Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder

NCT05132699 | Completed Phase 1 Results DMC FDA Drug

• 3 other identifiers: HSC20210711HUL1TR002645KL2TR002646
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (2)

• Clinician Administered PTSD Scale (CAPS-5)

  The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders v5 (DSM-5) criteria for PTSD. Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms.Subscale scores are calculated by summing severity scores for items in the following PTSD symptom clusters: re-experiencing, avoidance, negative alterations in cognitions and mood, and hyperarousal. Scores ≥ 25 indicate a probable diagnosis of PTSD. Scores range from 0 to 80. Change in score will be reported.

  Baseline and at about 45 days (1 month follow-up visit)

• Posttraumatic Stress Disorder Checklist (PCL-5)

  The PCL-5 is a 20-item self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. The PCL-5 evaluates how much participants have been bothered by PTSD symptoms in the past week (for all assessments during treatment) or the past two weeks (all other assessment time points) as a result of a specific life event. Each item of the PCL-5 is scored on a five-point scale ranging from 0 "not at all") to 4 ("extremely). Scores range from 0 to 80 with a higher score indicating that subjects have been bothered more by PTSD symptoms. Change in score will be reported.

  Baseline and at about 45 days (1 month follow-up visit)

Secondary Outcomes (1)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline and at about 45 Days (1 month follow-up visit)

Study Arms (2)

Cannabidiol (CBD)

ACTIVE COMPARATOR

Epidiolex oral solution 500mg (5ml) per day

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

Placebo

PLACEBO COMPARATOR

Placebo oral solution 5ml per day

Drug: Placebo; Behavioral: Massed Prolonged Exposure (mPE)

Interventions

Cannabidiol (CBD) oral solution DRUG

An oral strawberry flavored liquid, taken as a 2.5ml (250mg) dose twice a day

Also known as: Epidiolex

Cannabidiol (CBD)

Placebo DRUG

An inert strawberry flavored oral solution, taken as a 2.5ml dose twice a day

Also known as: Placebo oral solution

Placebo

Massed Prolonged Exposure (mPE) BEHAVIORAL

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.

Also known as: Behavioral Therapy

Cannabidiol (CBD); Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

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

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cannabidiol; Behavior Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Casey Straud
• Organization: University of Texas Health Science Center at San Antonio

straud@uthscsa.edu

210-562-6742

Study Officials

• Casey Straud, PsyD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A compounding pharmacy will supply both the study drug and a matching strawberry flavored liquid.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A double-blind randomized controlled clinical trial. Permuted block randomization will ensure equal allocation of participants to either study drug or placebo. Randomization will be performed by a designated study team member.

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 24, 2021
• Study Start: April 4, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study enrollment is closed and data analysis is complete. Data will be stored in the repository and accessible as long as the IRB approval for this data base remains current.

Locations

US (1)