Outcomes Mandate National Integration With Cannabis as Medicine (OMNI-Can)

OMNI Medical Services

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: Cannabis, Medical; Device: RYAH-Medtech Inhaler

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT03944447

Pro00033337

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200,000 estimated patients

Sex: All

Ages: 7+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200,000 participants in 4 patient groups

Cannabis users

Experimental group

Description:

Most patients will have used cannabis before their initial physician visit, and many current patients will be returning for an in-person follow-up. Patients will be given the survey shortly after the physician encounter to assess baseline parameters with current cannabis use. Any patient who is "cannabis-naïve", defined as no use within the past year or longer, will be placed into a separate data analysis arm. The investigators will follow up with patients again at 3, 6, 9, and 12 months with the online survey. Patients returning for their annual physician encounter will continue on the 3-month survey schedule until the end of the study, or if lost to follow-up. There may be slight variations in the interval based on state law, for example in Florida the in-person follow-up with the physician is required every 210 days, and some states allow for 2 year in-person visits. Every attempt will be made to adhere to a 3-month interval survey distribution.

Treatment:

Drug: Cannabis, Medical

Device: RYAH-Medtech Inhaler

Cancer prevention

Experimental group

Description:

Non-cancer patient medical cannabis users with extensive or life-long cannabis use will be compared to the general population for incidence and prevalence of development of cancer. The hypothesis is that cannabis use acts as a cancer preventive substance.

Treatment:

Drug: Cannabis, Medical

Device: RYAH-Medtech Inhaler

Life-Threatening Conditions

Experimental group

Description:

Opioids are a class of drugs naturally found in the opium poppy plant. Opioids are often used as medicines because they contain chemicals that relax the body and can relieve pain. Prescription opioids are used mostly to treat moderate to severe pain. Opioids can also make people feel very relaxed and "high" - which is why they are sometimes used for non-medical reasons. This can be dangerous because opioids can be highly addictive, and overdoses and death are common. From 1999 to 2017, more than 700,000 people have died from a drug overdose. Around 68% of the more than 70,200 drug overdose deaths in 2017 involved an opioid. In 2017, the number of overdose deaths involving opioids was 6 times higher than in 1999. On average, 130 Americans die every day from an opioid overdose. This study will focus on examining outcomes of patients that have been treated with cannabis as a replacement or alternative to life-threatening opioids or other prescription drugs.

Treatment:

Drug: Cannabis, Medical

Device: RYAH-Medtech Inhaler

COVID-19 / SARS-CoV-2

Experimental group

Description:

Inhibition of viral entry and thereby spread constitute plausible therapeutic avenues. Similar to other respiratory pathogens, SARS-CoV2 is transmitted through respiratory droplets, with potential for aerosol and contact spread. It uses receptor-mediated entry into the human host via angiotensin-converting enzyme II (ACE2) that is expressed in lung tissue, as well as oral and nasal mucosa. Modulation of ACE2 levels in these gateway tissues may prove a plausible strategy for decreasing disease susceptibility. Cannabis sativa, especially one high in the anti-inflammatory cannabinoid cannabidiol (CBD), has been proposed to modulate gene expression and inflammation and possess anti-cancer and anti-inflammatory properties. Covid-19 infection rates in cannabis users will be compared to rates in the general population. Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population.

Treatment:

Drug: Cannabis, Medical

Device: RYAH-Medtech Inhaler