Condition or disease | Intervention/treatment | Phase |
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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 | Drug: Cannabis, Medical | Phase 2 |
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 (Clinical Trial) |
Estimated Enrollment : | 200000 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19 |
Actual Study Start Date : | December 1, 2018 |
Estimated Primary Completion Date : | December 31, 2025 |
Estimated Study Completion Date : | December 31, 2025 |
Arm | Intervention/treatment |
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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.
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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.
Other Names:
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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.
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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.
Other Names:
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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. |
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.
Other Names:
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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.
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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.
Other Names:
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Ages Eligible for Study: | 7 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dr. Ryan O Lakin, MD JD | 419-214-3220 | ryan.lakin.md@gmail.com |
United States, Florida | |
OMNI Medical Services | Recruiting |
Boca Raton, Florida, United States, 33433 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
OMNI Medical Services | Recruiting |
Bradenton, Florida, United States, 34209 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
OMNI Medical Services | Recruiting |
Fort Lauderdale, Florida, United States, 33308 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
OMNI Medical Services | Recruiting |
Fort Myers, Florida, United States, 34135 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
OMNI Medical Services | Recruiting |
Gainesville, Florida, United States, 36201 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
OMNI Medical Services | Recruiting |
Merritt Island, Florida, United States, 32952 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
OMNI Medical Services | Recruiting |
Miami, Florida, United States, 33137 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
OMNI Medical Services | Recruiting |
Ocoee, Florida, United States, 34761 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
OMNI Medical Services | Recruiting |
Pensacola, Florida, United States, 32505 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
OMNI Medical Services | Recruiting |
Pompano Beach, Florida, United States, 33060 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
OMNI Medical Services | Recruiting |
Tampa, Florida, United States, 33614 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
OMNI Medical Services | Recruiting |
Wesley Chapel, Florida, United States, 33544 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
United States, Ohio | |
OMNI Medical Services | Recruiting |
Beechwood, Ohio, United States, 44122 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
OMNI Medical Services | Recruiting |
Bowling Green, Ohio, United States, 43402 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
OMNI Medical Services | Recruiting |
Sandusky, Ohio, United States, 44870 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 | |
OMNI Medical Services | Recruiting |
Toledo, Ohio, United States, 43604 | |
Contact: Ryan O Lakin, MD JD 419-214-3220 | |
OMNI Medical Services | Recruiting |
Toledo, Ohio, United States, 43611 | |
Contact: Ryan O Lakin, MD JD 888-470-0008 |
Principal Investigator: | Dr. Ryan O Lakin, MD JD | OMNI Medical Services Inc |
Tracking Information | |||||
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First Submitted Date ICMJE | May 3, 2019 | ||||
First Posted Date ICMJE | May 9, 2019 | ||||
Last Update Posted Date | December 9, 2020 | ||||
Actual Study Start Date ICMJE | December 1, 2018 | ||||
Estimated Primary Completion Date | December 31, 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19 | ||||
Official Title ICMJE | Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19 | ||||
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | 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.
Other Names:
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
200000 | ||||
Original Estimated Enrollment ICMJE |
10000 | ||||
Estimated Study Completion Date ICMJE | December 31, 2025 | ||||
Estimated Primary Completion Date | December 31, 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 7 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03944447 | ||||
Other Study ID Numbers ICMJE | Pro00033337 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | OMNI Medical Services, LLC | ||||
Study Sponsor ICMJE | OMNI Medical Services, LLC | ||||
Collaborators ICMJE | OMNI Medical Services Inc | ||||
Investigators ICMJE |
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PRS Account | OMNI Medical Services, LLC | ||||
Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |