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Use of CBD Oil in the Treatment of Posttraumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04197102
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Michael J. Telch, University of Texas at Austin

Brief 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.


Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Drug: Cannabidiol (CBD) oil Other: Placebo oil Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Each nightly dose of CBD/Placebo oil will be tagged with a code # on the plastic syringe containing the CBD oil or placebo oil. Both 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.
Primary Purpose: Treatment
Official Title: Use of Cannabidiol (CBD) Oil in the Treatment of PTSD: A Placebo-Controlled Randomized Clinical Trial
Actual Study Start Date : January 15, 2020
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CBD oil
300 mg/day of CBD isolate
Drug: Cannabidiol (CBD) oil
A fixed dose of 300-mg of a hemp-derived formulation of purified 99.9% cannabidiol oil will be taken once daily for 8 weeks for participants randomized to the CBD arm.
Other Name: CBD

Placebo Comparator: Placebo oil
300 mg/day of placebo oil
Other: Placebo oil
Placebo solution will be taken once daily for 8 weeks by participants randomized to the placebo arm.
Other Name: PLBO




Primary Outcome Measures :
  1. CAPS-5 [ Time Frame: Post-treatment (week 9), one month (week 13), and three month (week 21) follow-up assessments ]
    Change from baseline in clinician-rated PTSD severity.

  2. CGI [ Time Frame: Post-treatment (week 9), one month (week 13), and three month (week 21) follow-up assessments ]
    Change from baseline in clinician-rated global impressions.


Secondary Outcome Measures :
  1. PCL-5 [ Time Frame: Post-treatment (week 9), one month (week 13), and three month (week 21) follow-up assessments ]
    Change from baseline in patient-rated symptoms of PTSD.

  2. QIDS [ Time Frame: Post-treatment (week 9), one month (week 13), and three month (week 21) follow-up assessments ]
    Change from baseline in patient-rated symptoms of depression.

  3. SDS [ Time Frame: Post-treatment (week 9), one month (week 13), and three month (week 21) follow-up assessments ]
    Change from baseline in overall disability.

  4. WHOQOL-BREF [ Time Frame: Post-treatment (week 9), one month (week 13), and three month (week 21) follow-up assessments ]
    Change from baseline in quality of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meets for a current DSM-5 diagnosis of PTSD as their "primary" mental disorder
  2. Age between 18 to 70
  3. Fluent in English
  4. Able to arrange transportation to our laboratory
  5. Has access to the internet
  6. Willingness to provide signed informed consent
  7. 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 with 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197102


Contacts
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Contact: Michael J. Telch, PhD 5125604100 telch@austin.utexas.edu

Locations
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United States, Texas
Laboratory for the Study of Anxiety Disorders, University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Michael J Telch, Ph.D.    512-967-1074    Telch@austin.utexas.edu   
Principal Investigator: Michael J Telch, Ph.D.         
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Michael J Telch, Ph.D. University of Texas at Austin
Publications:
Powers, M., Halpern, J., Ferenschak, M., Gillihan, S., Foa, E. (2013). A Meta-Analytic Review of Prolonged Exposure for Posttraumatic Stress Disorder FOCUS 11(3), 428-436. https://dx.doi.org/10.1176/appi.focus.11.3.428

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Responsible Party: Michael J. Telch, Professor of Psychology, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT04197102    
Other Study ID Numbers: 2019-05-0123
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael J. Telch, University of Texas at Austin:
PTSD, CBD, cannabidiol, home-based study
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Epidiolex
Anticonvulsants