The Pharmacokinetic and Pharmacodynamic Effects of Oral Cannabidiol (CBD) Under Acute and Chronic Exposure Conditions

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Epidiolex

Criteria

Inclusion Criteria:

1. Have provided written informed consent

2. Be between the ages of 18 and 55

3. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests

4. Test negative for recent cannabis use in urine at the screening visit and again upon admission for each experimental session

5. Test negative for other drugs of abuse, including alcohol at the screening visit and upon arrival for each experimental session

6. Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission.

7. Have a body mass index (BMI) in the range of 19 to 36 kg/m2

8. Have head hair that is at least 4 cm (approximately one and a half inches) in length on the back of the head.

9. Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg

10. Report prior experience using cannabis or CBD.

11. Have not donated blood in the prior 30 days.

12. Have a smartphone capable of downloading/operating the Redcap mobile application.

Exclusion Criteria:

1. Non-medical use of psychoactive drugs other than, nicotine, alcohol, or caffeine in the month prior to the screening visit.

2. History of or current evidence of significant medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures.

3. Use of an over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of study entry; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.

4. Use of a prescription medication (with the exception of birth control prescriptions) within 14 days of study entry; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject. This includes any medication metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes.

5. Use of hemp seeds or hemp oil in any form in the past 3 months.

6. Use of dronabinol (Marinol) within the past 6 months.

7. History of xerostomia (dry mouth), or the presence of mucositis, gum infection or bleeding, or other significant oral cavity disease or disorder that in the investigator's opinion may affect the collection of oral fluid samples.

8. History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina).

9. Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.

10. Epilepsy or a history of seizures.

11. Individuals who have a recent history of traumatic brain injury diagnosed by CT/MRI and have current sequela from prior brain injury, as determined by the study physician

12. Individuals with anemia