Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder

The University of Texas System (UT)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Posttraumatic Stress Disorder; Stress Disorders, Post-Traumatic

Treatments: Drug: Cannabidiol (CBD) oral solution; Drug: Placebo; Behavioral: Massed Prolonged Exposure (mPE)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05132699

UL1TR002645 (U.S. NIH Grant/Contract)

HSC20210711H

KL2TR002646 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The primary goal of this pilot project is to demonstrate the safety and feasibility of using Cannabidiol (CBD) in combination with standard of care prolonged exposure (PE) psychotherapy to reduce PTSD symptoms.

Full description

This study is an early Phase II double-blind, pilot randomized controlled clinical trial. The study team will use a permuted block randomization design stratified by a Posttraumatic Stress Disorder (PTSD) severity median score on the PTSD Checklist (PCL-5) derived from a recently completed STRONG STAR repository. Participants will be up to 24 individuals with PTSD to investigate the safety, feasibility, and PTSD symptom change associated with CBD 250mg taken twice a day for 18 days (n=up to 12) vs. placebo (n=up to12) in combination with a standard of care, 10-sessions massed PE psychotherapy administered over 2 weeks. Aims 2 and 3 will evaluate biochemical and physiological outcomes associated with the brain endocannabinoid (eCB) and PTSD that may be affected by CBD. Permuted block randomization is advantageous in small clinical trials to ensure equal allocation of participants in each condition. Participant randomization will be subdivided into randomized blocks of four, two patients in each block will be assigned to CBD and two will be assigned to placebo.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Individuals between the age of 18 to 65 years old at time of screening.
2. Able to write, read, and speak English
3. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
4. Stable medication regimen for at least four weeks prior to the onset of study participation.

Exclusion criteria

1. History of opiate, cocaine, methamphetamine, benzodiazepine, or cannabis abuse as determined by the National Institute of Drug Abuse Quick Screen (NIDA-Q).
2. Currently using opiates, cocaine, methamphetamines, benzodiazepines, or cannabis as evidenced by a positive urine drug screen prior to enrollment.
3. Currently pregnant as determined by a positive urine pregnancy test prior to enrollment.
4. Current clinically significant alcohol abuse in the past two weeks on the Quick Drinking Screen (QDS).
5. Currently breastfeeding.
6. Ongoing illness or physical health problem(s) that may be exacerbated by CBD (e.g., history of liver problems)
7. History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to cannabinoids.
8. Concomitant medications with possible CBD-drug interactions
9. Alanine transaminase (ALT) or Aspartate transaminase (AST) enzyme levels 3x normal limits.
10. Concurrent engagement in trauma-related psychotherapy for PTSD.
11. Current or past DSM-5 diagnosis of psychotic disorder or bipolar disorder as determined on the Mini International Neuropsychiatric Interview (MINI 7.0).
12. Suicide attempt in the last year and/or suicide risk requiring immediate intervention or requiring a higher level of care than can be provided by the study treatment as determined by the Self-Injurious Thoughts and Behaviors Interview (SIT-BI).
13. Allergy to sesame seed oil.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

Cannabidiol (CBD)

Active Comparator group

Description:

Epidiolex oral solution 500mg (5ml) per day

Treatment:

Behavioral: Massed Prolonged Exposure (mPE)

Drug: Cannabidiol (CBD) oral solution

Placebo

Placebo Comparator group

Description:

Placebo oral solution 5ml per day

Treatment:

Behavioral: Massed Prolonged Exposure (mPE)

Drug: Placebo