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Cannabinoid

Medical Cannabis for Chronic Pain (OMNI-Can Trial)

Phase 2
Recruiting
Led By Dr. Ryan O Lakin, MD JD
Research Sponsored by OMNI Medical Services, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of a Qualifying Condition for Medical Marijuana
Timeline
Screening 3 weeks
Treatment Varies
Follow Up five years
Awards & highlights

OMNI-Can Trial Summary

This trial will test the effectiveness and safety of medical cannabis for various chronic medical conditions.

Who is the study for?
Adults diagnosed with a variety of chronic conditions like pain, brain injuries, mental health disorders, and more may qualify if they can use medical marijuana legally. They must be able to complete online surveys throughout the study. Minors need guardian consent. Pregnant or breastfeeding individuals, those unable to consent, or at risk of worsened psychosis or suicidality from cannabis are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness and safety of medical cannabis delivered via RYAH-Medtech Inhaler for treating multiple chronic conditions across several states and centers.See study design
What are the potential side effects?
While not specified here, common side effects of medical cannabis can include dizziness, dry mouth, altered senses or mood changes; however individual experiences may vary.

OMNI-Can Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a condition that qualifies for medical marijuana.

OMNI-Can Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~five years
This trial's timeline: 3 weeks for screening, Varies for treatment, and five years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prevention of COVID-19
Treatment of COVID-19
Treatment of Symptoms
Secondary outcome measures
Cannabis Impact on Quality of Life
Cannabis Route and Dosing
Monitoring Adverse Events

OMNI-Can Trial Design

4Treatment groups
Experimental Treatment
Group I: Life-Threatening ConditionsExperimental Treatment2 Interventions
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.
Group II: Cannabis usersExperimental Treatment2 Interventions
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.
Group III: Cancer preventionExperimental Treatment2 Interventions
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.
Group IV: COVID-19 / SARS-CoV-2Experimental Treatment2 Interventions
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.

Find a Location

Who is running the clinical trial?

OMNI Medical Services, LLCLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
OMNI Medical Services IncUNKNOWN
Dr. Ryan O Lakin, MD JDPrincipal InvestigatorOMNI Medical Services Inc

Media Library

Medical Cannabis (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT03944447 — Phase 2
Epilepsy Research Study Groups: Life-Threatening Conditions, COVID-19 / SARS-CoV-2, Cannabis users, Cancer prevention
Epilepsy Clinical Trial 2023: Medical Cannabis Highlights & Side Effects. Trial Name: NCT03944447 — Phase 2
Medical Cannabis (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03944447 — Phase 2
Epilepsy Patient Testimony for trial: Trial Name: NCT03944447 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a groundbreaking clinical trial?

"Presently, 31 active trials for Cannabis, Medical are scattered across 32 cities and 5 countries. It all started with a 200-patient trial conducted by Jazz Pharmaceuticals in 2015; since then 60 similar studies have concluded. This particular experiment made its way through the Phase 2 & 3 drug approval process."

Answered by AI

What is the total population size for this clinical research project?

"Affirmative, clinicaltrials.gov displays that this investigation—initially published on December 1st 2018—is presently looking for volunteers. Two hundred thousand subjects need to be enrolled from 16 distinct locations."

Answered by AI

Are there any remaining vacancies for this experiment in human subjects?

"This clinical study is actively looking for participants, as indicated on the information posted to clinicaltrials.gov. The trial was initiated on December 1st 2018 and has had its details amended more recently on May 29th 2022."

Answered by AI

How widely spread is the implementation of this clinical trial?

"At the moment, this clinical trial is being managed across 16 sites located in various cities, including Fort Lauderdale, Boca Raton and Merritt Island. For convenience sake, it may be useful to select a clinic that requires minimal travel if you wish to enroll."

Answered by AI

Could you please elucidate the potential risks of Medical Cannabis to patients?

"Our team at Power has assigned a safety rating of 2 to cannabis-based medicine, as it is currently undergoing Phase 2 testing and there is limited evidence regarding its efficacy."

Answered by AI

Have there been other scholarly investigations into the therapeutic efficacy of Cannabis?

"At present, there are 31 active clinical trials concerning Cannabis Medical. Of those, 3 of them are in their final phase. Most of the sites conducting these experiments can be found in Hartford, Connecticut; however, that number rises to 46 when accounting for other locations across America."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Ohio
Other
Florida
How old are they?
65+
18 - 65
What site did they apply to?
OMNI Medical Services
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
3+

What questions have other patients asked about this trial?

What form is it? When can I start? Is it a paid trial? Is this a paid trial?
PatientReceived 2+ prior treatments
How long is the trial?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I don't sleep. I am in constant pain. To verify that it works. I've tried everything else.
PatientReceived 1 prior treatment
WANT A BETTER QUALITY OF LIFE.
PatientReceived 1 prior treatment
~47619 spots leftby Dec 2025