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NCT02102113

Probing the Cannabinoid System in Individuals With a Family History of Psychosis

StatusActive, Not Recruiting
PhaseEarly Phase 1
Primary completion (estimated)

At risk: Primary completion moved at least 1 year 11 months later.

See at-risk trials from Yale University

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Record History

All 22 versions: 14 with changes below, 8 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 2026 to Jun 2028 Show 5 more changesShow less
    • Eligibility criteria expanded, about 22 words
    • Final enrollment: 27 participants (planned 21)
    • Study completion pushed from Dec 2026 to Dec 2028
    • Secondary endpoints: details revised at 4 of 4 entries
    • Collaborators expanded, about 4 words
  2. Primary completion date: Jun 2025 to Jun 2026
    • Study completion date: Dec 2025 to Dec 2026
    v21
  3. Primary completion date: Jun 2024 to Jun 2025
    • Study completion date: Dec 2024 to Dec 2025
    v20
  4. Primary completion date: Jun 2023 to Jun 2024
    • Study completion date: Dec 2023 to Dec 2024
    v18
  5. Primary completion date: Jun 2022 to Jun 2023
    • Study completion date: Dec 2022 to Dec 2023
    v17
Show 8 earlier versionsHide 8 earlier versions
  1. Phase: Not applicable to Early Phase 1
    • Primary completion date: Jun 2021 to Jun 2022
    • Study completion date: Dec 2021 to Dec 2022
    v16
  2. Study completion date: Jun 2021 to Dec 2021v15
  3. Primary and study completion dates: Jun 2020 to Jun 2021v14
  4. Primary and study completion dates: Jan 2020 to Jun 2020v13
  5. Enrollment target: 72 to 21
    • Primary and study completion dates: Apr 2019 to Jan 2020
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v12
  6. Primary and study completion dates: Apr 2018 to Apr 2019v11
  7. Primary and study completion dates: Apr 2017 to Apr 2018v10
  8. Site contact updatedv7
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Positive and Negative Symptom Scale for Schizophrenia (PANSS)
Timeframe: -30 min from administration of THC

Secondary (4)

Clinician Administered Dissociative Symptoms Scale (CADSS)
Visual Analog Scale (VAS)
Hopkins Verbal Learning Test (HVLT)
Psychotomimetic States Inventory (PSI)

Arms and interventions

No Family History of Psychosis (FHN)Other

Individuals recruited with no history of psychosis in the family. They will receive the placebo, very low dose THC, and low dose THC interventions.

Family History of Psychosis (FHP)Experimental

Individuals with a family member with a confirmed diagnosis of psychosis. They will receive the placebo, very low dose THC, and low dose THC interventions.

Drugs: Placebo, Very Low Dose THC, Low Dose THC

Sites

1 site in 1 country

  • VA Connecticut Healthcare SystemWest Haven, Connecticut, United States