CBD Oil for Reducing Emotional Impact of COVID-19

NCT04603781 | Suspended Phase 2

• 1 other identifier: 2020-07-0138
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Our purpose is to conduct a 4-arm placebo-controlled clinical trial to investigate the relative clinical efficacy of 300 mg. of pure hemp-derived CBD isolate, 300 mg. of full spectrum CBD oil, 300 mg. of broad- spectrum CBD Oil, or Placebo oil among adults presenting with COVID-19 -induced stress reactions including one or more of the following: anxiety, depression, anger, substance use, or sleep disturbance.

Conditions

Anxiety Depression; Alcohol Abuse; Substance Abuse; Anger; Sleep Disturbance; Stress Reaction

Keywords

CBD Oil; CBD Isolate; COVID-19; stress symptoms; RCT

Outcome Measures

Primary Outcomes (6)

• PROMIS Emotional Distress Index

  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.

  Week 0-Baseline

• PROMIS Emotional Distress Index

  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.

  Week 1-Treatment

• PROMIS Emotional Distress Index

  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.

  Week 2-Treatment

• PROMIS Emotional Distress Index

  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.

  Week 3-Treatment

• PROMIS Emotional Distress Index

  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.

  Week 4-Treatment

• PROMIS Emotional Distress Index

  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.

  Week 5-Follow-up

Secondary Outcomes (38)

• PROMIS Depression Scale

  Week 0-Baseline

• PROMIS Depression Scale

  Week 1-Treatment

• PROMIS Depression Scale

  Week 2-Treatment

• PROMIS Depression Scale

  Week 3-Treatment

• PROMIS Depression Scale

  Week 4-Treatment

Study Arms (4)

CBD-Isolate 300 mg.

ACTIVE COMPARATOR

Nightly oral administration of 300 mg. of CBD-Isolate for 28 consecutive days

Dietary Supplement: CBD Isolate

Full-Spectrum CBD Oil 300 mg.

ACTIVE COMPARATOR

Nightly oral administration of 300 mg. of Full Spectrum CBD Oil for 28 consecutive days

Dietary Supplement: Full Spectrum CBD Oil

Broad-Spectrum CBD oil 300 mg.

ACTIVE COMPARATOR

Nightly oral administration of 300 mg. of Broad-Spectrum CBD Oil for 28 consecutive days

Dietary Supplement: Broad-Spectrum CBD Oil

Placebo Oil

PLACEBO COMPARATOR

Nightly oral administration of 300 mg. of Placebo Oil for 28 consecutive days

Dietary Supplement: Placebo Oil

Interventions

CBD Isolate DIETARY_SUPPLEMENT

300 mg. daily dose of CBD Isolate Oil

Also known as: Pure CBD oil

CBD-Isolate 300 mg.

Full Spectrum CBD Oil DIETARY_SUPPLEMENT

300 mg. daily dose of CBD with full spectrum of other cannabinoids found in the hemp plant

Full-Spectrum CBD Oil 300 mg.

Broad-Spectrum CBD Oil DIETARY_SUPPLEMENT

300 mg. daily dose of CBD with a selected spectrum of other cannabinoids found in the hemp plant

Broad-Spectrum CBD oil 300 mg.

Placebo Oil DIETARY_SUPPLEMENT

MCT Oil with mint flavoring

Placebo Oil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Currently residing in the United States

You may not qualify if:

• History of a suicide attempt within the past 6 months
• Any medical problem that would preclude participating in the study including liver disease
• Current use of warfarin or other prescribed blood thinners,
• Currently taking seizure medications such as valproate, lamotrigine, or clobazam;
• Currently taking thyroid medications such as levothyroxine;
• Currently taking heart rhythm medications such as amiodarone;
• Currently taking anti-hypertension medications;
• Pregnant or planning to become pregnant within the next 6 weeks.
• History of adverse reaction to CBD oil or other CBD products.
• Allergic to coconut oil.

Sponsors & Collaborators

• University of Texas at Austin: lead
• Way West Wellness: collaborator
• SunFlora.Inc: collaborator

Study Sites (1)

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

Austin, Texas, 78712, United States

Location

Related Publications (14)

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  BACKGROUND

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MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders; Parasomnias; Fractures, Stress; COVID-19

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Fractures, Bone; Wounds and Injuries; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

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: The PI and all members of the study team will be blind to the drug assignment of the patient. Only the CBD suppliers (John Fornecker- Way West and Anthony Ferrari - SunMed CBD) and a UT LSAD staff member (not connected to the study) will have access to participants' treatment assignment. In the very unlikely event that a participant should have an adverse reaction requiring medical attention, the PI will contact the UT staff person who is keeper of the blind and request the treatment assignment of the subject in question without revealing the treatment condition coding scheme.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 4-arm double-blind placebo-controlled trial

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: October 27, 2020
• Study Start: December 4, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)