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Drug-gene-nutraceutical Interactions of Cannabidiol and Tacrolimus

NCT05490511 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

  • CBD
  • Transplant Complication
  • Kidney Disease, Chronic

Interventions

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

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Indiana University

    lead OTHER

Principal Investigators

  • Michael Eadon, MD · Indiana University School of Medicine

  • Zeruesenay Desta, PhD · Indiana University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2025-08-31
Completion
2025-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05490511 on ClinicalTrials.gov