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Cannabidiol Medication Intervention Trial

Study acronym: CALM-IT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv9
  2. Site details revised at 5 of 5 sitesv8
  3. Site details revised at 1 of 5 sitesv7
  4. Study sites: 3 to 5
    • Eligibility criteria shortened, about 67 words
    v6
  5. Collaborators expanded, about 3 wordsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Enrollment target: 60 to 40v4 Show 5 more changesShow less
    • Interventions: JZP541 (Drug), Placebo (Other) to CBD (Drug), Placebo (Other)
    • Eligibility criteria shortened, about 53 words
    • Secondary endpoints revised (6)
    • Study description shortened, about 4 words
    • Study title shortened, about 1 word
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 20, 2023 to Sep 27, 2023
    • Site details revised at 3 of 3 sites
    v3
  3. Start date: Aug 20, 2023 to Sep 20, 2023
    • Interventions: JZP541 (Drug) to JZP541 (Drug), Placebo (Other)
    • Secondary endpoints: details revised at 1 of 6 entries
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
CALM-IT is a Randomized, double-blind, placebo-controlled cross-over clinical trial. Safety and efficacy of cannabidiol (CBD) capsules assessed for managing agitation in patients with AD and to identify novel biomarkers of agitation severity and treatment response.
Trial Details
NCT Number NCT06014424
Lead Sponsor Sunnybrook Health Sciences Centre
Collaborators: Weston Brain Institute
Conditions
(from sponsor)		 Alzheimer Disease
Related terms Alzheimer Disease
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov