Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Healthy
Type
Interventional
Phase
Early Phase 1
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Each participant will receive a different dose in consecutive weeks (4 doses total, one of which is a placebo), thus serving as their own control.Masking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 35 years
Gender
Both males and females

Description

The study will be conducted in the Exercise Physiology Laboratory in the Jeffords Science Building at Castleton University. Participants will be asked to fast overnight, avoid beverages or food containing caffeine, alcohol, or CBD for at least 12h, and to not perform physical effort for 6h prior to ...

The study will be conducted in the Exercise Physiology Laboratory in the Jeffords Science Building at Castleton University. Participants will be asked to fast overnight, avoid beverages or food containing caffeine, alcohol, or CBD for at least 12h, and to not perform physical effort for 6h prior to each session. During the initial session, individuals will: have their height and body mass measured, complete a health history questionnaire, and sign a consent form approved by Castleton University's Institutional Review Board. Prior to data collection, individuals will be advised of the possible risks, methods, and potential benefits of this study. They will also be familiarized with the noninvasive cardiovascular monitoring equipment, which they will be putting on themselves. These include an automated blood pressure (BP) cuff and a heart rate (HR) chest strap monitor. On the day of each experiment, participants will be given a standardized meal and asked to put on the BP cuff and HR monitor. Individuals will remain seated for the length of the experiment (doing nothing or reading). Baseline measurements will be taken remotely following 15 minutes of rest. Under supervision, participants will be asked to consume oral CBD oil (0mg, 25 mg, 50 mg, or 200mg), infused in non-CBD containing MCT (medium-chain triglycerides) oil to standardize dose volume of 3ml. Assessments will be measured remotely at intervals up to 2.5 hours after ingestion. The study will be double-blind, thus neither the participant nor researcher will be aware of the CBD dose for a particular session. Participants will be asked to return for 3 additional consecutive weeks, each session will be a different dose of CBD. In the final experimental session (to be completed after initial analyses of dose responses), participants will be given a standardized meal and asked to put on the blood pressure cuff and HR monitors. Individuals will remain seated for the length of the experiment. Following 15 minutes of rest, participants will be asked to perform two autonomic stress tests: the isometric hand grip test, and the cold face test. First, the maximum voluntary contraction (MVC) for the isometric hand grip test will be assessed. Participants will be asked to press a handgrip dynamometer with full strength. To perform the isometric handgrip test, participants will again use the dynamometer and maintain handgrip at 30 percent MVC for 2 min. A recovery period of 10 minutes between each test will be observed. For the cold face test, a cold compress (1-2 degrees Celcius) will be applied to the forehead and maxillary region of the subjections face for 2 min. Following these baseline tests, participants will be asked to consume a dose of CBD (determined following analyses of the initial 4 sessions) and perform the two autonomic stress tests again 2h post ingestion.

Tracking Information

NCT #
NCT04731779
Collaborators
Not Provided
Investigators
Not Provided