Recruiting
Phase 2

Nantheia ATL5

Sponsor:

University of Nebraska

Code:

NCT05269459

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Cannabidiol Administered as Nantheia ATL5

Placebo

Study Details

Brief summary:

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.

Conditions

PTSD

Study ID

NCT05269459

Start date

Dec 1, 2022

Status verified date

Jul, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Ability and willingness to provide informed consent
  • Stated willingness to comply with all study procedures and availability for duration of the study
  • Aged 21-65 years
  • Able to read and communicate in English
  • Tetrahydrocannabinol (THC) use less than 3 days per week
  • Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for a current diagnosis of Post-Traumatic Stress Disorder (PTSD) on the Mini-Mental State examination (MMS), with symptoms present for at least 1 month
  • Clinician administered Clinical Assessment of Pragmatics (CAPs) score ≥27 at study enrollment and start of Cannabidiol (CBD) observation
  • Stable psychopharmacologic and/or psychotherapeutic intervention for 4 weeks prior to enrollment

Exclusion Criteria

  • Current use of prescribed or commercially available CBD products, including Epidiolex®
  • Suicidal ideation (as defined by answer of "yes" to item 4 or 5 on the baseline Columbia Suicide Severity Rating Scale (C-SSRS) or attempt within 6 months prior to enrollment)
  • Cognitive impairment in the clinical judgment of the investigator that would impact ability to complete study assessments or confound study results (e.g., neurodegenerative condition or other)
  • Meets criteria for substance or alcohol use disorder of moderate or greater severity within 6 months prior to study enrollment based on the Mini-Mental State examination (MMS); nicotine dependence permitted
  • Self-reported cannabis use on > 3 days/week starting 4 weeks prior to enrollment
  • Positive urine drug screen for illicit substances other than cannabis
  • Pregnant \[confirmed by serum human chorionic gonadotropin (hCG) test\], or breastfeeding
  • Co-morbid medical conditions or concomitant treatments that may adversely impact ability to participate in the trial in the clinical judgment of the investigator \[e.g., significant immunosuppression due to active chemotherapy, recent organ transplant, uncontrolled diabetes, glomerular filtration rate (GFR) < 25ml/min or on dialysis, recent acute myocardial infarction (MI), Class IV heart failure, or taking any high-risk drugs for drug-drug interactions\]
  • Treatment with another investigational drug or other intervention within 3 months prior to enrollment
  • History of psychosis (schizophrenia, schizophreniform disorder, schizoaffective disorder, or substance induced psychosis), active bipolar disorder, or borderline personality disorder diagnosed by a mental health professional
  • History of open head injury
  • Self-report of exposure to trauma within 30 days prior to enrollment
  • Active military service in the 30 days prior to enrollment
  • Inpatient psychiatric hospitalization within 6 months prior to enrollment
  • Seizure in the last 6 months
  • Use of concomitant anti-viral human immunodeficiency virus (HIV) medications (PrEP permitted)
  • Index trauma before age 18 and no other traumatic experiences which could relate/identify as part of PTSD
  • History of allergic reaction or significant adverse events (AE) related to cannabis, CBD, or THC
  • Currently involved in events giving rise to PTSD
  • Alanine transaminase (ALT)/Aspartate transaminase (AST)/Bilirubin > 2 x upper limit of normal (ULN) at screening (abnormalities on the comprehensive metabolic panel or complete blood count deemed to be of clinical significance in the judgement of the investigator and clinical team will be evaluated in the clinical context of the participant's history and physical examination to determine eligibility and testing may be repeated if clinically appropriate at the discretion of the investigator)
  • Refusal to use at least one form of birth control throughout study participation \[including, but are not limited to, male or female condoms, diaphragm, or cervical cap (all with or without spermicide) abstinence, or hormonal/implanted birth control, e.g., pill, injection, intra-uterine device (IUD), implant\] by participants who can become pregnant

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Cannabidiol Administered as Nantheia ATL5

Participants will take 4 gel capsules twice daily containing 100mg of Nantheia ATL5.

Placebo

Participants will take 4 matching gel capsules twice daily containing no active drug.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Brigette S Vaughan, MSN

402-552-6239bvaughan@unmc.edu

Locations

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Brigette Vaughan, MSN

402-552-6239bvaughan@unmc.edu

Principal Investigator:

Matthew Rizzo, MD

More Information

Sponsor

University of Nebraska

Last update posted

Sep 17, 2026

Last verified

Jul, 2026

Keywords

  • PTSD
  • CBD
  • Nantheia ATL5
  • Quality of Life
  • Mobility
  • Tolerability
  • Cannabidiol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-09-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.