The Pharmacokinetics and Pharmacodynamics of Oral and Vaporized Cannabidiol

• Status: Completed
• Trial end date: 2020-01-22
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the pharmacokinetics and pharmacodynamics of cannabidiol administered via inhalation and oral ingestion.

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

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Cannabidiol

Criteria

Inclusion Criteria

1. Have provided written informed consent

2. Be between the ages of 18 and 45

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 (confirmed by GC/MS laboratory test) 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. Demonstrate ability to expectorate 3-5 mL of "native" oral fluid over a 5-minute period

7. 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.

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

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

10. 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

11. Have no allergies to any of the ingredients used to prepare cannabis brownies (chocolate, eggs, wheat, etc.).

12. Report prior experience inhaling cannabis (either via smoking or vaporization).

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 OTC, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days of experimental sessions; 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 experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.

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).