Clinical trial NCT03944447: Outcomes Mandate National Integration With Cannabis as Medicine
Official title: Outcomes Mandate National Integration With Cannabis as Medicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
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
Lead sponsor: OMNI Medical Services, LLC
Sponsor class: NETWORK
Collaborators: name: OMNI Medical Services Inc
First posted: 2019-05-09
Enrollment: 200000
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevention of COVID-19
timeFrame: Five years
measure: Treatment of COVID-19
timeFrame: Five years
measure: Treatment of Symptoms
timeFrame: Five years
Secondary outcomes:
measure: Cannabis Impact on Quality of Life
timeFrame: Five years
measure: Cannabis Route and Dosing
timeFrame: Five years
measure: Monitoring Adverse Events
timeFrame: Five years
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: OMNI Medical Services
state: Florida
city: Bradenton
country: United States
facility: OMNI Medical Services
state: Florida
city: Fort Lauderdale
country: United States
facility: OMNI Medical Services
state: Florida
city: Fort Myers
country: United States
facility: OMNI Medical Services
state: Florida
city: Gainesville
country: United States
facility: OMNI Medical Services
state: Florida
city: Merritt Island
country: United States
facility: OMNI Medical Services
state: Florida
city: Miami
country: United States
facility: OMNI Medical Services
state: Florida
city: Ocoee
country: United States
facility: OMNI Medical Services
state: Florida
city: Pensacola
country: United States
facility: OMNI Medical Services
state: Florida
city: Pompano Beach
country: United States
facility: OMNI Medical Services
state: Florida
city: Tampa
country: United States
facility: OMNI Medical Services
state: Florida
city: Wesley Chapel
country: United States
facility: OMNI Medical Services
state: Florida
city: Beechwood
country: United States
facility: OMNI Medical Services
state: Ohio
city: Bowling Green
country: United States
facility: OMNI Medical Services
state: Ohio
city: Sandusky
country: United States
facility: OMNI Medical Services
state: Ohio
city: Toledo
country: United States
facility: OMNI Medical Services
state: Ohio
city: Toledo
country: United States
facility: OMNI Medical Services
state: Ohio
Study officials:
affiliation: OMNI Medical Services Inc
name: Dr. Ryan O Lakin, MD JD
role: PRINCIPAL_INVESTIGATOR
References: