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NCT05132699 | Completed | Posttraumatic Stress Disorder

Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder
Sponsor:

The University of Texas Health Science Center at San Antonio

Information provided by (Responsible Party):

Casey Straud

Brief Summary:

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.

Condition or disease

Posttraumatic Stress Disorder

Stress Disorders, Post-Traumatic

Intervention/treatment

Cannabidiol (CBD) oral solution

Placebo

Massed Prolonged Exposure (mPE)

Phase

Phase 1

Phase 2

Detailed 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 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=12) vs. placebo (n=12) 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.}}

Study Type : Interventional
Estimated Enrollment : 22 participants
Masking : Double
Masking Description : A compounding pharmacy will supply both the study drug and a matching strawberry flavored liquid.
Primary Purpose : Treatment
Official Title : Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder: A Pilot Study
Actual Study Start Date : April 4, 2022
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023
Arm Intervention/treatment

Active Comparator: Cannabidiol (CBD)

Epidiolex oral solution 500mg (5ml) per day

Drug: Cannabidiol (CBD) oral solution

Behavioral: Massed Prolonged Exposure (mPE)

Placebo Comparator: Placebo

Placebo oral solution 5ml per day

Drug: Placebo

Behavioral: Massed Prolonged Exposure (mPE)
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Individuals between the age of 18 to 65 years old at time of screening.
  • Able to write, read, and speak English
  • PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
  • Stable medication regimen for at least four weeks prior to the onset of study participation.
Exclusion Criteria
  • History of opiate, cocaine, methamphetamine, benzodiazepine, or cannabis abuse as determined by the National Institute of Drug Abuse Quick Screen (NIDA-Q).
  • Currently using opiates, cocaine, methamphetamines, benzodiazepines, or cannabis as evidenced by a positive urine drug screen prior to enrollment.
  • Currently pregnant as determined by a positive urine pregnancy test prior to enrollment.
  • Current clinically significant alcohol abuse in the past two weeks on the Quick Drinking Screen (QDS).
  • Currently breastfeeding.
  • Ongoing illness or physical health problem(s) that may be exacerbated by CBD (e.g., history of liver problems)
  • History of significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to cannabinoids.
  • Concomitant medications with possible CBD-drug interactions
  • Alanine transaminase (ALT) or Aspartate transaminase (AST) enzyme levels 3x normal limits.
  • Concurrent engagement in trauma-related psychotherapy for PTSD.
  • Current or past DSM-5 diagnosis of psychotic disorder or bipolar disorder as determined on the Mini International Neuropsychiatric Interview (MINI 7.0).
  • 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).
  • Allergy to sesame seed oil.
Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder

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Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder

How to Participate

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Locations

Not yet recruiting

United States, Texas

University of Texas Health Science Center at San Antonio - STRONG STAR Northwest Center

Saint Anthony, Texas, United States, 78229