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 range18 Years – 70 Years

SexALL

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.

What they're measuring

PROMIS Emotional Distress Index

Timeframe: Week 0-Baseline

PROMIS Emotional Distress Index

Timeframe: Week 1-Treatment

PROMIS Emotional Distress Index

Timeframe: Week 2-Treatment

PROMIS Emotional Distress Index

Timeframe: Week 3-Treatment

PROMIS Emotional Distress Index

Timeframe: Week 4-Treatment

PROMIS Emotional Distress Index

Timeframe: Week 5-Follow-up

Trial details

NCT IDNCT04603781

SponsorUniversity of Texas at Austin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Anxiety Depression trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

PROMIS Emotional Distress Index

Timeframe: Week 0-Baseline

PROMIS Emotional Distress Index

Timeframe: Week 1-Treatment

PROMIS Emotional Distress Index

Timeframe: Week 2-Treatment

PROMIS Emotional Distress Index

Timeframe: Week 3-Treatment

PROMIS Emotional Distress Index

Timeframe: Week 4-Treatment

PROMIS Emotional Distress Index

Timeframe: Week 5-Follow-up