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

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT05269459
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Cannabidiol Administered as Nantheia ATL5 — DRUG
    Participants will take 4 gel capsules twice daily containing 100mg of Nantheia ATL5.
  • Placebo — DRUG
    Participants will take 4 matching gel capsules twice daily containing no active drug.

Study Details

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, collection of inflammatory biomarkers, and suicide screening is completed throughout. Age- and gender-matched healthy population participants are enrolled and complete baseline data collection only. All participants may complete optional functional magnetic resonance imaging (fMRI).

Key Dates

Start date
Dec 1, 2022
Status verified
May 2025
Primary completion
Dec 31, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cannabidiol Administered as Nantheia ATL5 Group
    Cannabidiol (CBD) as Liquid Structure Formulation Nantheia ATL5 400mg will be administered twice a day in 100mg softgel capsules to CBD Group. Each 100mg softgel contains 10% CBD.
  • Placebo Comparator: Placebo Group
    Matching placebo capsules will be administered twice a day to Placebo Group.
  • No Intervention: Control Group
    Baseline data collection only will be collected from Control group.

Primary Outcome Measure

Post-traumatic Stress Disorder Symptom Rating [ Time Frame: Baseline and 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198
Brigette Vaughan, MSN
[email protected]
402-552-6239
Matthew Rizzo, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Omaha, NE

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Nebraska Medical Center· Omaha, NE

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