NCT05490511

Drug-gene-nutraceutical Interactions of Cannabidiol and Tacrolimus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The information learned in these studies will help to inform doctors as to how to appropriately adjust doses of cannabidiol and tacrolimus in order to improve health outcomes and long-term treatment success for transplant recipients.

Detailed description

The commercial availability of cannabidiol, or CBD oil, has increased in the United Stated and this supplement has the potential to cause a variety of drug-drug interactions, including in solid organ transplant recipients who receive tacrolimus to prevent rejection. Through a series of pharmacokinetic and pharmacodynamics assays, this proposal will identify gene-drug and drug-drug interactions (DDI), including those that place transplant recipients at risk for increased toxicity related to their immunosuppression. The information learned in these studies will help to inform practitioners as to whether cannabidiol needs to be avoided in transplant recipients and how to appropriately adjust doses of CBD and immunosuppression in order to improve health outcomes and long-term treatment success in this high-risk population.

Conditions

• CBD
• Transplant Complication
• Kidney Disease, Chronic

Interventions

Type	Name	Description
DRUG	Tacrolimus single dose	5 mg once
DRUG	Epidiolex single dose	Epidiolex 5 mg/kg
DRUG	Epidiolex steady-state and tacrolimus single dose	Epidiolex at up to 5 mg/kg twice daily (for 14 days) and tacrolimus 5 mg once on day 12 of period

Timeline

• Start date: 2022-10-31
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2022-08-05
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study