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Use of CBD Oil in the Treatment of Posttraumatic Stress Disorder

NCT04197102 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-11-22

No results posted yet for this study

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=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.

Conditions

  • Post Traumatic Stress Disorder

Interventions

DRUG

CBD Isolate

A fixed dose of 300-mg of a hemp-derived formulation of purified 99.9% CBD isolate oil will be taken once daily for 8 weeks for participants randomized to the CBD Isolate arm.

OTHER

CBD Broad Spectrum

A fixed dose of 300-mg of a hemp-derived formulation of purified 99.9% CBD Broad Spectrum oil will be taken once daily for 8 weeks for participants randomized to the CBD - Broad Spectrum arm.

OTHER

Placebo oil

Placebo solution will be taken once daily for 8 weeks by participants randomized to the placebo arm.

Sponsors & Collaborators

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Michael J Telch, Ph.D. · University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2024-05-31
Completion
2025-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04197102 on ClinicalTrials.gov