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

NCT05269459 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 0159-22-FB
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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, 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).

Conditions

PTSD

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Post-traumatic Stress Disorder Symptom Rating

  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.

  Baseline and 8 weeks

Secondary Outcomes (8)

• Post-traumatic Stress Disorder Symptom Symptom Cluster Rating

  Baseline and 8 weeks

• Post-traumatic Stress Disorder Symptom Rating (Self-reported)

  Baseline and 8 weeks

• Clinical Global Impression Post-traumatic Stress Disorder - Severity

  Baseline and 8 weeks

• Clinical Global Impression - Improvement

  Baseline and 8 weeks

• Anxiety Severity Rating

  Baseline and 8 weeks

Other Outcomes (6)

• Treatment-Emergent Adverse Events

  8 weeks

• Hepatic Function Measured by Serum Alanine Aminotransferase

  Baseline and 8 weeks

• Hepatic Function Measured by Serum Aspartate Aminotransferase

  Baseline and 8 weeks

Study Arms (3)

Cannabidiol Administered as Nantheia ATL5 Group

EXPERIMENTAL

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.

Drug: Cannabidiol Administered as Nantheia ATL5

Placebo Group

PLACEBO COMPARATOR

Matching placebo capsules will be administered twice a day to Placebo Group.

Drug: Placebo

Control Group

NO INTERVENTION

Baseline data collection only will be collected from Control group.

Interventions

Cannabidiol Administered as Nantheia ATL5 DRUG

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

Also known as: CBD

Cannabidiol Administered as Nantheia ATL5 Group

Placebo DRUG

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

Also known as: PBO

Placebo Group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• PTSD Participants
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• Ananda Scientific Inc: collaborator
• University of Texas at Austin: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Related Publications (13)

• Association, A. P. (2013). Diagnostic and Statistical Manual 5. Washington D.C.: American Psychiatric Association.

  BACKGROUND

• Association, A. P. (2017). Medications for PTSD. Retrieved from https://www.apa.org/ptsd-guideline/treatments/medications

  BACKGROUND

• Stanciu CN, Brunette MF, Teja N, Budney AJ. Evidence for Use of Cannabinoids in Mood Disorders, Anxiety Disorders, and PTSD: A Systematic Review. Psychiatr Serv. 2021 Apr 1;72(4):429-436. doi: 10.1176/appi.ps.202000189. Epub 2021 Feb 3.

  PMID: 33530732 BACKGROUND

• Wall MB, Pope R, Freeman TP, Kowalczyk OS, Demetriou L, Mokrysz C, Hindocha C, Lawn W, Bloomfield MA, Freeman AM, Feilding A, Nutt D, Curran HV. Dissociable effects of cannabis with and without cannabidiol on the human brain's resting-state functional connectivity. J Psychopharmacol. 2019 Jul;33(7):822-830. doi: 10.1177/0269881119841568. Epub 2019 Apr 23.

  PMID: 31013455 BACKGROUND

• Sholler DJ, Schoene L, Spindle TR. Therapeutic Efficacy of Cannabidiol (CBD): A Review of the Evidence from Clinical Trials and Human Laboratory Studies. Curr Addict Rep. 2020 Sep;7(3):405-412. doi: 10.1007/s40429-020-00326-8. Epub 2020 Jul 25.

  PMID: 33585159 BACKGROUND

• Marx BP, Lee DJ, Norman SB, Bovin MJ, Sloan DM, Weathers FW, Keane TM, Schnurr PP. Reliable and clinically significant change in the clinician-administered PTSD Scale for DSM-5 and PTSD Checklist for DSM-5 among male veterans. Psychol Assess. 2022 Feb;34(2):197-203. doi: 10.1037/pas0001098. Epub 2021 Dec 23.

  PMID: 34941354 BACKGROUND

• Hurd YL. Leading the Next CBD Wave-Safety and Efficacy. JAMA Psychiatry. 2020 Apr 1;77(4):341-342. doi: 10.1001/jamapsychiatry.2019.4157. No abstract available.

  PMID: 31940016 BACKGROUND

• Elsaid S, Kloiber S, Le Foll B. Effects of cannabidiol (CBD) in neuropsychiatric disorders: A review of pre-clinical and clinical findings. Prog Mol Biol Transl Sci. 2019;167:25-75. doi: 10.1016/bs.pmbts.2019.06.005. Epub 2019 Aug 28.

  PMID: 31601406 BACKGROUND

• Andrewes DG, Jenkins LM. The Role of the Amygdala and the Ventromedial Prefrontal Cortex in Emotional Regulation: Implications for Post-traumatic Stress Disorder. Neuropsychol Rev. 2019 Jun;29(2):220-243. doi: 10.1007/s11065-019-09398-4. Epub 2019 Mar 14.

  PMID: 30877420 BACKGROUND

• Babson KA, Sottile J, Morabito D. Cannabis, Cannabinoids, and Sleep: a Review of the Literature. Curr Psychiatry Rep. 2017 Apr;19(4):23. doi: 10.1007/s11920-017-0775-9.

  PMID: 28349316 BACKGROUND

• Elms L, Shannon S, Hughes S, Lewis N. Cannabidiol in the Treatment of Post-Traumatic Stress Disorder: A Case Series. J Altern Complement Med. 2019 Apr;25(4):392-397. doi: 10.1089/acm.2018.0437. Epub 2018 Dec 13.

  PMID: 30543451 BACKGROUND

• Hori H, Kim Y. Inflammation and post-traumatic stress disorder. Psychiatry Clin Neurosci. 2019 Apr;73(4):143-153. doi: 10.1111/pcn.12820. Epub 2019 Feb 21.

  PMID: 30653780 BACKGROUND

• Jackson BN, Weathers FW, Jeffirs SM, Preston TJ, Brydon CM. The revised Clinician-Administered PTSD scale for DSM-5 (CAPS-5-R): Initial psychometric evaluation in a trauma-exposed community sample. J Trauma Stress. 2025 Feb;38(1):40-52. doi: 10.1002/jts.23093. Epub 2024 Aug 23.

  PMID: 39176447 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Matthew Rizzo, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brigette S Vaughan, MSN

CONTACT

402-552-6239; bvaughan@unmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and study personnel are blinded to treatment assignment. Randomization will occur in blocks based on self-reported marijuana use (yes/no). Randomization schedule will be provided by the statistician to the research pharmacist for study drug dispensing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-Blind Placebo Controlled Study

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 8, 2022
• Study Start: December 1, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)