SAN FRANCISCO, Nov. 3, 2021 /PRNewswire/ -- Curebase, a company committed to democratizing access to clinical studies, and LEVEL, a science-driven cannabis company on the cutting edge of cannabinoid research and innovation, today announced a decentralized clinical study to determine whether cannabis can have a positive impact on sleep quality for U.S. Veterans. LEVEL is pleased to co-sponsor this study with the Veterans Cannabis Group to identify and recruit participants for this research.
Military Veterans are four times more likely than members of the general public to have obstructive sleep apnea (OSA), according to the National Sleep Foundation. And a recent study showed that 92% of active-duty personnel with post-traumatic stress disorder (PTSD) reported clinically significant levels of insomnia, compared to 28% of those without PTSD.
"Sleep disruptions can affect everyone's health and overall quality of life, but the Veteran population in particular is vulnerable," said Curebase CEO Tom Lemberg. "The Curebase solution was designed for research trials to be able to measure a patients real life experience, in any location, including at home in their own bed. We are also uniquely supporting this population with our staff of virtual research coordinators, that will track participants progress, and proactively reach out with supportive conversations throughout the study. We're excited to partner with LEVEL in this decentralized clinical trial that may lead to genuine relief from sleep disorders for the brave people who have served our country."
The study will involve 109 Veteran volunteers and is scheduled to run for seven to eight weeks, with results to be released early next year. Participants in the decentralized clinical trial will be given measured doses of CBG, one of several rare cannabinoids in cannabis plants. Fitbits will be used to track and report on sleep quality and levels of participants through the Curebase platform, along with other physical and activity metrics.
To help recruit Veterans for the trial, Curebase and LEVEL partnered with several Veterans' advocacy groups, including the Veterans Cannabis Group, Operation EVAC, and the Santa Cruz Veterans Alliance.
"While this is a fully virtual trial, we wanted that front door to be through an organization that Veterans know and trust," said LEVEL founder and CEO Chris Emerson, himself a Veteran of the U.S. Navy. "Combining the work of these terrific Veterans' organizations with Curebase's trial platform and virtual study staff, we're able to focus on connecting Veterans with the clinical aspects and benefits of the study remotely, while feeling closely supported by real people from our Veteran partners and Curebase's research staff."
Curebase's decentralized clinical trial model ensures more diverse studies because unique populations – which typically are underrepresented in clinical trials – can be included. The decentralized platform makes it easy for Veterans to participate, no matter where they are located, in addition to providing them proactive and real-time support through the use of data empowered virtual research coordinators. The Curebase platform and virtual site empowers sponsors, CROs and physicians from practices of all sizes to conduct clinical research, including private practices, independent clinics, and large academic research sites.
LEVEL's mission is to create unique, targeted effects-based cannabis products by formulating cannabinoids in ratios not accessible from the plant alone and at consistent levels of purity and desired effects. The company hopes to destigmatize cannabis use and encourage continued clinical research into its potential benefits.
Curebase is reinventing decentralized clinical trials to help the vast majority of potential patients that currently cannot access clinical research. Our vision is that any patient, no matter where they are located, should be able to participate in clinical trials at home and with their own doctors. This is made possible through a unique suite of tools Curebase’s has designed to engage patients in clinical trials across all settings, be it at home, at their local clinic, or other places in their community.
This starts with Curebase’s leading decentralized clinical trial software platform that is an all-in-one, purpose built eClinical software system, with every tool needed to manage and collect data for decentralized clinical trials. This includes ePRO, eCOA, eConsent, Telemedicine, and much more. Curebase also offers a virtual research site, complete with virtual investigators, research coordinators, mobile nursing, and other healthcare staff that administer care to patients where convenient for them, just like any other research site, but with the ability to stand up anywhere and with greater patient convenience and reach. Notably, Curebase is the pioneer of the “BYOP” or Bring Your Own Physician model, allowing patients to use their own doctors to participate in clinical trials.
We are reinventing a $45B market, enabling drug and device companies to increase the volume, quality, and speed of data collection regardless of patients’ physical location. COVID-19 tailwinds have created massive demand for telemedicine and home-based trials, with two new FDA guidance letters and industry-wide adoption of remote remote research that will only accelerate in the years to come. You can learn more about Curebase and our next stage of growth in Crunchbase, Fierce Biotech, and MedCity News!
LEVEL is a cannabinoid research and development company that is unlocking the true potential of cannabis to deliver brand-new highs with targeted effects. LEVEL formulates with cannabinoids you don't often hear about (CBG, CBN, THCa,THCv, Delta-8 THC) as well as the ones you do (Delta-9 THC and CBD) into swallowable and dissolvable tablets. LEVEL's products are scientifically designed to deliver the desired effect, every time. Whether you're looking to focus on a project, get a good night's sleep, prevent a hangover, relieve stress, or soothe aches and pains, there's a unique cannabinoid profile for that. We crafted the range of doses and intake methods we offer with the intention of providing tools that help you discover what your body responds to best—no matter your experience level with cannabis.
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