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

Primary Purpose

PTSD

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol (CBD) as Nantheia ATL5
Placebo
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, CBD, Nantheia ATL5, Quality of Life, Mobility, Tolerability, Cannabidiol

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 uses 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. Suicide attempt in the 6 months prior to enrollment or answer of "yes" to item 4 or 5 on the baseline Columbia Suicide Severity Rating Scale (C-SSRS).
  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).

Sites / Locations

  • University of Nebraska Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Cannabidiol (CBD) as Nantheia ATL5

Placebo

Control Population

Arm Description

Cannabidiol (CBD) as Liquid Structure Formulation Nantheia ATL5 400mg BID. Administered in 100mg softgel capsules. Each 100mg softgel contains 10% CBD.

Matching placebo

Control group for purposes of baseline data collection

Outcomes

Primary Outcome Measures

CAPS-5
Clinician administered rating of PTSD symptoms

Secondary Outcome Measures

SF-36
Self-reported measure of quality of life

Full Information

First Posted
February 24, 2022
Last Updated
September 28, 2023
Sponsor
University of Nebraska
Collaborators
Ananda Scientific Inc, University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT05269459
Brief Title
Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults
Official Title
Safety and Efficacy of Cannabidiol (CBD) for Symptoms of Post-Traumatic Stress Disorder (PTSD) in Adults Using Liquid StructureTM Formulation (NantheiaTM ATL5).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
May 2027 (Anticipated)
Study Completion Date
August 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
Ananda Scientific Inc, University of Texas at Austin

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 comparison subjects are enrolled and complete baseline data collection only. All subjects may complete optional procedures of driving assessments and functional MRI (fMRI).
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 (IL6, TNF, 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 control subjects who agree to complete the fMRI procedures, the driving measures, and providing an additional sample of blood to store for future unspecified research. PTSD subjects' baseline characteristics will be evaluated overall and relative to subjects without PTSD (controls) during a 3-week baseline period prior to randomization (Nantheia ATL5 or placebo [PBO]). Comparisonl subjects will complete the study at end of baseline and PTSD subjects will be randomized 1:1 to Nantheia ATL5 or placebo (PBO). Comparison subjects who consent to fMRI will return for a second scan 2 weeks after the end of baseline. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD, CBD, Nantheia ATL5, Quality of Life, Mobility, Tolerability, Cannabidiol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-Blind Placebo Controlled Study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Subjects 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.
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cannabidiol (CBD) as Nantheia ATL5
Arm Type
Experimental
Arm Description
Cannabidiol (CBD) as Liquid Structure Formulation Nantheia ATL5 400mg BID. Administered in 100mg softgel capsules. Each 100mg softgel contains 10% CBD.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Arm Title
Control Population
Arm Type
No Intervention
Arm Description
Control group for purposes of baseline data collection
Intervention Type
Drug
Intervention Name(s)
Cannabidiol (CBD) as Nantheia ATL5
Other Intervention Name(s)
CBD
Intervention Description
Gel caps containing 100mg of Nantheia ATL5. Subjects will take 4 capsules twice daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
PBO
Intervention Description
Matching gel caps containing no active drug. Subjects will take 4 capsules twice daily.
Primary Outcome Measure Information:
Title
CAPS-5
Description
Clinician administered rating of PTSD symptoms
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
SF-36
Description
Self-reported measure of quality of life
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All Subjects: Ability and willingness to provide informed consent Stated willingness to comply with all study procedures and availability for the duration of the study Male or female, aged 21-65 Able to read and communicate in English. THC use must be less than 3 uses per week Subjects who consent to driving procedures: 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). 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 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. Clinician administered CAPS-5 score ≥27 at study induction and start of CBD observation. Stable psychopharmacologic and/or psychotherapeutic intervention for 4 weeks prior to enrollment. Exclusion Criteria: All Subjects: Current use of prescribed or commercially available CBD products, including Epidiolex®. Suicide attempt in the 6 months prior to enrollment or answer of "yes" to item 4 or 5 on the baseline Columbia Suicide Severity Rating Scale (C-SSRS). 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 in the 6 months prior to study entry based on the MINI. Nicotine dependence is 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, measured by serum 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 (see Appendix A). Treatment with another investigational drug or other intervention within the 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 in the 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 HIV medications (PrEP is permitted). Control Subjects: No history of diagnosed PTSD. Pregnant, measured by self-report, or breastfeeding Subjects who consent to fMRI procedures: 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 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. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brigette S Vaughan, MSN
Phone
402-552-6239
Email
bvaughan@unmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Rizzo, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brigette Vaughan, MSN
Phone
402-552-6239
Email
bvaughan@unmc.edu
First Name & Middle Initial & Last Name & Degree
Matthew Rizzo, MD

12. IPD Sharing Statement

Citations:
Citation
Association, A. P. (2013). Diagnostic and Statistical Manual 5. Washington D.C.: American Psychiatric Association.
Results Reference
background
Citation
Association, A. P. (2017). Medications for PTSD. Retrieved from https://www.apa.org/ptsd-guideline/treatments/medications
Results Reference
background
PubMed Identifier
33530732
Citation
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.
Results Reference
background
PubMed Identifier
31013455
Citation
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.
Results Reference
background
PubMed Identifier
33585159
Citation
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.
Results Reference
background
PubMed Identifier
34941354
Citation
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.
Results Reference
background
PubMed Identifier
31940016
Citation
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.
Results Reference
background
PubMed Identifier
31601406
Citation
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.
Results Reference
background
Citation
FDA. (2017). Evaluating Drug Effects on the Ability to Operate a Motor Vehicle.
Results Reference
background
PubMed Identifier
30877420
Citation
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.
Results Reference
background
PubMed Identifier
28349316
Citation
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.
Results Reference
background
PubMed Identifier
30543451
Citation
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.
Results Reference
background
PubMed Identifier
30653780
Citation
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.
Results Reference
background
PubMed Identifier
34306907
Citation
Merickel J, High R, Smith L, Wichman C, Frankel E, Smits K, Drincic A, Desouza C, Gunaratne P, Ebe K, Rizzo M. Driving Safety and Real-Time Glucose Monitoring in Insulin-Dependent Diabetes. Int J Automot Eng. 2019;10(1):34-40. doi: 10.20485/jsaeijae.10.1_34. Epub 2019 Feb 4.
Results Reference
background
Citation
Merickel, J., Robin, H., Smith, L., Wichman, C., Frankel, E., Smits, K., . . . Rizzo, M. (2017). At-risk driving behavior in drivers with diabetes: A neuroergonomics approach. Proceedings of the Human Factors and Ergonomics Society Annual Meeting, 61(1), 1881-1885.
Results Reference
background

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

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