Use of CBD Oil in the Treatment of Post-Traumatic Stress Disorder

Collaborator: Policy Lab U.S

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Summary:
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=120) meeting full DSM-5 criteria for post-traumatic stress disorder (PTSD) will be randomized to one of four treatment arms: (a) CBD oil; (b) Placebo oil; (c) CBD oil + trauma-focused group CBT, and (d) Placebo oil + trauma-focused group CBT.

We predict that patients receiving CBD monotherapy will show significantly greater improvements in PTSD symptoms and functional impairment at the posttreatment, one month, and three-month follow-up assessments relative to patients receiving placebo monotherapy. Additionally, we expect that patients receiving CBD oil plus trauma-focused psychotherapy will show significantly greater improvements relative to patients receiving combined trauma-focused psychotherapy plus placebo. We also anticipate that patients receiving trauma-focused psychotherapy will show significantly greater improvements than those receiving CBD monotherapy.

Recruitment Status: Recruiting
Study Details:
Sponsor: The University of Texas at Austin
Information provided by (Responsible Party): Michael J. Telch, the University of Texas at Austin
Condition or Disease: Post Traumatic Stress Disorder
Intervention/ Treatment: Drug: Cannabidiol (CBD) oil, Behavioral: Trauma-focused group cognitive-behavioral therapy (CBT), Placebo oil
Phase: Phase 2
Study Type: Interventional (Clinical Trial)
Estimated Enrolment: 120 participants
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Cannabidiol (CBD) Oil in the Treatment of PTSD: A Placebo-Controlled Randomized Clinical Trial
Estimated Study Start Date: December 2019
Estimated Primary Completion Date: May 2023
Estimated Study Completion Date: May 2024