Outcomes Mandate National Integration With Cannabis as Medicine
Who is this study for? Child to adult patients with Chronic Pain
What treatments are being studied? Cannabis
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Healthy Volunteers: t
View:
• 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
Locations
United States
Florida
OMNI Medical Services
RECRUITING
Boca Raton
OMNI Medical Services
RECRUITING
Bradenton
OMNI Medical Services
RECRUITING
Fort Lauderdale
OMNI Medical Services
RECRUITING
Fort Myers
OMNI Medical Services
RECRUITING
Gainesville
OMNI Medical Services
RECRUITING
Merritt Island
OMNI Medical Services
RECRUITING
Miami
OMNI Medical Services
RECRUITING
Ocoee
OMNI Medical Services
RECRUITING
Pensacola
OMNI Medical Services
RECRUITING
Pompano Beach
OMNI Medical Services
RECRUITING
Tampa
OMNI Medical Services
RECRUITING
Wesley Chapel
Ohio
OMNI Medical Services
RECRUITING
Beechwood
OMNI Medical Services
RECRUITING
Bowling Green
OMNI Medical Services
RECRUITING
Sandusky
OMNI Medical Services
RECRUITING
Toledo
OMNI Medical Services
RECRUITING
Toledo
Contact Information
Primary
Dr. Ryan O Lakin, MD JD
ryan.lakin.md@gmail.com
419-214-3220
Time Frame
Start Date: 2018-12-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 200000
Treatments
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.
Authors
Related Therapeutic Areas
Sponsors
Leads: OMNI Medical Services, LLC
Collaborators: OMNI Medical Services Inc