Brief Title
Outcomes Mandate National Integration With Cannabis as Medicine
Official Title
Outcomes Mandate National Integration With Cannabis as Medicine
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Prevention of COVID-19
Secondary Outcome
Cannabis Impact on Quality of Life
Condition
Chronic Pain
Intervention
Cannabis, Medical
Study Arms / Comparison Groups
Cannabis users
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
200000
Start Date
December 1, 2018
Completion Date
December 31, 2025
Primary Completion Date
December 31, 2025
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
Gender
All
Ages
7 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Dr. Ryan O Lakin, MD JD, 419-214-3220, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03944447
Organization ID
Pro00033337
Responsible Party
Sponsor
Study Sponsor
OMNI Medical Services, LLC
Collaborators
OMNI Medical Services Inc
Study Sponsor
Dr. Ryan O Lakin, MD JD, Principal Investigator, OMNI Medical Services Inc
Verification Date
February 2022