Outcomes Mandate National Integration With Cannabis as Medicine

Last updated: May 29, 2022
Sponsor: OMNI Medical Services, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Coronavirus

Cancer

Bipolar Disorder

Treatment

N/A

Clinical Study ID

NCT03944447
Pro00033337
  • Ages > 7
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 guardianas defined under state law parameters
  • Must be willing to complete online surveys at baseline and the follow up points inthis study

Exclusion

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 ofcannabis

Study Design

Total Participants: 200000
Study Start date:
December 01, 2018
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • OMNI Medical Services

    Boca Raton, Florida 33433
    United States

    Active - Recruiting

  • OMNI Medical Services

    Bradenton, Florida 34209
    United States

    Active - Recruiting

  • OMNI Medical Services

    Fort Lauderdale, Florida 33308
    United States

    Active - Recruiting

  • OMNI Medical Services

    Fort Myers, Florida 34135
    United States

    Active - Recruiting

  • OMNI Medical Services

    Gainesville, Florida 36201
    United States

    Active - Recruiting

  • OMNI Medical Services

    Merritt Island, Florida 32952
    United States

    Active - Recruiting

  • OMNI Medical Services

    Miami, Florida 33137
    United States

    Active - Recruiting

  • OMNI Medical Services

    Ocoee, Florida 34761
    United States

    Active - Recruiting

  • OMNI Medical Services

    Pensacola, Florida 32505
    United States

    Active - Recruiting

  • OMNI Medical Services

    Pompano Beach, Florida 33060
    United States

    Active - Recruiting

  • OMNI Medical Services

    Tampa, Florida 33614
    United States

    Active - Recruiting

  • OMNI Medical Services

    Wesley Chapel, Florida 33544
    United States

    Active - Recruiting

  • OMNI Medical Services

    Beechwood, Ohio 44122
    United States

    Active - Recruiting

  • OMNI Medical Services

    Bowling Green, Ohio 43402
    United States

    Active - Recruiting

  • OMNI Medical Services

    Sandusky, Ohio 44870
    United States

    Active - Recruiting

  • OMNI Medical Services

    Toledo, Ohio 43604
    United States

    Active - Recruiting

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