Post Traumatic Stress Disorder Clinical Trial
Official title:
Use of Cannabidiol (CBD) Oil in the Treatment of PTSD: A Placebo-Controlled Randomized Clinical Trial
Verified date | November 2023 |
Source | University of Texas at Austin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 150 |
Est. completion date | May 2025 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Laboratory for the Study of Anxiety Disorders, University of Texas at Austin | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas at Austin |
United States,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PCL-5 | Change from baseline in patient-rated symptoms of PTSD. | Post-treatment (week 9) and one month (week 13) follow-up assessments | |
Secondary | PHQ-9 | Change from baseline in patient-rated symptoms of depression. | Post-treatment (week 9) and one month (week 13) follow-up assessments | |
Secondary | SDS | Change from baseline in overall disability. | Post-treatment (week 9) and one month (week 13) follow-up assessments | |
Secondary | WHOQOL-BREF | Change from baseline in quality of life. | Post-treatment (week 9) and one month (week 13) follow-up assessments | |
Secondary | GAD-7 | Change from baseline in patient-rated symptoms of anxiety. | Post-treatment (week 9) and one month (week 13) follow-up assessments | |
Secondary | PROMIS Alcohol Use -Short Form | Change from baseline in patient-rated alcohol use. | Post-treatment (week 9) and one month (week 13) follow-up assessments |
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