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Outcomes Mandate National Integration With Cannabis as Medicine

Outcomes Mandate National Integration With Cannabis as Medicine

Recruiting
7 years and older
All
Phase 2

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Overview

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.

Eligibility

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

Study details
    Chronic Pain
    Chronic Pain Syndrome
    Chronic Pain Due to Injury
    Chronic Pain Due to Trauma
    Fibromyalgia
    Seizures
    Hepatitis C
    Cancer
    Crohn Disease
    HIV/AIDS
    Multiple Sclerosis
    Traumatic Brain Injury
    Sickle Cell Disease
    Post Traumatic Stress Disorder
    Tourette Syndrome
    Ulcerative Colitis
    Glaucoma
    Epilepsy
    Inflammatory Bowel Diseases
    Parkinson Disease
    Amyotrophic Lateral Sclerosis
    Chronic Traumatic Encephalopathy
    Anxiety
    Depression
    Insomnia
    Autism
    Opioid-use Disorder
    Bipolar Disorder
    Covid19
    SARS-CoV Infection
    COVID-19
    Corona Virus Infection
    Coronavirus

NCT03944447

OMNI Medical Services, LLC

25 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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