Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Life's End Benefits of cannaBidiol and tetrahYdrocannabinol
NCT05644262 · View on ClinicalTrials.gov ↗
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG T2:C100
Study Locations (10)
District of Columbia
- Georgetown University — Washington D.C.
- Howard University — Washington D.C.
Florida
- Melgar-Caro Medcenter and Community Research (MCMCR) — Miami
- University of South Florida — Tampa
Kentucky
- University of Kentucky — Lexington
Louisiana
- Pennington Biomedical Research Center — Baton Rouge
Maryland
- University of Maryland — Baltimore
Ohio
- Case Western Reserve University — Beachwood
South Carolina
- Ralph H. Johnson VA Medical Center — Charleston
Tennessee
- Vanderbilt University Medical Center Center for Cognitive Medicine — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-12-18 |
| Est. Completion | 2026-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05644262
The ClinicalTrials.gov registry entry for NCT05644262 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 412 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Dementia appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05644262 reports 10 study locations spanning 8 distinct geographic areas — top geographies include District of Columbia, Florida, Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05644262 about?
NCT05644262 is a clinical study titled "Life's End Benefits of cannaBidiol and tetrahYdrocannabinol". 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 ag...
What is the current status of trial NCT05644262?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2023-12-18. Estimated completion is 2026-03.
What conditions does trial NCT05644262 study?
This clinical trial studies the following conditions: Dementia, Agitation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05644262?
The interventions under investigation include: Placebo (DRUG), T2:C100 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05644262?
This trial is sponsored by University of Southern California, which has 412 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05644262 being conducted?
This trial has 10 study locations across District of Columbia, Florida, Kentucky, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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