NCT03944447

Outcomes Mandate National Integration With Cannabis as Medicine

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200,000 (estimated)
• Sponsor: OMNI Medical Services, LLC · Network
• Sex: All
• Age: 7 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Cannabis, Medical	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.
DEVICE	RYAH-Medtech Inhaler	Our research study will involve incorporation of RYAH-Medtech company's devices into our protocols. They have an inhaler and a transdermal patch for both hemp-derived CBD and cannabis. RYAH has developed an integrated phone app for tracking product use and patient response. They are currently involved in clinical trials in Europe. OMNI Medical will integrate the partner with RYAH device for several reasons. Primary goals will involve using their integrated smart phone app to collect and secure large quantities of data. Secondary goals will include FDA approval as a medical device. The specific cannabis strain will be tracked using scannable QR codes programed into the smart phone app. This will allow us to track patient feedback and capture data on usage. OMNI Medical will have patients use RYAH's products as part of and FDA Investigational Device Exemption, which requires an IRB. Use of the devices would be completely voluntary by study participants.

Timeline

• Start date: 2018-12-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2019-05-09
• Last updated: 2022-06-02

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study