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

HSC20210711H

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.

2022-04-04

2023-06-30

2023-06-30

Completed

Early phase I

22

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'A compounding pharmacy will supply both the study drug and a matching strawberry flavored liquid.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}

2023-08-24