Outcomes Mandate National Integration With Cannabis as Medicine

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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