Outcomes Mandate National Integration With Cannabis as Medicine

Depression Clinical Trial

— OMNI-Can  

Official title:

Outcomes Mandate National Integration With Cannabis as Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03944447
• Other study ID #: Pro00033337
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2022
• Source: OMNI Medical Services, LLC
• Contact: Dr. Ryan O Lakin, MD JD
• Phone: 419-214-3220
• Email: ryan.lakin.md[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Anemia, Sickle Cell
• Anxiety
• Autism
• Bipolar Disorder
• Brain Diseases
• Brain Injuries
• Brain Injuries, Traumatic
• Cancer
• Chronic Pain
• Chronic Pain Due to Injury
• Chronic Pain Due to Trauma
• Chronic Pain Syndrome
• Chronic Traumatic Encephalopathy
• Communicable Diseases
• Corona Virus Infection
• Coronavirus
• Coronavirus Infections
• COVID-19
• Covid19
• Crohn Disease
• Depression
• Disease
• Epilepsy
• Fibromyalgia
• Glaucoma
• Hepatitis C
• HIV/AIDS
• Infections
• Inflammatory Bowel Diseases
• Insomnia
• Motor Neuron Disease
• Multiple Sclerosis
• Opioid-Related Disorders
• Opioid-use Disorder
• Parkinson Disease
• Post Traumatic Stress Disorder
• SARS-CoV Infection
• Sclerosis
• Seizures
• Sickle Cell Disease
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Syndrome
• Tourette Syndrome
• Traumatic Brain Injury
• Ulcerative Colitis
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	OMNI Medical Services	Beechwood	Ohio
United States	OMNI Medical Services	Boca Raton	Florida
United States	OMNI Medical Services	Bowling Green	Ohio
United States	OMNI Medical Services	Bradenton	Florida
United States	OMNI Medical Services	Fort Lauderdale	Florida
United States	OMNI Medical Services	Fort Myers	Florida
United States	OMNI Medical Services	Gainesville	Florida
United States	OMNI Medical Services	Merritt Island	Florida
United States	OMNI Medical Services	Miami	Florida
United States	OMNI Medical Services	Ocoee	Florida
United States	OMNI Medical Services	Pensacola	Florida
United States	OMNI Medical Services	Pompano Beach	Florida
United States	OMNI Medical Services	Sandusky	Ohio
United States	OMNI Medical Services	Tampa	Florida
United States	OMNI Medical Services	Toledo	Ohio
United States	OMNI Medical Services	Toledo	Ohio
United States	OMNI Medical Services	Wesley Chapel	Florida

Sponsors (2)

Lead Sponsor	Collaborator
OMNI Medical Services, LLC	OMNI Medical Services Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Cannabis Impact on Quality of Life	Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.	Five years
Secondary	Cannabis Route and Dosing	Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.	Five years
Secondary	Monitoring Adverse Events	Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.	Five years

External Links

•   OMNI Medical Services Website