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Clinical trialNCT05644262Active, not recruitingPhase 2Interventional

Life's End Benefits of cannaBidiol and tetrahYdrocannabinol

SponsorUniversity of Southern CaliforniaEnrollment120AgitationDementia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. This study will enroll approximately 120 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks. A 12 week optional open-label extension will be offered to participants who complete the double-blind period.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Georgetown University

    Washington D.C., District of Columbia, United States

  • Howard University

    Washington D.C., District of Columbia, United States

  • Melgar-Caro Medcenter and Community Research (mcmcr)

    Miami, Florida, United States

  • University of South Florida

    Tampa, Florida, United States

  • University of Kentucky

    Lexington, Kentucky, United States

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, United States

  • University of Maryland

    Baltimore, Maryland, United States

  • Case Western Reserve University

    Beachwood, Ohio, United States

  • Ralph H. Johnson Va Medical Center

    Charleston, South Carolina, United States

  • Vanderbilt University Medical Center Center for Cognitive Medicine

    Nashville, Tennessee, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PlaceboT2:C100
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
18 Dec 2023
Primary completion
30 Apr 2026
Completion
1 Aug 2026
Last update posted
4 May 2026
Registered enrollment
120
Registry id
NCT05644262

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.