Use of Cannabidiol (CBD) Oil in the Treatment of PTSD: A Placebo-Controlled Randomized Clinical Trial

2019-05-0123

The overarching objective of the proposed project is to test the clinical efficacy of CBD in the treatment of post-traumatic stress disorder using a rigorous double-blind randomized clinical trial methodology. Participants (n=150) meeting full DSM-5 criteria for post-traumatic stress disorder (PTSD) will be randomized to one of 3 treatment arms: (a) CBD -Isolate; (b) CBD-Broad Spectrum; (c) Placebo oil. We predict that patients receiving CBD isolate or CBD Broad Spectrum will show significantly greater improvements in PTSD symptoms and functional impairment at the posttreatment and one-month follow-up relative to patients receiving placebo oil. Additionally, we expect that patients receiving CBD Broad Spectrum will show significantly greater improvements relative to patients receiving CBD Isolate.

2020-01-15

2024-05-01

2025-05-01

Early phase I

150

Inclusion Criteria: 1. Meets for a current DSM-5 diagnosis of PTSD as their "primary" mental disorder 2. Age 18 or older 3. Fluent in English 4. Has access to the internet 5. Willingness to provide signed informed consent 6. Willingness to refrain from all non-study cannabis use during the study period Exclusion Criteria: 1. History of a suicide attempt within the past 6 months 2. History of psychosis within the past 6 months 3. History of current alcohol or substance use disorder within the past month 4. Any medical problems that would preclude participating in the study 5. History of adverse reaction to CBD oil or other CBD products 6. Allergy to coconut oil

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': "Each nightly dose of CBD/Placebo oil will be tagged with a code # on the plastic syringe containing the CBD oil or placebo oil. All oils will have identical color and mint flavor. Two independent staff not connected to the study will be unblinded to the participants' assignment to condition.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2023-11-22