Outcomes Mandate National Integration With Cannabis as Medicine

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.

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

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.

Sponsors & Collaborators

• OMNI Medical Services Inc

  collaborator UNKNOWN

• OMNI Medical Services, LLC

  lead NETWORK

Principal Investigators

• Dr. Ryan O Lakin, MD JD · OMNI Medical Services Inc

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-12-01

Primary Completion

2025-12-31

Completion

2025-12-31

FDA Drug

Yes

Countries

• United States

Study Locations