CBD Oil for Reducing Emotional Impact of COVID-19 (NCT04603781) | Clinical Trial Compass
SuspendedPhase 2/3
CBD Oil for Reducing Emotional Impact of COVID-19
Stopped: Suspended (The UT IRB determined that CBD oil is being used as a drug as defined by the FDA. Therefore, an IND must be obtained for the use of CBD oil in this research study in accordance with FDA regulations, 21 CFR 312.)
United States200 participantsStarted 2020-12-04
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
* Currently residing in the United States
EXCLUSION CRITERIA:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.