drugset / Trial / NCT05490511
Drug-gene-nutraceutical Interactions of Cannabidiol and Tacrolimus
Phase 1
Completed
57 enrolled
Indiana University
National Center for Complementary and Integrative Health (NCCIH) · collab
Non-randomizedParallel-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2022-10-31
- Primary completion
- 2025-08-31
- Completion
- 2025-08-31
Publications
- Background Birdwell KA, Decker B, Barbarino JM, Peterson JF, Stein CM, Sadee W, Wang D, Vinks AA, He Y, Swen JJ, Leeder JS, van Schaik R, Thummel KE, Klein TE, Caudle KE, MacPhee IA. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for CYP3A5 Genotype and Tacrolimus Dosing. Clin Pharmacol Ther. 2015 Jul;98(1):19-24. doi: 10.1002/cpt.113. Epub 2015 Jun 3.
- Background Brown JD, Winterstein AG. Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. J Clin Med. 2019 Jul 8;8(7):989. doi: 10.3390/jcm8070989.
- Gisch DL, Koyama S, Etkins J, So GC, Fehrenbach DJ, Lu JBL, Cheng YH, Ferreira RM, Rajadhyaksha E, McClara K, Asghari M, Sharfuddin AA, Dagher PC, Snell LM, Madhur MS, Polidoro RB, Desta Z, Eadon MT. Cannabidiol exerts antiinflammatory effects but maintains T effector memory cell differentiation in humans. JCI Insight. 2025 Nov 18;11(1):e198590. doi: 10.1172/jci.insight.198590. eCollection 2026 Jan 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cannabidiol | Other / unclassified | 5 mg/kg | Oral |
| Comparator | Tacrolimus | Small molecule | 5 mg | — |