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Drug-gene-nutraceutical Interactions of Cannabidiol and Tacrolimus

StatusCompleted
PhasePhase 1
Started2022-10-31
View on ClinicalTrials.gov ↗

Amendment history

2026-10-01
Results posted: 2026-09-30
2026-06-05
Study Status, Document Section v9
Re-verified, no change to tracked fields
2026-02-11
Study Status, Oversight v8
Start date2025-08-31→2022-10-31
2025-09-26
Recruiting→Completed Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Completed
Primary completion dateestimated 2028-10→confirmed 2025-08-31
Completion dateestimated 2028-10→confirmed 2025-08-31
Start date2022-10-31→2025-08-31
Enrollment targetestimated 72→confirmed 57
Study sitesdetails revised at 1 of 1 site
2025-06-23
Study Status, Sponsor/Collaborators, Oversight, Eligibility v6
Eligibility criteria+20 characters
Inclusion Criteria: Age 18-6575 Are judged healthy enough to participate as determined by a [...] n Additional Criteria for the CKD study: Have either: A GFR betweenless 16than ml/minor andequal to 60 ml/min/1.73m2 or The presence of greater than 0.3 grams [...] o each study, or are breast feeding Are night shift workers Have an eGFR < 15 ml/min/1.73m2 or areAre on dialysis. Have compromised liver function as defined by pre-screening [...] ilirubin or AST/ALT more than 2x the upper limit of normal. HaveAre anot positivewilling urineto drugrefrain screenfrom smoking or use of marijuana for Cannabis or Marijuana at [...] [...]
Collaborators1 entry, revised
The National Center for Complementary and Integrative Health (NCCIH)
Show 5 earlier versions
2024-04-05
Study Status, Contacts/Locations v5
Re-verified, no change to tracked fields
2023-10-16
Study Identification, Study Status, Sponsor/Collaborators v4
Collaborators+60 characters
The National Center for Complementary and Integrative Health
2023-06-29
Study Status, Eligibility v3
Primary completion date2027-09→2028-10
Eligibility criteria-8 characters
[...] Have a positive urine drug screen for Cannabis or Marijuana inat the last 3 monthsscreening. Have a Hgb < 10.0 g/dL Have gastrointestinal (digestive) d [...]
2023-01-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-09→confirmed 2022-10-31
Study sites0→1
2022-08-04
Study Status, Outcome Measures v1
Secondary endpoints1 entry, revised
SecondaryImmune Outcomecell Measuresdistribution and signaling as measured by scRNA sequencing
Primary endpoints1 entry, revised
PrimaryThe OutcomeAUC0-Infinity Measuresratio of tacrolimus with cannabidiol divided by tacrolimus alone
2022-08-03
Original filing
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.
Trial Details
NCT Number NCT05490511
Lead Sponsor Indiana University
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Conditions CBD, Transplant Complication, Kidney Disease, Chronic
Enrollment 57 participants
Start Date 2022-10-31
Primary Completion 2025-08-31 (estimated)
Study Completion 2025-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-30