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Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 22% 180 → 140 participants
See other at-risk trials from University of Nebraska

Record History

  1. Enrollment reduced: 180 → 140 participants Trial arms changed: 3 → 2 · Eligibility criteria shortened, about 72 words · Secondary endpoints: details revised at 8 of 8 entries · 2 more Show 5 more changesShow less
    • Trial arms changed: 3 → 2
    • Eligibility criteria shortened, about 72 words
    • Secondary endpoints: details revised at 8 of 8 entries
    • Study description shortened, about 36 words
    • Publications: details revised at 12 of 13 entries
  2. Re-verified, no change to tracked fieldsv10
  3. Primary endpoint revised Interventions: Cannabidiol (CBD) as Nantheia ATL5 (Drug), Placebo (Drug) to Cannabidiol Administered as Nantheia ATL5 (Drug), Placebo (Drug) · Eligibility criteria shortened, about 72 words · Secondary endpoints: 1 to 8 · 2 morev9 Show 5 more changesShow less
    • Interventions: Cannabidiol (CBD) as Nantheia ATL5 (Drug), Placebo (Drug) to Cannabidiol Administered as Nantheia ATL5 (Drug), Placebo (Drug)
    • Eligibility criteria shortened, about 72 words
    • Secondary endpoints: 1 to 8
    • Study description expanded, about 123 words
    • Publications: 15 to 13

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: May 2027 to Dec 2028 Completion date: Aug 2027 to Apr 2029v8 Show 1 more changeShow less
    • Completion date: Aug 2027 to Apr 2029
  5. Re-verified, no change to tracked fieldsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Study description shortened, about 15 words Eligibility criteria expanded, about 4 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study site revisedv5 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv4
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Nov 2022 to Dec 1, 2022v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2022 to Dec 1, 2022
  5. Start date: May 2022 to Nov 2022 Eligibility criteria expanded, about 91 words · Study description shortened, about 41 wordsv2 Show 2 more changesShow less
    • Eligibility criteria expanded, about 91 words
    • Study description shortened, about 41 words

    See this version in full on ClinicalTrials.gov ↗

  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.
University of Nebraska
110 trials monitored
See 13 trials at risk
PTSD
821 trials monitored
See 49 trials at risk
Post-traumatic stress disorder (PTSD) is a psychiatric disorder than may develop following a traumatic event including serious incidents, natural or human-caused disasters, violence, death of a loved one, receipt of traumatic news, or serious illness/hospitalization. While half of US adults experience trauma in their lifetime, most do not develop PTSD. However, those who do develop the disorder may have significant impairments and risk for functional dysfunction across multiple domains. While short term symptoms are the most common, some individuals develop chronic PTSD. These individuals may experience frightening and intrusive thoughts and memories of the event (flashbacks), have sleep disturbances, feel numb or detached, and be easily startled (hypervigilance). This trial is a double-blind placebo controlled study of cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure Formulation (Nantheia ATL5). Participants complete three weeks of baseline data collection including assessments of activity and sleep. Intervention is Nantheia ATL5 or placebo. Dose is initiated at 400mg BID and maintained over 8 weeks. Standardized symptom profile measurements, clinician assessments, laboratory testing, and suicide screening is completed throughout.
Trial Details
NCT Number NCT05269459
Lead Sponsor University of Nebraska
Collaborators: Ananda Scientific, University of Texas at Austin
Conditions PTSD
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov