Enhancing Prolonged Exposure With Cannabidiol to Treat Posttraumatic Stress Disorder

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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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

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Posttraumatic Stress Disorder Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

A compounding pharmacy will supply both the study drug and a matching strawberry flavored liquid.

Study Groups

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Cannabidiol (CBD)

Epidiolex oral solution 500mg (5ml) per day

Group Type ACTIVE_COMPARATOR

Cannabidiol (CBD) oral solution

Intervention Type DRUG

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

Massed Prolonged Exposure (mPE)

Intervention Type 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.

Placebo

Placebo oral solution 5ml per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Massed Prolonged Exposure (mPE)

Intervention Type 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.

Interventions

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Cannabidiol (CBD) oral solution

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Epidiolex Placebo oral solution Behavioral Therapy

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes