This study will evaluate the pharmacokinetic and pharmacodynamic effects of hemp-based Cannabidiol (CBD) topical products (e.g., lotions, creams, patches) that contain low levels of delta-9-tetrahydrocannabinol (THC).
A total of 5 topical cannabinoid products will be examined in this study. The study will be conducted in 5 discrete stages, one for each product. In each stage, participants (N=20), will be randomized to 1 of 2 double-blind drug conditions that entail the use of: 1) a topical product that contains CBD and a low amount of THC (N=15), or 2) a placebo topical product that does not contain cannabinoids (N=5), but which contains similar non-cannabinoid ingredients to the active product. Thus, overall 100 participants will complete the study (75 active, 25 placebo). Participants in each stage will complete a three-phase outpatient protocol that will last a total of 17 days. Phase 1 (Day 1) will be an acute laboratory dosing session (approximately 7 hours in duration). Phase 2 (Days 2-10) will be an outpatient dosing period, during which participants will continue to use participants' assigned product twice daily (morning and evening) in participants' own environment. During Phase 2, participants will visit the laboratory for brief study sessions on Days 2, 3, 7, and 10. Phase 3, will consist of a final follow-up visit on Day 17, after a 1-week drug washout. Pharmacokinetic and pharmacodynamic assessments (subjective and cognitive effects) will be assessed during each phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
47
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States
Change in Urine cannabinoids
Concentration of cannabinoids will be measured in urine (unit of measurement: nanograms/mL)
Time frame: Days 1, 2, 3, 7, 10, and 17
Change in Blood cannabinoids
Concentration of cannabinoids will be measured in blood (unit of measurement: nanograms/mL)
Time frame: Days 1, 2, 3, 7, 10, and 17
Change in Oral fluid cannabinoids
Concentration of cannabinoids will be measured in oral fluid (unit of measurement: nanograms/mL)
Time frame: Days 1, 2, 3, 7, 10, and 17
Change in Hair cannabinoids
Concentration of cannabinoids will be measured in hair (unit of measurement: nanograms/mL)
Time frame: Days 1 and 17
Change in 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: Days 1, 2, 3, 7, 10, and 17
Change in Cognitive performance as assessed by the Divided Attention Task
Cognitive performance will be evaluated with the Divided Attention Task. Will be measured as the mean distance (in computer pixels) of the mouse cursor from the central stimulus.
Time frame: Days 1, 2, 3, 7, 10, and 17
Change in Working memory performance as assessed by the Paced Serial Addition Task
Working memory performance will be evaluated with the Paced Serial Addition Task (scores can range from 0-90) with 90 indicating perfect performance.
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Time frame: Days 1, 2, 3, 7, 10, and 17
Change in Psychomotor performance as assessed by the Digit Symbol Substitution Task
Psychomotor performance will be evaluated with the Digit Symbol Substitution Task. Will be measured as the number of correct trials within 90 seconds.
Time frame: Days 1, 2, 3, 7, 10, and 17