Behavioral and Physiological Effects of THC and CBD

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate physiological and behavioral responses to vaporized delta9-Tetrahydrocannabinol (THC) and cannabidiol (CBD) administered via inhalation.

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

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Dronabinol

Criteria

Inclusion Criteria:

• Have provided written informed consent

• Be between the ages of 18 and 50

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

• Willingness to provide urine sample at the screening visit and again upon admission for the experimental session

• Test negative for recent drug or alcohol use at the screening visit and upon arrival for each experimental session.

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

• BMI 18-36

• 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

• Occasional/Intermittent cannabis users.

• Have not donated blood in the prior 30 days.

Exclusion Criteria:

• Recent non-medical use of psychoactive drugs;

• History of or current evidence of significant medical or psychiatric illness

• any condition (as determined by the study physician or investigator) that puts the participant at greater risk.

• Recent use of an over the counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the subject.

• Recent use of a prescription medication (with the exception of hormonal birth control prescriptions) 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.

• Recent use of hemp seeds or hemp oil.

• Recent use of dronabinol (Marinol).

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

• Recently enrolled in another clinical trial or have recently received any drug as part of a research study.

• Epilepsy or a history of seizures.

• 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

• Individuals with anemia

• 5th grade reading level or lower.

• Clinically relevant anxiety.

• Individuals who are night shift workers