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

November 14, 2023 updated by: University of Nebraska

Safety and Efficacy of Cannabidiol (CBD) for Symptoms of Post-Traumatic Stress Disorder (PTSD) in Adults Using Liquid StructureTM Formulation (NantheiaTM ATL5).

Double-blind placebo controlled study of Cannabidiol (CBD) for symptoms of PTSD in adults using liquid structure(TM) Formulation (Nantheia ATL5(TM)). Subjects complete 3 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 subjects are enrolled and complete baseline data collection only. All subjects may complete optional procedures of driving assessments and functional MRI (fMRI).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a single-site phase II, double-blind, placebo-controlled study of Nantheia ATL5 for symptoms of Post-Traumatic Stress Disorder (PTSD) in adults. Subjects will meet criteria for PTSD using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) of ≥ 27. Suicidality is assessed using the Columbia Suicide Severity Rating Scale-Revised (CSSRS-R) at all study visits. Baseline psychopharmacotherapy and/or psychotherapy must be stable (unchanged) for 4 weeks prior to enrollment, and should remain unchanged during study treatment. Effects of Nantheia ATL5 on self-reported quality of life (overall and health-related); functional status measurements of personal and driving (optional) mobility and risk, and sleep dysfunction; neurobiological biomarkers of threat response (optional functional magnetic resonance imaging: fMRI), and serum inflammatory biomarkers (CRP) implicated in PTSD pathophysiology will be assessed. Efficacy and tolerability will be assessed throughout intervention. Serum pregnancy (for subjects of child bearing potential), urine drug screening, CBC, and Comprehensive Metabolic Panel are completed at every on-site visit. Optional consent will be sought from all PTSD and healthy population subjects who agree to complete the fMRI procedures, the driving measures, and providing an additional sample of blood to store for future unspecified research. Baseline characteristics of subjects with PTSD will be evaluated overall and relative to subjects without PTSD (healthy population) during a 3-week baseline period prior to randomization (Nantheia ATL5 or placebo [PBO]). Healthy population subjects will complete the study at end of baseline and subjects with PTSD will be randomized 1:1 to Nantheia ATL5 or placebo (PBO). Study drug dose is initiated at 400mg BID and maintained for 8 weeks. Study drug is then withdrawn, and one week later safety measures including laboratory testing, assessment of AE's and CSSRS-R are repeated.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University Of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Matthew Rizzo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

All Subjects:

  1. Ability and willingness to provide informed consent
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged 21-65
  4. Able to read and communicate in English.
  5. THC use must be less than 3 days per week

Subjects who consent to driving procedures:

  1. Legally licensed and experienced drivers (>3 years driving experience), including a corrected or uncorrected visual acuity of <20/50 OU (to meet state driving requirements for vision).
  2. Active drivers (≥1hr or 25 miles driving per week). Driving a single car at least 90% of driving time (to permit installation of study driving equipment) and have car insurance for the vehicle used in the study.

PTSD Subjects

  1. Meets DSM-5 diagnostic criteria for a current diagnosis of Post-Traumatic Stress Disorder on the MINI, with symptoms present for at least 1 month.
  2. Clinician administered CAPS-5 score ≥27 at study induction and start of CBD observation.
  3. Stable psychopharmacologic and/or psychotherapeutic intervention for 4 weeks prior to enrollment.

Exclusion Criteria:

All Subjects:

  1. Current use of prescribed or commercially available CBD products, including Epidiolex®.
  2. 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 in the 6 months prior to enrollment.
  3. 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).
  4. Meets criteria for substance or alcohol use disorder of moderate or greater severity in the 6 months prior to study entry based on the MINI. Nicotine dependence is permitted.
  5. Self-reported cannabis use on > 3 days/week starting 4 weeks prior to enrollment.
  6. Positive urine drug screen for illicit substances other than cannabis.
  7. Pregnant, measured by serum hCG test, or breastfeeding.
  8. 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 (see Appendix A).
  9. Treatment with another investigational drug or other intervention within the 3 months prior to enrollment.
  10. 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.
  11. History of open head injury
  12. Self-report of exposure to trauma in the 30 days prior to enrollment.
  13. Active military service in the 30 days prior to enrollment.
  14. Inpatient psychiatric hospitalization within 6 months prior to enrollment.
  15. Seizure in the last 6 months.
  16. Use of concomitant anti-viral HIV medications (PrEP is permitted).

Control Subjects:

  1. No history of diagnosed PTSD.
  2. Pregnant, measured by self-report, or breastfeeding

Subjects who consent to fMRI procedures:

  1. Claustrophobia, pregnancy, or any condition (e.g., significant hearing difficulties) that would preclude MRI scanning in the clinical judgment of the investigator.
  2. Presence of metal objects in or on the body such as 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.

  3. Other confounding medical conditions (e.g., Tourette's or Tic Disorder) that would preclude MRI scanning in the clinical judgement of the investigator.

    PTSD Subjects:

17. Index trauma before age 18 and no other traumatic experiences which could relate/identify as part of PTSD.

18. Any history of allergic reaction or significant AEs related to cannabis, CBD, or THC.

19. Currently involved in events giving rise to the disease. 20. 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 which are deemed to be of clinical significance in the judgement of the investigator and clinical team will be evaluated in the clinical context of the subject's history and physical examination to determine eligibility. Testing may be repeated if clinically appropriate at the discretion of the investigator.

21. For subjects of who can become pregnant, refusal to use at least one form of birth control throughout study participation. Forms of birth control may include, but are not limited to, condoms (male or female) with or without spermicide, diaphragm, or cervical cap with or without spermicide, abstinence, or hormonal or implanted birth control (e.g., pill, injection, intra-uterine device [IUD], implant).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Matching gel caps containing no active drug. Subjects will take 4 capsules twice daily.
Other Names:
  • PBO
Experimental: Cannabidiol (CBD) as Nantheia ATL5
Cannabidiol (CBD) as Liquid Structure Formulation Nantheia ATL5 400mg BID. Administered in 100mg softgel capsules. Each 100mg softgel contains 10% CBD.
Drug: Cannabidiol (CBD) as Nantheia ATL5
Gel caps containing 100mg of Nantheia ATL5. Subjects will take 4 capsules twice daily.
Other Names:
  • CBD
No Intervention: Control Population
Control group for purposes of baseline data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAPS-5
Time Frame: 8 weeks
Clinician administered rating of PTSD symptoms
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36
Time Frame: 8 weeks
Self-reported measure of quality of life
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

University of Texas at Austin
Ananda Scientific Inc

Investigators

  • Principal Investigator: Matthew Rizzo, MD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

March 4, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0159-22-FB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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