Anxiety DepressionPhase 2/3CBDOILNCT04603781
CBD Oil for Reducing Emotional Impact of COVID-19
A Phase 2/3 study testing CBD Isolate, Full Spectrum CBD Oil and Broad-Spectrum CBD Oil in people with Anxiety Depression and Alcohol Abuse, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Depression, Alcohol Abuse, Substance Abuse
- What is being tested?
- CBD Isolate, Full Spectrum CBD Oil and Broad-Spectrum CBD Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2020to 31 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Austin, Laboratory for the Study of Anxiety Disorders
Austin, Texas, 78712
About this study
Official title: Use of CBD Oil for Reducing the Negative Emotional Impact of COVID-19: A Randomized Placebo-Controlled Clinical Trial
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.
Read the detailed description
Background and Significance of the Proposed Project
The COVID-19 pandemic has hit us like a ton of bricks creating unimaginable levels of unanticipated death, financial hardship, and dramatic changes in nearly every facet of our life including school, work, shopping, social and family life. Sadly, the physical, mental, economic, and health burden of COVID-19 disproportionately affects the poor, the elderly, and people of color.
The stress induced by these changes as well as the lack of control we have over them increases risk for new onset of mental health problems such as anxiety, depression, substance abuse, sleep disturbance, and family violence as well as exacerbation of symptoms among those with pre-existing psychiatric conditions. Although many people will successfully manage the increased stress from COVID-19 on their own or with the support from family and friends, others may need extra help to cope. Consequently, there is an urgent need for developing cost-effective strategies for managing the stress-induced psychological consequences of COVID-19.
There's been considerable excitement in the press over the potential therapeutic use of cannabidiol (CBD) products in the treatment of a variety of physical and mental health problems. Delta-9-tetrahydrocannabinol (delta-9 THC) is still illegal in most states because of its psychoactive abuse potential. In contrast, cannabidiol (CBD) does not convert to THC in the body and has negligible side effects relative to main-stream psychiatric drugs (benzodiazepines and antidepressants) commonly prescribed for the treatment of stress-related disorders such as anxiety, depression, and insomnia. Mounting evidence from studies with rodents suggests that CBD may confer significant promising health-related benefits including anti-inflammatory, pain-relieving, anti-cancer, memory enhancement, and facilitation of fear extinction (see White for a recent review).
The biggest success story for CBD use in humans to date comes from placebo-controlled randomized clinical trials demonstrating a 50% or more reduction in previously intractable seizures in children suffering from Dravet syndrome and Lennox-Gastaut syndrome. Moreover, several controlled clinical trials have shown promising findings in reducing psychotic symptoms among patients with schizophrenia and among young adults displaying THC-induced psychosis.
Preliminary Evidence that CBD may offer promise in the treatment of stress-related disorders has started to emerge. A small pilot trial with 24 patients presenting with social anxiety disorder found that relative to placebo, a single dose of 100 mg of CBD oil led to lower levels of anxiety, cognitive impairment, and discomfort in their actual speech performance as well as their anxiety before the speech. An uncontrolled case series of 11 PTSD patients receiving 8 weeks of CBD, reported a 28% reduction in PTSD symptom scores. In a small 4-week placebo-controlled study of 37 young Japanese adults with social anxiety disorder, Masataka found a significant advantage of CBD over placebo in reducing subjects' scores on two widely used measures of social anxiety symptoms.
Why Compare CBD-Isolate with Broad-Spectrum and Full-Spectrum CBD? CBD isolate is the purest form of CBD. It is made by extracting it from its natural environment - either hemp which is legal and recognized as generally safe in all states because of its low THC content (less than .3%), or the marijuana plant which has high levels of THC (up to 30%) and remains a Schedule 1 controlled substance under the Controlled Substances Act of 1970.
Unlike hemp-derived CBD Isolate, hemp-derived full-spectrum CBD contains all the hundreds of phytochemicals naturally found in the cannabis plant, including CBD, trace cannabinoids including Cannabinol (CBN), Cannabichromene (CBC), Cannabigerol (CBDA) and Cannabidivarin (CBDV), and more than 200 different terpenes, essential oils, and negligible THC content (less than 0.3%).
Research demonstrating the wide-ranging therapeutic effects of CBD oil including anti-emetic, anti-inflammatory, anxiolytic, and anti-psychotic effects were based on studies using pure doses of CBD Isolate. However, more recently it has been shown that the therapeutic effects of purified CBD display a bell-shaped dose-response curve suggesting a limited dose range, with no beneficial effects achieved at either lower or higher doses. This narrow therapeutic window presents a challenge for using CBD isolate clinically.
Based on recent research with rodents and humans, administration of a full spectrum cannabis extract containing mostly CBD but also containing other minor phytocannabinoids and non-cannabinoids exerted a synergistic effect with CBD that was both more effective than CBD Isolate without the unwanted bell-shaped dose-response curve. This finding has been named the entourage effect. However, to date, there are no human trials for any physical or mental health problem comparing the gold standard CBD isolate with a full-spectrum CBD formulation, despite the fact that both forms of CBD are widely available without a prescription in stores all across the United States. The proposed project will provide important data to determine whether a full-spectrum CBD formulation offers any advantages over CBD isolate in reducing COVID-19 stress-induced symptoms.
Specific Aims and Hypotheses:
- Compare the efficacy of a 4-week daily regimen of hemp-derived CBD isolate (300 mg/day), broad-spectrum CBD oil, full spectrum CBD oil (300 mg/day), or placebo oil in reducing patient-rated symptoms of stress, anxiety, depression, and sleep disturbance. It is predicted that patients receiving and of the three active CBD oil formulations (pure isolate, broad-spectrum, or full spectrum CBD oil) will show significantly greater reduction in emotional distress and sleep disturbance relative to those receiving placebo oil. It is also predicted that broad-spectrum and full-spectrum CBD oil will outperform CBD isolate in reducing COVID-19 stress-induced symptoms of stress, anxiety, depression, anger, and sleep disturbance.
- Examine predictors of patients' clinical response to the 4 treatments. It is expected that the superiority of broad-spectrum and full-spectrum CBD oil relative to CBD isolate or placebo will be more pronounced for patients showing more severe COVID-19 stress-induced symptoms at baseline.
- Examine the perceived acceptability and side effects profile of 4 weeks of daily CBD/Placebo oil ingestion. It is expected that each of the three CBD formulations (CBD isolate, Broad-spectrum or Full spectrum CBD oil) will show minimal side effects that will not exceed the level of side effects for those ingesting placebo oil with the possible exception of somnolence.
- Conditions
- Anxiety Depression, Alcohol Abuse, Substance Abuse, Anger, Sleep Disturbance, Stress Reaction
- Being tested
- CBD Isolate, Full Spectrum CBD Oil, Broad-Spectrum CBD Oil, Placebo Oil
- Keywords
- CBD Oil, CBD Isolate, COVID-19, stress symptoms, RCT
- Medical subject headings
- Alcoholism, Substance-Related Disorders, Parasomnias, Fractures, Stress, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD IsolateDietary supplement
Also called Pure CBD oil
300 mg. daily dose of CBD Isolate Oil
Full Spectrum CBD OilDietary supplement
300 mg. daily dose of CBD with full spectrum of other cannabinoids found in the hemp plant
Broad-Spectrum CBD OilDietary supplement
300 mg. daily dose of CBD with a selected spectrum of other cannabinoids found in the hemp plant
Placebo OilDietary supplement
MCT Oil with mint flavoring
| Study group | Role | What they receive |
|---|---|---|
| CBD-Isolate 300 mg. | Active comparator | Nightly oral administration of 300 mg. of CBD-Isolate for 28 consecutive days Receives: 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 Receives: 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 Receives: Dietary Supplement: Broad-Spectrum CBD Oil |
| Placebo Oil | Placebo comparator | Nightly oral administration of 300 mg. of Placebo Oil for 28 consecutive days Receives: Dietary Supplement: Placebo Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 5-Follow-up
Secondary outcomes (38)
PROMIS Depression Scale
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).
Measured: Week 0-Baseline
PROMIS Depression Scale
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).
Measured: Week 1-Treatment
PROMIS Depression Scale
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).
Measured: Week 2-Treatment
PROMIS Depression Scale
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).
Measured: Week 3-Treatment
PROMIS Depression Scale
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).
Measured: Week 4-Treatment
PROMIS Depression Scale
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).
Measured: Week 5-Follow-up
PROMIS Anxiety Scale
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).
Measured: Week 0- Baseline
PROMIS Anxiety Scale
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).
Measured: Week 1-Treatment
PROMIS Anxiety Scale
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).
Measured: Week 2-Treatment
PROMIS Anxiety Scale
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).
Measured: Week 3-Treatment
PROMIS Anxiety Scale
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).
Measured: Week 4-Treatment
PROMIS Anxiety Scale
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).
Measured: Week 5-Follow-up
PROMIS Anger Scale
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).
Measured: Week 0- Baseline
PROMIS Anger Scale
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).
Measured: Week 1- Treatment
PROMIS Anger Scale
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).
Measured: Week 2- Treatment
PROMIS Anger Scale
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).
Measured: Week 3- Treatment
PROMIS Anger Scale
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).
Measured: Week 4- Treatment
PROMIS Anger Scale
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).
Measured: Week 5- Follow-up
PROMIS Alcohol Negative Consequences Scale
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).
Measured: Week 0- Baseline
PROMIS Alcohol Negative Consequences Scale
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).
Measured: Week 1- Treatment
PROMIS Alcohol Negative Consequences Scale
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).
Measured: Week 2- Treatment
PROMIS Alcohol Negative Consequences Scale
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).
Measured: Week 3- Treatment
PROMIS Alcohol Negative Consequences Scale
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).
Measured: Week 4- Treatment
PROMIS Alcohol Negative Consequences Scale
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).
Measured: Week 5- Follow-up
PROMIS Sleep Disturbance Scale
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).
Measured: Week 0- Baseline
PROMIS Sleep Disturbance Scale
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).
Measured: Week 1- Treatment
PROMIS Sleep Disturbance Scale
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).
Measured: Week 2- Treatment
PROMIS Sleep Disturbance Scale
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).
Measured: Week 3- Treatment
PROMIS Sleep Disturbance Scale
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).
Measured: Week 4- Treatment
PROMIS Sleep Disturbance Scale
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).
Measured: Week 5- Follow-up
COVID-19 Coping Self-Efficacy
This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy
Measured: Week 0- Baseline
COVID-19 Coping Self-Efficacy
This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy
Measured: Week 1- Treatment
COVID-19 Coping Self-Efficacy
This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy
Measured: Week 2- Treatment
COVID-19 Coping Self-Efficacy
This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy
Measured: Week 3- Treatment
COVID-19 Coping Self-Efficacy
This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy
Measured: Week 4- Treatment
COVID-19 Coping Self-Efficacy
This measure is a 15-item author-constructed patient-rated index of COVID-19 Coping Self-Efficacy
Measured: Week 5- Follow-up
Sheehan Disability Scale
This measure is a 3-item patient-rated index of level of functional impairment.
Measured: Week 0- Baseline
Sheehan Disability Scale
This measure is a 3-item patient-rated index of level of functional impairment.
Measured: Week 5- Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start4 Dec 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it 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.)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4-arm double-blind placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Way West Wellness, SunFlora.Inc
- Responsible party
- Principal investigator, Michael J. Telch, University of Texas at Austin
- Investigators
- Michael J Telch, Ph.D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603781
- Sponsor's protocol ID
- 2020-07-0138
- Acronym
- CBDOIL
- Status last verified
- Nov 2023
- First submitted
- 3 Oct 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cowger TL, Davis BA, Etkins OS, Makofane K, Lawrence JA, Bassett MT, Krieger N. Comparison of Weighted and Unweighted Population Data to Assess Inequities in Coronavirus Disease 2019 Deaths by Race/Ethnicity Reported by the US Centers for Disease Control and Prevention. JAMA Netw Open. 2020 Jul 1;3(7):e2016933. doi: 10.1001/jamanetworkopen.2020.16933.
PubMed 32721026Mazza C, Ricci E, Biondi S, Colasanti M, Ferracuti S, Napoli C, Roma P. A Nationwide Survey of Psychological Distress among Italian People during the COVID-19 Pandemic: Immediate Psychological Responses and Associated Factors. Int J Environ Res Public Health. 2020 May 2;17(9):3165. doi: 10.3390/ijerph17093165.
PubMed 32370116White CM. A Review of Human Studies Assessing Cannabidiol's (CBD) Therapeutic Actions and Potential. J Clin Pharmacol. 2019 Jul;59(7):923-934. doi: 10.1002/jcph.1387. Epub 2019 Feb 7.
PubMed 30730563Devinsky O, Cross JH, Laux L, Marsh E, Miller I, Nabbout R, Scheffer IE, Thiele EA, Wright S; Cannabidiol in Dravet Syndrome Study Group. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome. N Engl J Med. 2017 May 25;376(21):2011-2020. doi: 10.1056/NEJMoa1611618.
PubMed 28538134Devinsky O, Patel AD, Cross JH, Villanueva V, Wirrell EC, Privitera M, Greenwood SM, Roberts C, Checketts D, VanLandingham KE, Zuberi SM; GWPCARE3 Study Group. Effect of Cannabidiol on Drop Seizures in the Lennox-Gastaut Syndrome. N Engl J Med. 2018 May 17;378(20):1888-1897. doi: 10.1056/NEJMoa1714631.
PubMed 29768152McGuire P, Robson P, Cubala WJ, Vasile D, Morrison PD, Barron R, Taylor A, Wright S. Cannabidiol (CBD) as an Adjunctive Therapy in Schizophrenia: A Multicenter Randomized Controlled Trial. Am J Psychiatry. 2018 Mar 1;175(3):225-231. doi: 10.1176/appi.ajp.2017.17030325. Epub 2017 Dec 15.
PubMed 29241357Zuardi AW, Hallak JE, Dursun SM, Morais SL, Sanches RF, Musty RE, Crippa JA. Cannabidiol monotherapy for treatment-resistant schizophrenia. J Psychopharmacol. 2006 Sep;20(5):683-6. doi: 10.1177/0269881106060967. Epub 2006 Jan 9.
PubMed 16401651Morgan CJ, Curran HV. Effects of cannabidiol on schizophrenia-like symptoms in people who use cannabis. Br J Psychiatry. 2008 Apr;192(4):306-7. doi: 10.1192/bjp.bp.107.046649.
PubMed 18378995Bergamaschi MM, Queiroz RH, Chagas MH, de Oliveira DC, De Martinis BS, Kapczinski F, Quevedo J, Roesler R, Schroder N, Nardi AE, Martin-Santos R, Hallak JE, Zuardi AW, Crippa JA. Cannabidiol reduces the anxiety induced by simulated public speaking in treatment-naive social phobia patients. Neuropsychopharmacology. 2011 May;36(6):1219-26. doi: 10.1038/npp.2011.6. Epub 2011 Feb 9.
PubMed 21307846Elms L, Shannon S, Hughes S, Lewis N. Cannabidiol in the Treatment of Post-Traumatic Stress Disorder: A Case Series. J Altern Complement Med. 2019 Apr;25(4):392-397. doi: 10.1089/acm.2018.0437. Epub 2018 Dec 13.
PubMed 30543451Masataka N. Anxiolytic Effects of Repeated Cannabidiol Treatment in Teenagers With Social Anxiety Disorders. Front Psychol. 2019 Nov 8;10:2466. doi: 10.3389/fpsyg.2019.02466. eCollection 2019.
PubMed 31787910Linares IM, Zuardi AW, Pereira LC, Queiroz RH, Mechoulam R, Guimaraes FS, Crippa JA. Cannabidiol presents an inverted U-shaped dose-response curve in a simulated public speaking test. Braz J Psychiatry. 2019 Jan-Feb;41(1):9-14. doi: 10.1590/1516-4446-2017-0015. Epub 2018 Oct 11.
PubMed 30328956Gallily 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
Russo EB. Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects. Br J Pharmacol. 2011 Aug;163(7):1344-64. doi: 10.1111/j.1476-5381.2011.01238.x.
PubMed 21749363
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of CBD Oil for Reducing the Negative Emotional Impact of COVID-19: A Randomized Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04603781
- Acronym / sponsor ID
- CBDOIL / 2020-07-0138
- Conditions
- Anxiety Depression, Alcohol Abuse, Substance Abuse, Anger, Sleep Disturbance, Stress Reaction
- Keywords
- CBD Oil, CBD Isolate, COVID-19, stress symptoms, RCT
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason 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.)
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Way West Wellness, SunFlora.Inc
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Significance of the Proposed Project
The COVID-19 pandemic has hit us like a ton of bricks creating unimaginable levels of unanticipated death, financial hardship, and dramatic changes in nearly every facet of our life including school, work, shopping, social and family life. Sadly, the physical, mental, economic, and health burden of COVID-19 disproportionately affects the poor, the elderly, and people of color.
The stress induced by these changes as well as the lack of control we have over them increases risk for new onset of mental health problems such as anxiety, depression, substance abuse, sleep disturbance, and family violence as well as exacerbation of symptoms among those with pre-existing psychiatric conditions. Although many people will successfully manage the increased stress from COVID-19 on their own or with the support from family and friends, others may need extra help to cope. Consequently, there is an urgent need for developing cost-effective strategies for managing the stress-induced psychological consequences of COVID-19.
There's been considerable excitement in the press over the potential therapeutic use of cannabidiol (CBD) products in the treatment of a variety of physical and mental health problems. Delta-9-tetrahydrocannabinol (delta-9 THC) is still illegal in most states because of its psychoactive abuse potential. In contrast, cannabidiol (CBD) does not convert to THC in the body and has negligible side effects relative to main-stream psychiatric drugs (benzodiazepines and antidepressants) commonly prescribed for the treatment of stress-related disorders such as anxiety, depression, and insomnia. Mounting evidence from studies with rodents suggests that CBD may confer significant promising health-related benefits including anti-inflammatory, pain-relieving, anti-cancer, memory enhancement, and facilitation of fear extinction (see White for a recent review).
The biggest success story for CBD use in humans to date comes from placebo-controlled randomized clinical trials demonstrating a 50% or more reduction in previously intractable seizures in children suffering from Dravet syndrome and Lennox-Gastaut syndrome. Moreover, several controlled clinical trials have shown promising findings in reducing psychotic symptoms among patients with schizophrenia and among young adults displaying THC-induced psychosis.
Preliminary Evidence that CBD may offer promise in the treatment of stress-related disorders has started to emerge. A small pilot trial with 24 patients presenting with social anxiety disorder found that relative to placebo, a single dose of 100 mg of CBD oil led to lower levels of anxiety, cognitive impairment, and discomfort in their actual speech performance as well as their anxiety before the speech. An uncontrolled case series of 11 PTSD patients receiving 8 weeks of CBD, reported a 28% reduction in PTSD symptom scores. In a small 4-week placebo-controlled study of 37 young Japanese adults with social anxiety disorder, Masataka found a significant advantage of CBD over placebo in reducing subjects' scores on two widely used measures of social anxiety symptoms.
Why Compare CBD-Isolate with Broad-Spectrum and Full-Spectrum CBD? CBD isolate is the purest form of CBD. It is made by extracting it from its natural environment - either hemp which is legal and recognized as generally safe in all states because of its low THC content (less than .3%), or the marijuana plant which has high levels of THC (up to 30%) and remains a Schedule 1 controlled substance under the Controlled Substances Act of 1970.
Unlike hemp-derived CBD Isolate, hemp-derived full-spectrum CBD contains all the hundreds of phytochemicals naturally found in the cannabis plant, including CBD, trace cannabinoids including Cannabinol (CBN), Cannabichromene (CBC), Cannabigerol (CBDA) and Cannabidivarin (CBDV), and more than 200 different terpenes, essential oils, and negligible THC content (less than 0.3%).
Research demonstrating the wide-ranging therapeutic effects of CBD oil including anti-emetic, anti-inflammatory, anxiolytic, and anti-psychotic effects were based on studies using pure doses of CBD Isolate. However, more recently it has been shown that the therapeutic effects of purified CBD display a bell-shaped dose-response curve suggesting a limited dose range, with no beneficial effects achieved at either lower or higher doses. This narrow therapeutic window presents a challenge for using CBD isolate clinically.
Based on recent research with rodents and humans, administration of a full spectrum cannabis extract containing mostly CBD but also containing other minor phytocannabinoids and non-cannabinoids exerted a synergistic effect with CBD that was both more effective than CBD Isolate without the unwanted bell-shaped dose-response curve. This finding has been named the entourage effect. However, to date, there are no human trials for any physical or mental health problem comparing the gold standard CBD isolate with a full-spectrum CBD formulation, despite the fact that both forms of CBD are widely available without a prescription in stores all across the United States. The proposed project will provide important data to determine whether a full-spectrum CBD formulation offers any advantages over CBD isolate in reducing COVID-19 stress-induced symptoms.
Specific Aims and Hypotheses:
- Compare the efficacy of a 4-week daily regimen of hemp-derived CBD isolate (300 mg/day), broad-spectrum CBD oil, full spectrum CBD oil (300 mg/day), or placebo oil in reducing patient-rated symptoms of stress, anxiety, depression, and sleep disturbance. It is predicted that patients receiving and of the three active CBD oil formulations (pure isolate, broad-spectrum, or full spectrum CBD oil) will show significantly greater reduction in emotional distress and sleep disturbance relative to those receiving placebo oil. It is also predicted that broad-spectrum and full-spectrum CBD oil will outperform CBD isolate in reducing COVID-19 stress-induced symptoms of stress, anxiety, depression, anger, and sleep disturbance.
- Examine predictors of patients' clinical response to the 4 treatments. It is expected that the superiority of broad-spectrum and full-spectrum CBD oil relative to CBD isolate or placebo will be more pronounced for patients showing more severe COVID-19 stress-induced symptoms at baseline.
- Examine the perceived acceptability and side effects profile of 4 weeks of daily CBD/Placebo oil ingestion. It is expected that each of the three CBD formulations (CBD isolate, Broad-spectrum or Full spectrum CBD oil) will show minimal side effects that will not exceed the level of side effects for those ingesting placebo oil with the possible exception of somnolence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4-arm double-blind placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| CBD-Isolate 300 mg. | Active comparator | Dietary Supplement: CBD IsolateNightly oral administration of 300 mg. of CBD-Isolate for 28 consecutive days |
| Full-Spectrum CBD Oil 300 mg. | Active comparator | Dietary Supplement: Full Spectrum CBD OilNightly oral administration of 300 mg. of Full Spectrum CBD Oil for 28 consecutive days |
| Broad-Spectrum CBD oil 300 mg. | Active comparator | Dietary Supplement: Broad-Spectrum CBD OilNightly oral administration of 300 mg. of Broad-Spectrum CBD Oil for 28 consecutive days |
| Placebo Oil | Placebo comparator | Dietary Supplement: Placebo OilNightly oral administration of 300 mg. of Placebo Oil for 28 consecutive days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBD IsolateAlso: Pure CBD oil300 mg. daily dose of CBD Isolate Oil | Dietary supplement | CBD-Isolate 300 mg. |
| Full Spectrum CBD Oil300 mg. daily dose of CBD with full spectrum of other cannabinoids found in the hemp plant | Dietary supplement | Full-Spectrum CBD Oil 300 mg. |
| Broad-Spectrum CBD Oil300 mg. daily dose of CBD with a selected spectrum of other cannabinoids found in the hemp plant | Dietary supplement | Broad-Spectrum CBD oil 300 mg. |
| Placebo OilMCT Oil with mint flavoring | Dietary supplement | Placebo Oil |
Primary outcome
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.
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.
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.
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.
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.
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.
38 secondary outcomes
PROMIS Depression Scale
Time frame: Week 0-Baseline
PROMIS Depression Scale
Time frame: Week 1-Treatment
PROMIS Depression Scale
Time frame: Week 2-Treatment
PROMIS Depression Scale
Time frame: Week 3-Treatment
PROMIS Depression Scale
Time frame: Week 4-Treatment
PROMIS Depression Scale
Time frame: Week 5-Follow-up
PROMIS Anxiety Scale
Time frame: Week 0- Baseline
PROMIS Anxiety Scale
Time frame: Week 1-Treatment
PROMIS Anxiety Scale
Time frame: Week 2-Treatment
PROMIS Anxiety Scale
Time frame: Week 3-Treatment
PROMIS Anxiety Scale
Time frame: Week 4-Treatment
PROMIS Anxiety Scale
Time frame: Week 5-Follow-up
PROMIS Anger Scale
Time frame: Week 0- Baseline
PROMIS Anger Scale
Time frame: Week 1- Treatment
PROMIS Anger Scale
Time frame: Week 2- Treatment
PROMIS Anger Scale
Time frame: Week 3- Treatment
PROMIS Anger Scale
Time frame: Week 4- Treatment
PROMIS Anger Scale
Time frame: Week 5- Follow-up
PROMIS Alcohol Negative Consequences Scale
Time frame: Week 0- Baseline
PROMIS Alcohol Negative Consequences Scale
Time frame: Week 1- Treatment
PROMIS Alcohol Negative Consequences Scale
Time frame: Week 2- Treatment
PROMIS Alcohol Negative Consequences Scale
Time frame: Week 3- Treatment
PROMIS Alcohol Negative Consequences Scale
Time frame: Week 4- Treatment
PROMIS Alcohol Negative Consequences Scale
Time frame: Week 5- Follow-up
PROMIS Sleep Disturbance Scale
Time frame: Week 0- Baseline
PROMIS Sleep Disturbance Scale
Time frame: Week 1- Treatment
PROMIS Sleep Disturbance Scale
Time frame: Week 2- Treatment
PROMIS Sleep Disturbance Scale
Time frame: Week 3- Treatment
PROMIS Sleep Disturbance Scale
Time frame: Week 4- Treatment
PROMIS Sleep Disturbance Scale
Time frame: Week 5- Follow-up
COVID-19 Coping Self-Efficacy
Time frame: Week 0- Baseline
COVID-19 Coping Self-Efficacy
Time frame: Week 1- Treatment
COVID-19 Coping Self-Efficacy
Time frame: Week 2- Treatment
COVID-19 Coping Self-Efficacy
Time frame: Week 3- Treatment
COVID-19 Coping Self-Efficacy
Time frame: Week 4- Treatment
COVID-19 Coping Self-Efficacy
Time frame: Week 5- Follow-up
Sheehan Disability Scale
Time frame: Week 0- Baseline
Sheehan Disability Scale
Time frame: Week 5- Follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 32721026Cowger TL, Davis BA, Etkins OS, Makofane K, Lawrence JA, Bassett MT, Krieger N. Comparison of Weighted and Unweighted Population Data to Assess Inequities in Coronavirus Disease 2019 Deaths by Race/Ethnicity Reported by the US Centers for Disease Control and Prevention. JAMA Netw Open. 2020 Jul 1;3(7):e2016933. doi: 10.1001/jamanetworkopen.2020.16933.
- Background: PubMed 32370116Mazza C, Ricci E, Biondi S, Colasanti M, Ferracuti S, Napoli C, Roma P. A Nationwide Survey of Psychological Distress among Italian People during the COVID-19 Pandemic: Immediate Psychological Responses and Associated Factors. Int J Environ Res Public Health. 2020 May 2;17(9):3165. doi: 10.3390/ijerph17093165.
- Background: PubMed 30730563White CM. A Review of Human Studies Assessing Cannabidiol's (CBD) Therapeutic Actions and Potential. J Clin Pharmacol. 2019 Jul;59(7):923-934. doi: 10.1002/jcph.1387. Epub 2019 Feb 7.
- Background: PubMed 28538134Devinsky O, Cross JH, Laux L, Marsh E, Miller I, Nabbout R, Scheffer IE, Thiele EA, Wright S; Cannabidiol in Dravet Syndrome Study Group. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome. N Engl J Med. 2017 May 25;376(21):2011-2020. doi: 10.1056/NEJMoa1611618.
- Background: PubMed 29768152Devinsky O, Patel AD, Cross JH, Villanueva V, Wirrell EC, Privitera M, Greenwood SM, Roberts C, Checketts D, VanLandingham KE, Zuberi SM; GWPCARE3 Study Group. Effect of Cannabidiol on Drop Seizures in the Lennox-Gastaut Syndrome. N Engl J Med. 2018 May 17;378(20):1888-1897. doi: 10.1056/NEJMoa1714631.
- Background: PubMed 29241357McGuire P, Robson P, Cubala WJ, Vasile D, Morrison PD, Barron R, Taylor A, Wright S. Cannabidiol (CBD) as an Adjunctive Therapy in Schizophrenia: A Multicenter Randomized Controlled Trial. Am J Psychiatry. 2018 Mar 1;175(3):225-231. doi: 10.1176/appi.ajp.2017.17030325. Epub 2017 Dec 15.
- Background: PubMed 16401651Zuardi AW, Hallak JE, Dursun SM, Morais SL, Sanches RF, Musty RE, Crippa JA. Cannabidiol monotherapy for treatment-resistant schizophrenia. J Psychopharmacol. 2006 Sep;20(5):683-6. doi: 10.1177/0269881106060967. Epub 2006 Jan 9.
- Background: PubMed 18378995Morgan CJ, Curran HV. Effects of cannabidiol on schizophrenia-like symptoms in people who use cannabis. Br J Psychiatry. 2008 Apr;192(4):306-7. doi: 10.1192/bjp.bp.107.046649.
- Background: PubMed 21307846Bergamaschi MM, Queiroz RH, Chagas MH, de Oliveira DC, De Martinis BS, Kapczinski F, Quevedo J, Roesler R, Schroder N, Nardi AE, Martin-Santos R, Hallak JE, Zuardi AW, Crippa JA. Cannabidiol reduces the anxiety induced by simulated public speaking in treatment-naive social phobia patients. Neuropsychopharmacology. 2011 May;36(6):1219-26. doi: 10.1038/npp.2011.6. Epub 2011 Feb 9.
- Background: PubMed 30543451Elms L, Shannon S, Hughes S, Lewis N. Cannabidiol in the Treatment of Post-Traumatic Stress Disorder: A Case Series. J Altern Complement Med. 2019 Apr;25(4):392-397. doi: 10.1089/acm.2018.0437. Epub 2018 Dec 13.
- Background: PubMed 31787910Masataka N. Anxiolytic Effects of Repeated Cannabidiol Treatment in Teenagers With Social Anxiety Disorders. Front Psychol. 2019 Nov 8;10:2466. doi: 10.3389/fpsyg.2019.02466. eCollection 2019.
- Background: PubMed 30328956Linares IM, Zuardi AW, Pereira LC, Queiroz RH, Mechoulam R, Guimaraes FS, Crippa JA. Cannabidiol presents an inverted U-shaped dose-response curve in a simulated public speaking test. Braz J Psychiatry. 2019 Jan-Feb;41(1):9-14. doi: 10.1590/1516-4446-2017-0015. Epub 2018 Oct 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Telch, Ph.D. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CBD Isolate, Full Spectrum CBD Oil and Broad-Spectrum CBD Oil in people with Anxiety Depression and Alcohol Abuse, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Emotional Distress Index (time frame: Week 0-Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04603781, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.