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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 7 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03944447
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

OMNI Medical Services, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Dr. Ryan O Lakin, MD JD
Principal Investigator Affiliation OMNI Medical Services Inc
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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 Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: Cannabis users

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.

Experimental: Cancer prevention

Non-cancer patient medical cannabis users with extensive or life-long cannabis use will be compared to the general population for incidence and prevalence of development of cancer. The hypothesis is that cannabis use acts as a cancer preventive substance.

Experimental: Life-Threatening Conditions

Opioids are a class of drugs naturally found in the opium poppy plant. Opioids are often used as medicines because they contain chemicals that relax the body and can relieve pain. Prescription opioids are used mostly to treat moderate to severe pain. Opioids can also make people feel very relaxed and "high" - which is why they are sometimes used for non-medical reasons. This can be dangerous because opioids can be highly addictive, and overdoses and death are common. From 1999 to 2017, more than 700,000 people have died from a drug overdose. Around 68% of the more than 70,200 drug overdose deaths in 2017 involved an opioid. In 2017, the number of overdose deaths involving opioids was 6 times higher than in 1999. On average, 130 Americans die every day from an opioid overdose. This study will focus on examining outcomes of patients that have been treated with cannabis as a replacement or alternative to life-threatening opioids or other prescription drugs.

Experimental: COVID-19 / SARS-CoV-2

Inhibition of viral entry and thereby spread constitute plausible therapeutic avenues. Similar to other respiratory pathogens, SARS-CoV2 is transmitted through respiratory droplets, with potential for aerosol and contact spread. It uses receptor-mediated entry into the human host via angiotensin-converting enzyme II (ACE2) that is expressed in lung tissue, as well as oral and nasal mucosa. Modulation of ACE2 levels in these gateway tissues may prove a plausible strategy for decreasing disease susceptibility. Cannabis sativa, especially one high in the anti-inflammatory cannabinoid cannabidiol (CBD), has been proposed to modulate gene expression and inflammation and possess anti-cancer and anti-inflammatory properties. Covid-19 infection rates in cannabis users will be compared to rates in the general population. Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population.

Interventions

Drug: - Cannabis, Medical

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.

Device: - RYAH-Medtech Inhaler

Our research study will involve incorporation of RYAH-Medtech company's devices into our protocols. They have an inhaler and a transdermal patch for both hemp-derived CBD and cannabis. RYAH has developed an integrated phone app for tracking product use and patient response. They are currently involved in clinical trials in Europe. OMNI Medical will integrate the partner with RYAH device for several reasons. Primary goals will involve using their integrated smart phone app to collect and secure large quantities of data. Secondary goals will include FDA approval as a medical device. The specific cannabis strain will be tracked using scannable QR codes programed into the smart phone app. This will allow us to track patient feedback and capture data on usage. OMNI Medical will have patients use RYAH's products as part of and FDA Investigational Device Exemption, which requires an IRB. Use of the devices would be completely voluntary by study participants.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

OMNI Medical Services, Boca Raton, Florida

Status

Recruiting

Address

OMNI Medical Services

Boca Raton, Florida, 33433

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Bradenton, Florida

Status

Recruiting

Address

OMNI Medical Services

Bradenton, Florida, 34209

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Fort Lauderdale, Florida

Status

Recruiting

Address

OMNI Medical Services

Fort Lauderdale, Florida, 33308

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Fort Myers, Florida

Status

Recruiting

Address

OMNI Medical Services

Fort Myers, Florida, 34135

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Gainesville, Florida

Status

Recruiting

Address

OMNI Medical Services

Gainesville, Florida, 36201

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Merritt Island, Florida

Status

Recruiting

Address

OMNI Medical Services

Merritt Island, Florida, 32952

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Miami, Florida

Status

Recruiting

Address

OMNI Medical Services

Miami, Florida, 33137

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Ocoee, Florida

Status

Recruiting

Address

OMNI Medical Services

Ocoee, Florida, 34761

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Pensacola, Florida

Status

Recruiting

Address

OMNI Medical Services

Pensacola, Florida, 32505

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Pompano Beach, Florida

Status

Recruiting

Address

OMNI Medical Services

Pompano Beach, Florida, 33060

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Tampa, Florida

Status

Recruiting

Address

OMNI Medical Services

Tampa, Florida, 33614

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Wesley Chapel, Florida

Status

Recruiting

Address

OMNI Medical Services

Wesley Chapel, Florida, 33544

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Beechwood, Ohio

Status

Recruiting

Address

OMNI Medical Services

Beechwood, Ohio, 44122

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Bowling Green, Ohio

Status

Recruiting

Address

OMNI Medical Services

Bowling Green, Ohio, 43402

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Sandusky, Ohio

Status

Recruiting

Address

OMNI Medical Services

Sandusky, Ohio, 44870

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008

OMNI Medical Services, Toledo, Ohio

Status

Recruiting

Address

OMNI Medical Services

Toledo, Ohio, 43604

Site Contact

Ryan O Lakin, MD JD

[email protected]

419-214-3220

OMNI Medical Services, Toledo, Ohio

Status

Recruiting

Address

OMNI Medical Services

Toledo, Ohio, 43611

Site Contact

Ryan O Lakin, MD JD

[email protected]

888-470-0008