Interactions Between Cannabinoids and Cytochrome P450-Metabolized Drugs

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

Summary

This study will evaluate drug-drug interactions between cannabis extracts containing Tetrahydrocannabinol (THC) and THC+ Cannabinoids (CBD) and probe drugs for select CYP450 pathways including: caffeine (CYP1A2), omeprazole (CYP2C19), losartan (CYP2C9), dextromethorphan (CYP2D6), and midazolam (CYP3A).

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

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Washington State University
• Treatments: Dronabinol

Criteria

Inclusion Criteria:

• Healthy adult between 18-50 years old

• BMI between 18 to 34 kg/m2

• Willing to use birth control

• Willing to abstain from all medications and citrus fruits for the duration of the study

Exclusion Criteria:

• Medical or psychiatric illness judged by the investigator to put the participant at greater risk of experiencing an adverse event due to drug exposure or completion of other study procedures.

• Use of medications which, in the opinion of the investigator or medical staff, will interfere with the study outcomes or the safety of the participant.

• Clinically significant impairment of kidney, liver, or thyroid function (serum creatinine >1.2 mg/ml (kidney), liver function tests >3x the upper limit of normal (alanine amino transferase >99 U/L; aspartate amino transferase > 99 U/L), and thyroid stimulating hormone > 4.2 uIU/ml), or evidence of current anemia based on blood chemistry testing.

• History of adverse events associated with the ingestion of cannabis or any medications in the Inje cocktail judged by the investigator to present an undue risk of harm to the participant.