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NCT03944447 | RECRUITING | Chronic Pain


Outcomes Mandate National Integration With Cannabis as Medicine
Sponsor:

OMNI Medical Services, LLC

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.

Condition or disease

Chronic Pain

Chronic Pain Syndrome

Chronic Pain Due to Injury

Chronic Pain Due to Trauma

Fibromyalgia

Seizures

Hepatitis 100

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

Intervention/treatment

Cannabis, Medical

RYAH-Medtech Inhaler

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200000 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Outcomes Mandate National Integration With Cannabis as Medicine
Actual Study Start Date : 2018-12-01
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 7 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

Outcomes Mandate National Integration With Cannabis as Medicine

Location Details

NCT03944447


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, Florida

OMNI Medical Services

Boca Raton, Florida, United States, 33433

RECRUITING

United States, Florida

OMNI Medical Services

Bradenton, Florida, United States, 34209

RECRUITING

United States, Florida

OMNI Medical Services

Fort Lauderdale, Florida, United States, 33308

RECRUITING

United States, Florida

OMNI Medical Services

Fort Myers, Florida, United States, 34135

RECRUITING

United States, Florida

OMNI Medical Services

Gainesville, Florida, United States, 36201

RECRUITING

United States, Florida

OMNI Medical Services

Merritt Island, Florida, United States, 32952

RECRUITING

United States, Florida

OMNI Medical Services

Miami, Florida, United States, 33137

RECRUITING

United States, Florida

OMNI Medical Services

Ocoee, Florida, United States, 34761

RECRUITING

United States, Florida

OMNI Medical Services

Pensacola, Florida, United States, 32505

RECRUITING

United States, Florida

OMNI Medical Services

Pompano Beach, Florida, United States, 33060

RECRUITING

United States, Florida

OMNI Medical Services

Tampa, Florida, United States, 33614

RECRUITING

United States, Florida

OMNI Medical Services

Wesley Chapel, Florida, United States, 33544

RECRUITING

United States, Ohio

OMNI Medical Services

Beechwood, Ohio, United States, 44122

RECRUITING

United States, Ohio

OMNI Medical Services

Bowling Green, Ohio, United States, 43402

RECRUITING

United States, Ohio

OMNI Medical Services

Sandusky, Ohio, United States, 44870

RECRUITING

United States, Ohio

OMNI Medical Services

Toledo, Ohio, United States, 43604

RECRUITING

United States, Ohio

OMNI Medical Services

Toledo, Ohio, United States, 43611

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