What is the mechanism of action of this treatment?

The most common treatments for epilepsy include antiepileptic drugs (AEDs) such as carbamazepine, lamotrigine, and valproate. These medications primarily work by stabilizing neuronal membranes and reducing excitability through various mechanisms, such as blocking sodium channels, enhancing GABAergic inhibition, or inhibiting calcium channels. Medical cannabis, which interacts with the endocannabinoid system, offers a different approach by modulating neurotransmitter release and reducing neuronal excitability through cannabinoid receptors (CB1 and CB2). This is particularly relevant for epilepsy patients as it provides an alternative mechanism to control seizures, especially for those who are resistant to traditional AEDs.

What side effects are associated with this type of intervention?

Common treatments for epilepsy, such as anticonvulsants and cannabinoids, have a range of side effects. Anticonvulsants like topiramate and gabapentin can cause dizziness, confusion, impaired concentration, and mood changes. Cannabinoids, including cannabidiol (CBD) and synthetic cannabinoids like nabilone, may lead to dizziness, sedation, confusion, and dissociation. Despite these adverse effects, some patients prefer cannabinoids due to their potential benefits in pain and seizure management.

What prior FDA approvals exist?

The FDA has approved cannabidiol (CBD) for the treatment of epilepsy, specifically for conditions like Dravet syndrome and Lennox-Gastaut syndrome. Epidiolex, a pharmaceutical formulation of CBD, is the primary drug approved for these indications. This approval is based on clinical trials demonstrating its efficacy in reducing seizure frequency. Other treatments for epilepsy that do not directly interact with the endocannabinoid system include traditional antiepileptic drugs like levetiracetam, carbamazepine, and valproate.

What other types of research exist?

Promising novel alternatives to medical cannabis for epilepsy patients include: 1) N-acetylcysteine (NAC), which has shown potential in a randomized controlled pilot trial for children with autism, indicating possible benefits for neurological conditions; 2) Topiramate, which has been used as an add-on drug in severe myoclonic epilepsy in infancy (Dravet syndrome) with positive outcomes; 3) Gabapentin, which has demonstrated efficacy in reducing cannabis use and improving cognitive function, suggesting potential benefits for epilepsy management. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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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

Must not have

Active suicidality or psychosis, that could be exacerbated by the administration of cannabis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up five years

Awards & highlights

Summary

This trial will investigate if medical cannabis can effectively reduce pain and improve quality of life for patients with chronic conditions. The study will gather data through an online questionnaire about patients' use of cannabis and its effects. Medical cannabis interacts with the body's natural system to help manage pain and other symptoms. Medical cannabis has been increasingly studied and used as an alternative treatment for managing chronic pain, with numerous studies supporting its potential benefits.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have active thoughts of suicide or severe mental health issues that could worsen with cannabis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ five years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prevention of COVID-19

Treatment of COVID-19

Treatment of Symptoms

Secondary study objectives

Cannabis Impact on Quality of Life

Cannabis Route and Dosing

Monitoring Adverse Events

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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for epilepsy include antiepileptic drugs (AEDs) such as carbamazepine, lamotrigine, and valproate. These medications primarily work by stabilizing neuronal membranes and reducing excitability through various mechanisms, such as blocking sodium channels, enhancing GABAergic inhibition, or inhibiting calcium channels. Medical cannabis, which interacts with the endocannabinoid system, offers a different approach by modulating neurotransmitter release and reducing neuronal excitability through cannabinoid receptors (CB1 and CB2). This is particularly relevant for epilepsy patients as it provides an alternative mechanism to control seizures, especially for those who are resistant to traditional AEDs.

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

Opioid Use Disorder Research Study Groups: Life-Threatening Conditions, COVID-19 / SARS-CoV-2, Cannabis users, Cancer prevention

Opioid Use Disorder 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

Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT03944447 — Phase 2

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