Cannabidiol (CBD) for PTSD Symptoms in Adults
This study is testing if Cannabidiol (Nantheia ATL5) can help adults with Post-Traumatic Stress Disorder (PTSD) symptoms. You might be able to join if you are 21-65 years old, can read English, and have PTSD. Participants will take either Nantheia ATL5 or a placebo (an inactive pill) twice daily in gel capsules. The main goal is to see how your PTSD symptoms change over 8 weeks. The study is currently unclear on its recruitment status and plans to enroll 180 people.
- Study design
- This is a double-blind study, meaning neither you nor the study team will know if you are receiving Nantheia ATL5 or a placebo. It aims to enroll 180 participants.
- What's involved
- You would take 4 gel capsules twice daily for 8 weeks and have your PTSD symptoms measured at the beginning and end of this period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your PTSD symptoms will be measured at baseline and after 8 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05269459
Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults
Recruiting
PHASE2Ages 21–65InterventionalTreatmentUniversity of NebraskaInvestigator-initiated
~180 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Cannabidiol Administered as Nantheia ATL5Placebo
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Post-traumatic Stress Disorder Symptom Rating
Measured over Baseline and 8 weeks
Conditions
Where it's being run
1 sites across 1 statesNebraska1
Study leadership
- Matthew Rizzo, MD · PRINCIPAL_INVESTIGATOR · University of Nebraska
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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)
History of diagnosed PTSD
Pregnant (self-reported) or breastfeeding
Claustrophobia, pregnancy, or any condition (e.g., significant hearing difficulties) that would preclude MRI scanning, in the clinical judgment of the investigator
Presence of metal objects in or on the body (e.g., pacemakers, aneurysm clips, metallic prostheses, bone plates, braces, orthodontic devices, cochlear implants/hearing aids, non-removable piercings/implants or metallic-ink tattoos, or shrapnel fragments)
Other confounding medical conditions (e.g., Tourette's or Tic Disorder) that would preclude MRI scanning, in the clinical judgement of the investigator
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
What this trial measures
- Post-traumatic Stress Disorder Symptom RatingBaseline and 8 weeks
Structured clinician-administered rating of post-traumatic stress disorder (PTSD) symptoms' severity using the Diagnostic and Statistical Manual of Mental Disorders (DSM-5; CAPS-5) Scale. This instrument assesses 20 PTSD symptoms. Each symptom is scored 0 - 4, then symptom scores are totaled. Higher scores indicate greater symptom severity.