Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions

PHASE1CompletedINTERVENTIONAL
Enrollment

241

Participants

Timeline

Start Date

February 8, 2024

Primary Completion Date

September 6, 2024

Study Completion Date

September 6, 2024

Conditions
CannabidiolDrug Induced Liver InjuryDrug Interaction
Interventions
DRUG

Cannabidiol

Cannabidiol (Epidiolex) will be administered orally 2.5 mg/kg twice daily (5 mg/kg/day) for 28 days in Part 1 and for 9 days (morphine cohort) or 12 days (citalopram cohort) in Part 2.

DRUG

Placebo

Placebo will be administered orally twice daily for 28 days in Part 1

DRUG

Citalopram

Citalopram (Celexa) will be administered once at 20 mg on days 1 and 13.

DRUG

Morphine

Morphine will be administered once at 15 mg on days 1, 4, and 11.

Trial Locations (1)

53095

Spaulding Clinical Research, West Bend

All Listed Sponsors
collaborator

Spaulding Clinical Research LLC

OTHER

lead

Food and Drug Administration (FDA)

FED

NCT06192589 - Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions | Biotech Hunter | Biotech Hunter