Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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 : Not yet recruiting
First Posted : October 27, 2020
Last Update Posted : November 2, 2020
Sponsor:
Collaborator:
Way West Hemp 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, and placebo in in reducing COVID-Induced stress, anxiety, depression, anger, 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: Placebo Oil Phase 2 Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3-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
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: CBD-Isolate 300 mg.
Nightly 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 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

Placebo Comparator: Placebo oil
Nightly 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 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  2. PROMIS Emotional Distress Index [ Time Frame: Week 1-Treatment ]
    This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  3. PROMIS Emotional Distress Index [ Time Frame: Week 2-Treatment ]
    This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  4. PROMIS Emotional Distress Index [ Time Frame: Week 3-Treatment ]
    This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  5. PROMIS Emotional Distress Index [ Time Frame: Weeks 4-Treatment ]
    This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  6. PROMIS Emotional Distress Index [ Time Frame: Week 5-Treatment ]
    This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  7. PROMIS Emotional Distress Index [ Time Frame: Week 6-Treatment ]
    This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  8. PROMIS Emotional Distress Index [ Time Frame: Week 7-Follow-up ]
    This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).

  9. PROMIS Emotional Distress Index [ Time Frame: Week 8-Follow-up ]
    This measure is a 23-item patient-rated emotional distress symptom scale consisting of 3 sub-factors (Depression, Anxiety, and Anger). Each symptom is rated over a 7-day period on a 5-point scale ranging from 1 (Never) to 5 (Always).


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 Depression Scale [ Time Frame: Week 6-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).

  8. PROMIS Anxiety 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).

  9. PROMIS Anxiety 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).

  10. PROMIS Anxiety Scale [ Time Frame: Week 2-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 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).

  12. 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).

  13. 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).

  14. PROMIS Anxiety Scale [ Time Frame: Week 6-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).

  15. PROMIS Anger Scale [ Time Frame: Week 0 Baseline ]
    This measure is an 8-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 1 Treatment ]
    This measure is an 8-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 2 Treatment ]
    This measure is an 8-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 3 Treatment ]
    This measure is an 8-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 Anger Scale [ Time Frame: Week 4 Treatment ]
    This measure is an 8-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).

  20. PROMIS Anger Scale [ Time Frame: Week 5 Follow-up ]
    This measure is an 8-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).

  21. PROMIS Anger Scale [ Time Frame: Week 6 Follow-up ]
    This measure is an 8-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).

  22. PROMIS Alcohol Negative Consequences Scale [ Time Frame: Week 0 Baseline ]
    This measure is an 8-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 1 Treatment ]
    This measure is an 8-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 2 Treatment ]
    This measure is an 8-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 Alcohol Negative Consequences Scale [ Time Frame: Week 3 Treatment ]
    This measure is an 8-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).

  26. PROMIS Alcohol Negative Consequences Scale [ Time Frame: Week 4 Treatment ]
    This measure is an 8-item patient-rated index of substance use severity. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Almost Always).

  27. PROMIS Alcohol Negative Consequences Scale [ Time Frame: Week 5 Follow-up ]
    This measure is an 8-item patient-rated index of substance use severity. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Almost Always).

  28. PROMIS Alcohol Negative Consequences Scale [ Time Frame: Week 6 Follow-up ]
    This measure is an 8-item patient-rated index of substance use severity. Each item is rated over a 7-day period on a 5-point scale ranging from 1 (Not at all) to 5 (Almost Always).

  29. 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).

  30. 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).

  31. 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).

  32. 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).

  33. 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).

  34. 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).

  35. PROMIS Sleep Disturbance Scale [ Time Frame: Week 6 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).

  36. COVID-19 Coping Self-Efficacy [ Time Frame: Week 0 Baseline ]
    This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

  37. COVID-19 Coping Self-Efficacy [ Time Frame: Week 1 Treatment ]
    This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

  38. COVID-19 Coping Self-Efficacy [ Time Frame: Week 2 Treatment ]
    This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

  39. COVID-19 Coping Self-Efficacy [ Time Frame: Week 3 Treatment ]
    This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

  40. COVID-19 Coping Self-Efficacy [ Time Frame: Week 4 Treatment ]
    This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

  41. COVID-19 Coping Self-Efficacy [ Time Frame: Week 5 Follow-up ]
    This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy

  42. COVID-19 Coping Self-Efficacy [ Time Frame: Week 6 Follow-up ]
    This measure is a 12-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy



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 75 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;
  • Pregnant or plan to become pregnant within the next 6 weeks;
  • Currently taking blood thinners such as Warfarin;
  • Hx of adverse reactions to CBD Oil;
  • 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, B.A. (703) 343-0533‬ Cmfischer@utexas.edu

Locations
Layout table for location information
United States, Texas
University of Texas at Austin, Laboratory for the Study of Anxiety Disorders
Austin, Texas, United States, 78712
Contact: Michael J Telch, Ph.D.    512-814-5480    Telch@austin.utexas.edu   
Contact: Cate Fischer, BA    (703) 343-0533‬    cmfischer@utexas.edu   
Principal Investigator: Michael J Telch, Ph.D.         
Sponsors and Collaborators
University of Texas at Austin
Way West Hemp Inc.
Investigators
Layout table for investigator information
Principal Investigator: Michael J Telch, Ph.D. University of Texas at Austin
Publications:
Linares I, Zuardi AW, Pereira LCG, et al. Cannabidiol presents an inverted U-shaped dose-response curve in the simulated public speaking test. Eur Neuropsychopharm. 2016;26:S617. doi:10.1016/s0924-977x(16)31702-3
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: November 2, 2020
Last Verified: October 2020
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
Dyssomnias
Parasomnias
Substance-Related Disorders
Alcoholism
Fractures, Stress
Chemically-Induced Disorders
Mental Disorders
Sleep Wake Disorders
Nervous System Diseases
Alcohol-Related Disorders
Fractures, Bone
Wounds and Injuries