Outcomes Mandate National Integration With Cannabis as Medicine

Study Purpose:

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.

Study Status:

Recruiting

Disease:

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

Study Type:

Interventional

Type of Intervention:

Drug, Device

Intervention Name:

Cannabis, Medical, RYAH-Medtech Inhaler

Placebo:

Phase:

Phase 2

Study Chair(s)/Principal Investigator(s):

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

Clinicaltrials.gov ID:

NCT03944447

Neals Affiliated?

Coordinating Center Contact Information

Dr. Ryan O Lakin, MD JD / email hidden; JavaScript is required / 419-214-3220

Full Study Summary:

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 Sponsor:

OMNI Medical Services, LLC

Estimated Enrollment:

200000

Estimated Study Start Date:

12 / 01 / 2018

Estimated Study Completion Date:

12 / 31 / 2025

Posting Last Modified Date:

06 / 02 / 2022

Date Study Added to neals.org:

05 / 09 / 2019

Minimum Age:

7 Years

Maximum Age:

N/A

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