Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    200000
  • sponsor
    OMNI Medical Services, LLC
Updated on 27 January 2021
covid-19
brimonidine tartrate ophthalmic solution
disease or disorder
medical marijuana

Summary

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

Description

Medical cannabis has been legal in parts of the USA since 1996, with the stated intention of reducing pain (both acute and chronic) as well as for treatment of multiple other conditions. The original implementation of medical cannabis in the USA was implemented in California as a compassionate measure to treat the HIV/AIDS epidemic. Additional studies have shown promising outcome for patients with multiple sclerosis, seizures, cancer, and other chronic conditions. However, there have been few comprehensive studies that have actually measured whether cannabis is an effective treatment for pain reduction. There is an absence of multistate, multicenter clinical studies with cannabis as medicine, not only in the USA but globally. With the expansion of medical cannabis into more than 38 states in the US, this type of clinical study is now feasible.

On March 11, 2020, the World Health Organization formally characterized coronavirus, COVID-19, as a global pandemic and health systems globally are continuing their efforts to manage the outbreak. Coronavirus disease COVID-19 is an infectious disease caused by a newly discovered coronavirus. With the rapidly growing pandemic of COVID-19 caused by the new and challenging to treat zoonotic SARS-CoV2 coronavirus, there is an urgent need for new therapies and prevention strategies that can help curtail disease spread and reduce mortality. Inhibition of viral entry and thereby spread constitute plausible therapeutic avenues.

This study will utilize an anonymous novel online questionnaire to determine study participants' qualifying condition(s) for medical cannabis use, cannabis ingestion method, frequency of use, prescription drug use, and demographic information. Secondary factors will include evaluation of pain control, quality of life metrics, any adverse side effects from cannabis use, as well as changes in adjunctive treatments. Patients will be given medical cannabis recommendations and certifications commensurate with the state law in which the encounter occurs. The variations in mechanisms between the states for recommending, registering, certifying, and developing mandated treatment plans or doses will be adhered to; however, variations in state law and cannabis programs should not cause variation in the study design because the end-result is still the same with patients being treated with medical cannabis.

Details
Condition Fibromyalgia, Coronavirus Infection, Tourette's Disorder, Seizure, Gastroenteritis, Intestinal Diseases, Tic, Multiple Sclerosis, Myelopathy, Brain Injury, Amyotrophic Lateral Sclerosis, Cancer, Endogenous depression, Depression, Autism, Epilepsy, Insomnia, Bipolar Disorder, Ocular Hypertension, Glaucoma, chronic brain injury, Hepatitis C, Hepatitis C virus, Ulcerative Colitis, Post-Traumatic Stress Disorder, Inflammatory bowel disease, Pain, Crohn's Disease, SICKLE CELL ANEMIA, Severe Acute Respiratory Syndrome, Coronavirus, ANXIETY NEUROSIS, Anxiety, Myofascial Pain Syndrome, Parkinson's disease, Depression (Major/Severe), Chronic Pain, Opioid Use Disorder, Anxiety Disorders (Pediatric), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Post-Traumatic Stress Disorders, Depression (Treatment-Resistant), Generalized Anxiety Disorder (GAD), Cancer/Tumors, Amyotrophic Lateral Sclerosis (ALS), Post-Surgical Pain, Ewing's Family Tumors, Depressed, Generalized Anxiety Disorder (GAD - Pediatric), Chronic Pain Due to Injury, Chronic Pain Syndrome, Pain (Pediatric), Seizure Disorders (Pediatric), Cancer (Pediatric), Crohn's Disease (Pediatric), Ulcerative Colitis (Pediatric), Bipolar Disorders (Pediatric), Corona Virus Infection, Anxiety Symptoms, Radiologically Isolated Syndrome, Chronic Pain Due to Trauma, Autism Spectrum Disorder (ASD), Dermatite Atopique modérée ou grave, Neurology-Tic disorders, fibro, Anxiety Disorders, Manic Disorders, Seizure Disorders, Tourette's Syndrome, Traumatic Brain Injury, Spinal Cord Disorders, Neoplasms, Sickle Cell Disease, Bowel Dysfunction, Tic Disorders, HIV/AIDS, HIV/AIDS, HIV/AIDS, HIV/AIDS, Autism Spectrum Disorder, Brain Injuries, Traumatic, *COVID-19, Covid-19, COVID19, HIV/AIDS, HIV/AIDS, HIV/AIDS, HIV/AIDS, HIV/AIDS, depressive disorder, primary cancer, primary malignant neoplasm, PTSD, seizures, fits, fitting, convulsions, malignancy, cancers, malignancies, malignant tumor, malignant tumors, multiple sclerosis (ms), parkinson's, parkinson disease, inflammatory bowel diseases, chronic traumatic encephalopathy, crohns disease, traumatic brain injury (tbi), anxiety disorder, depressed mood, miserable, chronic pain syndromes, autistic, depressive disorders, anxious, epileptic, seizure disorder, epilepsia, epileptics, tourette syndrome, chronic pains, lou gehrig's disease, HIV/AIDS, HIV/AIDS, HIV/AIDS
Treatment Cannabis, Medical
Clinical Study IdentifierNCT03944447
SponsorOMNI Medical Services, LLC
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinical diagnosis of a Qualifying Condition for Medical Marijuana
Must be 18 years or older unless they have consent from their parent or legal guardian as defined under state law parameters
Must be willing to complete online surveys at baseline and the follow up points in this study

Exclusion Criteria

Pregnancy
Breastfeeding
Inability to provide informed consent
Inability to complete study visits or questionnaires
Active suicidality or psychosis, that could be exacerbated by the administration of cannabis
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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