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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
75
Johns Hopkins University
Baltimore, Maryland, United States
Urine cannabinoids
Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL)
Time frame: Day 1, 2, 7, 14, and 21
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.
Time frame: Day 1
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 21
Blood cannabinoids
Concentration of cannabinoids will be measured in blood (unit of measurement: nanograms/mL)
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Time frame: Day 1, 2, 7, 14, and 21
Oral Fluid cannabinoids
Concentration of cannabinoids will be measured in oral fluid (unit of measurement: nanograms/mL)
Time frame: Day 1, 2, 7, 14, and 21