabinoid concentrations. Pharmacodynamic assessments (subjective and cognitive effects) will also be assessed during these visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBD without THC | Experimental | oral formulation containing 100mg CBD and 0mg THC |
|
| CBD with 3.7 mg THC | Experimental | oral formulation containing 100mg CBD and 3.7mg THC |
|
| CBD with 2.8 mg THC | Experimental | oral formulation containing 100mg CBD and 2.8 mg THC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBD | Drug | CBD will be orally ingested |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine cannabinoids | Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL) | Day 1, 2, 7, 14, and 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective drug effects as assessed by the Drug Effect Questionnaire | Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect. | Day 1 |
| Subjective drug effects as assessed by the Drug Effect Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Vandrey, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21224 | 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 |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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Participants (N=60), will be randomized to 1 of 3 oral dosing conditions that include: 100mg CBD/3.7mg THC (0.39% THC), 100mg CBD/2.8mg THC (0.3% THC), or 100mg CBD/0mg THC (0.0% THC).
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dosing will be double-blind
| THC | Drug | THC will be orally ingested |
|
Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect. |
| Day 2 |
| Subjective drug effects as assessed by the Drug Effect Questionnaire | Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect. | Day 7 |
| Subjective drug effects as assessed by the Drug Effect Questionnaire | Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect. | Day 14 |
| Subjective drug effects as assessed by the Drug Effect Questionnaire | Subjective drug effect ratings (0-100) will be collected with the Drug Effect Questionnaire, with 0 being no effect and 100 being maximum effect. | Day 21 |
| Blood cannabinoids | Concentration of cannabinoids will be measured in blood (unit of measurement: nanograms/mL) | Day 1, 2, 7, 14, and 21 |
| Oral Fluid cannabinoids | Concentration of cannabinoids will be measured in oral fluid (unit of measurement: nanograms/mL) | Day 1, 2, 7, 14, and 21 |