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Effects of Cannabidiol (CBD) Versus Placebo as an Adjunct to Treatment in Early Psychosis

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Jun 30, 2025 to Dec 2026 Completion date: Oct 30, 2025 to Dec 2026 · Site contacts updated at 1 of 2 sitesv5 Show 2 more changesShow less
    • Completion date: Oct 30, 2025 to Dec 2026
    • Site contacts updated at 1 of 2 sites
  2. Primary completion date: Jun 30, 2023 to Jun 30, 2025 Start date changed from estimate of Jul 1, 2021 to Jun 1, 2022 · Completion date: Jun 30, 2023 to Oct 30, 2025 · Eligibility criteria shortened, about 20 wordsv4 Show 3 more changesShow less
    • Start date changed from estimate of Jul 1, 2021 to Jun 1, 2022
    • Completion date: Jun 30, 2023 to Oct 30, 2025
    • Eligibility criteria shortened, about 20 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Start date: Mar 1, 2021 to Jul 1, 2021 · Study sites: 0 to 2v3 Show 2 more changesShow less
    • Start date: Mar 1, 2021 to Jul 1, 2021
    • Study sites: 0 to 2
  4. Start date: Jul 1, 2020 to Mar 1, 2021 Secondary endpoints: details revised at 2 of 2 entriesv2 Show 1 more changeShow less
    • Secondary endpoints: details revised at 2 of 2 entries
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an outpatient, single center, between-group, double blind, placebo controlled design. Approximately 120 adolescents and adult patients will be randomized to either have their treatment augmented with Cannabidiol Oral Solution (CBD) or with a matching CBD placebo for 8 weeks. The study will examine CBD as an augmentation strategy in early psychosis. It is hypothesized that CBD will improve symptoms, neurocognition, markers of inflammation and eating behaviors. Importantly, moderators and mediators of the CBD effects will be explored.
Trial Details
NCT Number NCT04411225
Lead Sponsor University of California, San Diego
Collaborators: Center for Medicinal Cannabis Research
Conditions Early Psychosis
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov