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

• Status: Not yet recruiting
• Trial end date: 2027-08-01
• Target enrollment: 0
• Participant gender: All

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 control subjects are enrolled and complete baseline data collection only. All subjects may complete optional procedures of driving assessments and functional MRI (fMRI).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Nebraska
• Collaborators: Ananda Scientific Inc; University of Texas at Austin
• Treatments: Cannabidiol

Criteria

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 1 use 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. Clinical Global Impression-Severity (CGI-S) ≥4 (moderate)

4. Stable psychopharmacologic and/or psychotherapeutic intervention for 4 weeks prior to enrollment.

Exclusion Criteria:

All Subjects:

1. Suicide attempt in the last year or answer of "yes" to item 4 or 5 on the C-SSRS in the month prior to entry.

2. Cognitive impairment in the opinion of the investigator or MoCA score ≤ 25 that would impact participation or ability to complete assessments/report treatment effects.

3. History of moderate or greater DSM-5 substance use disorder (≥3 symptoms), or moderate to severe alcohol use disorder (≥3 symptoms per DSM-5) within 6 months of entry. Nicotine dependence is permitted.

4. Positive urine drug screen for illicit substances other than cannabis.

5. Confounding occupation requiring nighttime shift work or variable shift work with early work start times per investigator judgement.

6. Confounding medical conditions that might impact ability to participate in the trial per investigator judgment.

7. Treatment with another investigational drug or other intervention within the last 3 months.

8. History of psychosis (schizophrenia, schizophreniform disorder, schizoaffective disorder, or substance induced psychosis) or bipolar disorder on the MINI.

9. History of open head injury.

10. Exposure to trauma in the last 30 days, including active military service.

11. Inpatient psychiatric hospitalization within the past 6 months.

12. History of Personality Disorder diagnosed by a mental health professional.

13. Use of anti-epileptic drugs taken for seizure control, including Epidiolex®.

Subjects who consent to fMRI procedures:

1. Claustrophobia, pregnancy, or any condition (for example, significant hearing difficulties) that would preclude MRI scanning per investigator judgement

2. Presence of metal objects in their bodies 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 per investigator judgement.

PTSD Subjects:

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

15. Any history of allergic reaction or significant AEs related to cannabis, CBD, or THC use per investigator assessment.

16. Currently involved in events giving rise to the disease. 17. ALT/AST/Bilirubin > 2 x upper limit of normal at entry. 18. Pregnant, measured by serum pregnancy test, or breastfeeding. 19. For subjects of reproductive potential: refusal to use 2 highly effective contraception methods for at least 1 month prior to screening and agreement to use such a method during study participation and through withdrawal period. Highly effective methods of contraception are defined as those, alone or in combination, that result in low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods include hormonal contraceptives, intrauterine devices/hormone-releasing systems, bilateral tubal occlusion, vasectomized partner or sexual abstinence and condoms.

20. Benzodiazepines use that is not stable for 4 weeks and prn use of benzodiazepines > 2 times per week

Control Subjects:

1. No history of diagnosed PTSD.

2. Pregnant, measured by self-report, or breastfeeding