Depression Clinical Trial
— OMNI-CanOfficial title:
Outcomes Mandate National Integration With Cannabis as Medicine
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.
Status | Recruiting |
Enrollment | 200000 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | OMNI Medical Services | Beechwood | Ohio |
United States | OMNI Medical Services | Boca Raton | Florida |
United States | OMNI Medical Services | Bowling Green | Ohio |
United States | OMNI Medical Services | Bradenton | Florida |
United States | OMNI Medical Services | Fort Lauderdale | Florida |
United States | OMNI Medical Services | Fort Myers | Florida |
United States | OMNI Medical Services | Gainesville | Florida |
United States | OMNI Medical Services | Merritt Island | Florida |
United States | OMNI Medical Services | Miami | Florida |
United States | OMNI Medical Services | Ocoee | Florida |
United States | OMNI Medical Services | Pensacola | Florida |
United States | OMNI Medical Services | Pompano Beach | Florida |
United States | OMNI Medical Services | Sandusky | Ohio |
United States | OMNI Medical Services | Tampa | Florida |
United States | OMNI Medical Services | Toledo | Ohio |
United States | OMNI Medical Services | Toledo | Ohio |
United States | OMNI Medical Services | Wesley Chapel | Florida |
Lead Sponsor | Collaborator |
---|---|
OMNI Medical Services, LLC | OMNI Medical Services Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevention of COVID-19 | Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu). | Five years | |
Primary | Treatment of COVID-19 | Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2). | Five years | |
Primary | Treatment of Symptoms | The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves. | Five years | |
Secondary | Cannabis Impact on Quality of Life | Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals. | Five years | |
Secondary | Cannabis Route and Dosing | Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest. | Five years | |
Secondary | Monitoring Adverse Events | Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0. | Five years |
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