Use of CBD Oil in the Treatment of Posttraumatic Stress Disorder

NCT04197102 | Suspended Phase 2

• 1 other identifier: 2019-05-0123
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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=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

Keywords

PTSD, CBD, cannabidiol, home-based study

Outcome Measures

Primary Outcomes (1)

• PCL-5

  Change from baseline in patient-rated symptoms of PTSD.

  Post-treatment (week 9) and one month (week 13) follow-up assessments

Secondary Outcomes (5)

• PHQ-9

  Post-treatment (week 9) and one month (week 13) follow-up assessments

• SDS

  Post-treatment (week 9) and one month (week 13) follow-up assessments

• WHOQOL-BREF

  Post-treatment (week 9) and one month (week 13) follow-up assessments

• GAD-7

  Post-treatment (week 9) and one month (week 13) follow-up assessments

• PROMIS Alcohol Use -Short Form

  Post-treatment (week 9) and one month (week 13) follow-up assessments

Study Arms (3)

CBD Isolate

ACTIVE COMPARATOR

300 mg/day of CBD isolate

Drug: CBD Isolate

CBD Broad Spectrum

ACTIVE COMPARATOR

300 mg/day of CBD Broad Spectrum Oil

Other: CBD Broad Spectrum

Placebo oil

PLACEBO COMPARATOR

Matched Placebo Oil

Other: Placebo oil

Interventions

CBD Isolate DRUG

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.

Also known as: CBD Isolate Oil

CBD Isolate

CBD Broad Spectrum OTHER

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.

Also known as: CBD Broad Spectrum Oil

CBD Broad Spectrum

Placebo oil OTHER

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

Also known as: PLBO

Placebo oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets for a current DSM-5 diagnosis of PTSD as their "primary" mental disorder
• Age 18 or older
• Fluent in English
• Has access to the internet
• Willingness to provide signed informed consent
• Willingness to refrain from all non-study cannabis use during the study period

You may not qualify if:

• History of a suicide attempt within the past 6 months
• History of psychosis within the past 6 months
• History of current alcohol or substance use disorder within the past month
• Any medical problems that would preclude participating in the study
• History of adverse reaction to CBD oil or other CBD products
• Allergy to coconut oil

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Laboratory for the Study of Anxiety Disorders, University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (14)

• Shalev AY, Gevonden M, Ratanatharathorn A, Laska E, van der Mei WF, Qi W, Lowe S, Lai BS, Bryant RA, Delahanty D, Matsuoka YJ, Olff M, Schnyder U, Seedat S, deRoon-Cassini TA, Kessler RC, Koenen KC; International Consortium to Predict PTSD. Estimating the risk of PTSD in recent trauma survivors: results of the International Consortium to Predict PTSD (ICPP). World Psychiatry. 2019 Feb;18(1):77-87. doi: 10.1002/wps.20608.

  PMID: 30600620 BACKGROUND

• Powers MB, Gillihan SJ, Rosenfield D, Jerud AB, Foa EB. Reliability and validity of the PDS and PSS-I among participants with PTSD and alcohol dependence. J Anxiety Disord. 2012 Jun;26(5):617-23. doi: 10.1016/j.janxdis.2012.02.013. Epub 2012 Mar 3.

  PMID: 22480715 BACKGROUND

• Merikangas KR, Akiskal HS, Angst J, Greenberg PE, Hirschfeld RM, Petukhova M, Kessler RC. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey replication. Arch Gen Psychiatry. 2007 May;64(5):543-52. doi: 10.1001/archpsyc.64.5.543.

  PMID: 17485606 BACKGROUND

• Powers MB, Halpern JM, Ferenschak MP, Gillihan SJ, Foa EB. A meta-analytic review of prolonged exposure for posttraumatic stress disorder. Clin Psychol Rev. 2010 Aug;30(6):635-41. doi: 10.1016/j.cpr.2010.04.007. Epub 2010 May 2.

  PMID: 20546985 BACKGROUND

• White CM. A Review of Human Studies Assessing Cannabidiol's (CBD) Therapeutic Actions and Potential. J Clin Pharmacol. 2019 Jul;59(7):923-934. doi: 10.1002/jcph.1387. Epub 2019 Feb 7.

  PMID: 30730563 BACKGROUND

• Devinsky O, Cross JH, Laux L, Marsh E, Miller I, Nabbout R, Scheffer IE, Thiele EA, Wright S; Cannabidiol in Dravet Syndrome Study Group. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome. N Engl J Med. 2017 May 25;376(21):2011-2020. doi: 10.1056/NEJMoa1611618.

  PMID: 28538134 BACKGROUND

• Devinsky O, Patel AD, Cross JH, Villanueva V, Wirrell EC, Privitera M, Greenwood SM, Roberts C, Checketts D, VanLandingham KE, Zuberi SM; GWPCARE3 Study Group. Effect of Cannabidiol on Drop Seizures in the Lennox-Gastaut Syndrome. N Engl J Med. 2018 May 17;378(20):1888-1897. doi: 10.1056/NEJMoa1714631.

  PMID: 29768152 BACKGROUND

• McGuire P, Robson P, Cubala WJ, Vasile D, Morrison PD, Barron R, Taylor A, Wright S. Cannabidiol (CBD) as an Adjunctive Therapy in Schizophrenia: A Multicenter Randomized Controlled Trial. Am J Psychiatry. 2018 Mar 1;175(3):225-231. doi: 10.1176/appi.ajp.2017.17030325. Epub 2017 Dec 15.

  PMID: 29241357 BACKGROUND

• Bergamaschi MM, Queiroz RH, Chagas MH, de Oliveira DC, De Martinis BS, Kapczinski F, Quevedo J, Roesler R, Schroder N, Nardi AE, Martin-Santos R, Hallak JE, Zuardi AW, Crippa JA. Cannabidiol reduces the anxiety induced by simulated public speaking in treatment-naive social phobia patients. Neuropsychopharmacology. 2011 May;36(6):1219-26. doi: 10.1038/npp.2011.6. Epub 2011 Feb 9.

  PMID: 21307846 BACKGROUND

• Berk M, Ng F, Dodd S, Callaly T, Campbell S, Bernardo M, Trauer T. The validity of the CGI severity and improvement scales as measures of clinical effectiveness suitable for routine clinical use. J Eval Clin Pract. 2008 Dec;14(6):979-83. doi: 10.1111/j.1365-2753.2007.00921.x. Epub 2008 May 2.

  PMID: 18462279 BACKGROUND

• Pinto-Meza A, Serrano-Blanco A, Penarrubia MT, Blanco E, Haro JM. Assessing depression in primary care with the PHQ-9: can it be carried out over the telephone? J Gen Intern Med. 2005 Aug;20(8):738-42. doi: 10.1111/j.1525-1497.2005.0144.x.

  PMID: 16050884 BACKGROUND

• Leon AC, Olfson M, Portera L, Farber L, Sheehan DV. Assessing psychiatric impairment in primary care with the Sheehan Disability Scale. Int J Psychiatry Med. 1997;27(2):93-105. doi: 10.2190/T8EM-C8YH-373N-1UWD.

  PMID: 9565717 BACKGROUND

• Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.

  PMID: 9626712 BACKGROUND

• Telch MJ, Fischer CM, Zaizar ED, Rubin M, Papini S. Use of Cannabidiol (CBD) oil in the treatment of PTSD: Study design and rationale for a placebo-controlled randomized clinical trial. Contemp Clin Trials. 2022 Nov;122:106933. doi: 10.1016/j.cct.2022.106933. Epub 2022 Sep 22.

  PMID: 36154908 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Color Vision Defects

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael J Telch, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 12, 2019
• Study Start: January 15, 2020
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)