NCT05132699

Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder

Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder: A Pilot Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Interventions

Type	Name	Description
DRUG	Cannabidiol (CBD) oral solution	An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day
DRUG	Placebo	An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day
BEHAVIORAL	Massed Prolonged Exposure (mPE)	mPE, delivered daily Monday through Friday over two weeks, utilizes exposure-based interventions to target psychological mechanisms (i.e., experiential and behavioral avoidance; maladaptive cognitive changes) that are thought to maintain trauma-related symptoms.

Timeline

• Start date: 2022-04-04
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2021-11-24
• Last updated: 2024-10-10
• Results posted: 2024-10-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study