Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CBD Oil for Reducing Emotional Impact of COVID-19 (CBDOIL)

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: NCT04603781
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : June 7, 2022
Sponsor:
Collaborators:
Way West Wellness
SunFlora.Inc
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 relative clinical efficacy of CBD isolate, full-spectrum CBD oil, broad-spectrum CBD oil, and placebo oil in reducing COVID-induced stress (anxiety, depression, anger, substance use, and sleep disturbance).

Condition or disease Intervention/treatment Phase
Anxiety Depression Alcohol Abuse Substance Abuse Anger Sleep Disturbance Stress Reaction Dietary Supplement: CBD Isolate Dietary Supplement: Full Spectrum CBD Oil Dietary Supplement: Broad-Spectrum CBD Oil Dietary Supplement: Placebo Oil Phase 2 Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 4-arm double-blind placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of CBD Oil for Reducing the Negative Emotional Impact of COVID-19: A Randomized Placebo-Controlled Clinical Trial
Actual Study Start Date : December 4, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CBD-Isolate 300 mg.
Nightly oral administration of 300 mg. of CBD-Isolate for 28 consecutive days
Dietary Supplement: CBD Isolate
300 mg. daily dose of CBD Isolate Oil
Other Name: Pure CBD oil

Active Comparator: Full-Spectrum CBD Oil 300 mg.
Nightly oral administration of 300 mg. of Full Spectrum CBD Oil for 28 consecutive days
Dietary Supplement: Full Spectrum CBD Oil
300 mg. daily dose of CBD with full spectrum of other cannabinoids found in the hemp plant

Active Comparator: Broad-Spectrum CBD oil 300 mg.
Nightly oral administration of 300 mg. of Broad-Spectrum CBD Oil for 28 consecutive days
Dietary Supplement: Broad-Spectrum CBD Oil
300 mg. daily dose of CBD with a selected spectrum of other cannabinoids found in the hemp plant

Placebo Comparator: Placebo Oil
Nightly oral administration of 300 mg. of Placebo Oil for 28 consecutive days
Dietary Supplement: Placebo Oil
MCT Oil with mint flavoring




Primary Outcome Measures :
  1. PROMIS Emotional Distress Index [ Time Frame: Week 0-Baseline ]
    This measure is a 43-item patient-rated emotional distress symptom scale consisting of 6 sub-factors (Depression, Anxiety, Anger, Alcohol Use, Substance Use, and Sleep Disturbance). Each symptom is rated over a 7-day period on a 5-point scale.

  2. PROMIS Emotional Distress Index [ Time Frame: Week 1-Treatment ]
    This measure is a 43-item patient-rated emotional distress symptom scale consisting of 6 sub-factors (Depression, Anxiety, Anger, Alcohol Use, Substance Use, and Sleep Disturbance). Each symptom is rated over a 7-day period on a 5-point scale.

  3. PROMIS Emotional Distress Index [ Time Frame: Week 2-Treatment ]
    This measure is a 43-item patient-rated emotional distress symptom scale consisting of 6 sub-factors (Depression, Anxiety, Anger, Alcohol Use, Substance Use, and Sleep Disturbance). Each symptom is rated over a 7-day period on a 5-point scale.

  4. PROMIS Emotional Distress Index [ Time Frame: Week 3-Treatment ]
    This measure is a 43-item patient-rated emotional distress symptom scale consisting of 6 sub-factors (Depression, Anxiety, Anger, Alcohol Use, Substance Use, and Sleep Disturbance). Each symptom is rated over a 7-day period on a 5-point scale.

  5. PROMIS Emotional Distress Index [ Time Frame: Week 4-Treatment ]
    This measure is a 43-item patient-rated emotional distress symptom scale consisting of 6 sub-factors (Depression, Anxiety, Anger, Alcohol Use, Substance Use, and Sleep Disturbance). Each symptom is rated over a 7-day period on a 5-point scale.

  6. PROMIS Emotional Distress Index [ Time Frame: Week 5-Follow-up ]
    This measure is a 43-item patient-rated emotional distress symptom scale consisting of 6 sub-factors (Depression, Anxiety, Anger, Alcohol Use, Substance Use, and Sleep Disturbance). Each symptom is rated over a 7-day period on a 5-point scale.


Secondary Outcome Measures :
  1. PROMIS Depression Scale [ Time Frame: Week 0-Baseline ]
    This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  2. PROMIS Depression Scale [ Time Frame: Week 1-Treatment ]
    This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  3. PROMIS Depression Scale [ Time Frame: Week 2-Treatment ]
    This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  4. PROMIS Depression Scale [ Time Frame: Week 3-Treatment ]
    This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  5. PROMIS Depression Scale [ Time Frame: Week 4-Treatment ]
    This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  6. PROMIS Depression Scale [ Time Frame: Week 5-Follow-up ]
    This measure is an 8-item patient-rated depression symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  7. PROMIS Anxiety Scale [ Time Frame: Week 0- Baseline ]
    This measure is an 8-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  8. PROMIS Anxiety Scale [ Time Frame: Week 1-Treatment ]
    This measure is an 8-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  9. PROMIS Anxiety Scale [ Time Frame: Week 2-Treatment ]
    This measure is an 8-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  10. PROMIS Anxiety Scale [ Time Frame: Week 3-Treatment ]
    This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  11. PROMIS Anxiety Scale [ Time Frame: Week 4-Treatment ]
    This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  12. PROMIS Anxiety Scale [ Time Frame: Week 5-Follow-up ]
    This measure is a 7-item patient-rated anxiety symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  13. PROMIS Anger Scale [ Time Frame: Week 0- Baseline ]
    This measure is a 5-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  14. PROMIS Anger Scale [ Time Frame: Week 1- Treatment ]
    This measure is a 5-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  15. PROMIS Anger Scale [ Time Frame: Week 2- Treatment ]
    This measure is a 5-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  16. PROMIS Anger Scale [ Time Frame: Week 3- Treatment ]
    This measure is a 5-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  17. PROMIS Anger Scale [ Time Frame: Week 4- Treatment ]
    This measure is a 5-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  18. PROMIS Anger Scale [ Time Frame: Week 5- Follow-up ]
    This measure is a 5-item patient-rated anger symptom scale. Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  19. PROMIS Alcohol Negative Consequences Scale [ Time Frame: Week 0- Baseline ]
    This measure is a 7-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  20. PROMIS Alcohol Negative Consequences Scale [ Time Frame: Week 1- Treatment ]
    This measure is a 7-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  21. PROMIS Alcohol Negative Consequences Scale [ Time Frame: Week 2- Treatment ]
    This measure is a 7-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  22. PROMIS Alcohol Negative Consequences Scale [ Time Frame: Week 3- Treatment ]
    This measure is a 7-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  23. PROMIS Alcohol Negative Consequences Scale [ Time Frame: Week 4- Treatment ]
    This measure is a 7-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  24. PROMIS Alcohol Negative Consequences Scale [ Time Frame: Week 5- Follow-up ]
    This measure is a 7-item patient-rated index of alcohol-related problems. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  25. PROMIS Sleep Disturbance Scale [ Time Frame: Week 0- Baseline ]
    This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).

  26. PROMIS Sleep Disturbance Scale [ Time Frame: Week 1- Treatment ]
    This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).

  27. PROMIS Sleep Disturbance Scale [ Time Frame: Week 2- Treatment ]
    This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).

  28. PROMIS Sleep Disturbance Scale [ Time Frame: Week 3- Treatment ]
    This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).

  29. PROMIS Sleep Disturbance Scale [ Time Frame: Week 4- Treatment ]
    This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).

  30. PROMIS Sleep Disturbance Scale [ Time Frame: Week 5- Follow-up ]
    This measure is an 8-item patient-rated index of sleep disturbance. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Very Much).

  31. COVID-19 Coping Self-Efficacy [ Time Frame: Week 0- Baseline ]
    This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

  32. COVID-19 Coping Self-Efficacy [ Time Frame: Week 1- Treatment ]
    This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

  33. COVID-19 Coping Self-Efficacy [ Time Frame: Week 2- Treatment ]
    This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

  34. COVID-19 Coping Self-Efficacy [ Time Frame: Week 3- Treatment ]
    This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

  35. COVID-19 Coping Self-Efficacy [ Time Frame: Week 4- Treatment ]
    This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

  36. COVID-19 Coping Self-Efficacy [ Time Frame: Week 5- Follow-up ]
    This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

  37. Sheehan Disability Scale [ Time Frame: Week 0- Baseline ]
    This measure is a 3-item patient-rated index of level of functional impairment.

  38. Sheehan Disability Scale [ Time Frame: Week 5- Follow-up ]
    This measure is a 3-item patient-rated index of level of functional impairment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

INCLUSION CRITERIA:

  • Displays elevated symptom scores on one or more of the following established assessment instruments for depression (PROMIS-Depression), anxiety (PROMIS-Anxiety), Anger (PROMIS-Anger), sleep disturbance (PROMIS-Sleep); or Alcohol/Substance (PROMIS-Alcohol; PROMIS- Substance Use)
  • Age between 18 to 70;
  • Fluent in English;
  • Has home access to the Internet;
  • Willingness to provide signed informed consent;
  • Willingness to refrain from all non-study CBD products during the 6-week study period;
  • Willing to complete a brief pre-study 7-day online symptom monitoring log;

EXCLUSION CRITERIA:

  • History of a suicide attempt in the past 6 months;
  • Current medical problems that would preclude participating in the study including liver disease, current use of blood thinners, seizure medications, thyroid medications, or heart rhythm medications;
  • Pregnant or plan to become pregnant within the next 6 weeks;
  • Hx of adverse reactions to CBD oil or other CBD products;
  • Allergic to coconut oil.

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): NCT04603781


Contacts
Layout table for location contacts
Contact: Michael J Telch, Ph.D. (512) 814-5480 Telch@austin.utexas.edu
Contact: Cate Fischer, M.A. (512) 522-6216 utcbdstudy@gmail.com

Locations
Layout table for location information
United States, Texas
University of Texas at Austin, Laboratory for the Study of Anxiety Disorders Recruiting
Austin, Texas, United States, 78712
Contact: Michael J Telch, Ph.D.    512-814-5480    Telch@austin.utexas.edu   
Contact: Cate Fischer, MA    (512) 522-6216    utcbdstudy@gmail.com   
Principal Investigator: Michael J Telch, Ph.D.         
Sponsors and Collaborators
University of Texas at Austin
Way West Wellness
SunFlora.Inc
Investigators
Layout table for investigator information
Principal Investigator: Michael J Telch, Ph.D. University of Texas at Austin
Publications:
Gallily R, Yekhtin Z, Hanuš LO. Overcoming the Bell-Shaped Dose-Response of Cannabidiol by Using <i>Cannabis</i> Extract Enriched in Cannabidiol. Pharmacol Amp Pharm. 2015;06(02):75-85. doi:10.4236/pp.2015.62010

Layout table for additonal information
Responsible Party: Michael J. Telch, Principal Investigator, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT04603781    
Other Study ID Numbers: 2020-07-0138
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
CBD Oil
CBD Isolate
COVID-19
stress symptoms
RCT
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Dyssomnias
Parasomnias
Substance-Related Disorders
Alcoholism
Fractures, Stress
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Chemically-Induced Disorders
Mental Disorders
Sleep Wake Disorders
Nervous System Diseases
Alcohol-Related Disorders
Fractures, Bone
Wounds and Injuries