Outcomes Mandate National Integration With Cannabis as Medicine

NCT03944447 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: Pro00033337
• Study Type: interventional
• Target: 200,000
• Locations: 1 country
• Sites: 17

Brief 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; COVID-19; SARS-CoV Infection; Corona Virus Infection; Coronavirus

Outcome Measures

Primary Outcomes (3)

• Prevention of COVID-19

  Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).

  Five years

• Treatment of COVID-19

  Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).

  Five years

• Treatment of Symptoms

  The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.

  Five years

Secondary Outcomes (3)

• Cannabis Impact on Quality of Life

  Five years

• Cannabis Route and Dosing

  Five years

• Monitoring Adverse Events

  Five years

Study Arms (4)

Cannabis users

EXPERIMENTAL

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.

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

Cancer prevention

EXPERIMENTAL

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.

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

Life-Threatening Conditions

EXPERIMENTAL

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.

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

COVID-19 / SARS-CoV-2

EXPERIMENTAL

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.

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

Interventions

Cannabis, Medical DRUG

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.

Also known as: Marijuana Medical, Marijuana Treatment

COVID-19 / SARS-CoV-2; Cancer prevention; Cannabis users; Life-Threatening Conditions

RYAH-Medtech Inhaler DEVICE

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.

COVID-19 / SARS-CoV-2; Cancer prevention; Cannabis users; Life-Threatening Conditions

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OMNI Medical Services, LLC: lead
• OMNI Medical Services Inc: collaborator

Study Sites (17)

OMNI Medical Services

Boca Raton, Florida, 33433, United States

RECRUITING

OMNI Medical Services

Bradenton, Florida, 34209, United States

RECRUITING

OMNI Medical Services

Fort Lauderdale, Florida, 33308, United States

RECRUITING

OMNI Medical Services

Fort Myers, Florida, 34135, United States

RECRUITING

OMNI Medical Services

Gainesville, Florida, 36201, United States

RECRUITING

OMNI Medical Services

Merritt Island, Florida, 32952, United States

RECRUITING

OMNI Medical Services

Miami, Florida, 33137, United States

RECRUITING

OMNI Medical Services

Ocoee, Florida, 34761, United States

RECRUITING

OMNI Medical Services

Pensacola, Florida, 32505, United States

RECRUITING

OMNI Medical Services

Pompano Beach, Florida, 33060, United States

RECRUITING

OMNI Medical Services

Tampa, Florida, 33614, United States

RECRUITING

OMNI Medical Services

Wesley Chapel, Florida, 33544, United States

RECRUITING

OMNI Medical Services

Beechwood, Ohio, 44122, United States

RECRUITING

OMNI Medical Services

Bowling Green, Ohio, 43402, United States

RECRUITING

OMNI Medical Services

Sandusky, Ohio, 44870, United States

RECRUITING

OMNI Medical Services

Toledo, Ohio, 43604, United States

RECRUITING

OMNI Medical Services

Toledo, Ohio, 43611, United States

RECRUITING

Related Links

• OMNI Medical Services Website

MeSH Terms

Conditions

Chronic Pain; Fibromyalgia; Seizures; Hepatitis C; Neoplasms; Crohn Disease; Acquired Immunodeficiency Syndrome; Multiple Sclerosis; Brain Injuries, Traumatic; Anemia, Sickle Cell; Stress Disorders, Post-Traumatic; Tourette Syndrome; Colitis, Ulcerative; Glaucoma; Epilepsy; Inflammatory Bowel Diseases; Parkinson Disease; Amyotrophic Lateral Sclerosis; Chronic Traumatic Encephalopathy; Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders; Autistic Disorder; Opioid-Related Disorders; Bipolar Disorder; COVID-19; Severe Acute Respiratory Syndrome; Coronavirus Infections

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Basal Ganglia Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Neurodevelopmental Disorders; Colitis; Colonic Diseases; Ocular Hypertension; Eye Diseases; Parkinsonian Disorders; Synucleinopathies; Spinal Cord Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Brain Injury, Chronic; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Bipolar and Related Disorders; Mood Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronaviridae Infections; Nidovirales Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Dr. Ryan O Lakin, MD JD

  OMNI Medical Services Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Ryan O Lakin, MD JD

CONTACT

419-214-3220; ryan.lakin.md@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 9, 2019
• Study Start: December 1, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)