Medical Cannabis for Chronic Pain

(OMNI-Can Trial)

Recruiting at 15 trial locations

Overseen By Dr. Ryan O Lakin, MD JD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: OMNI Medical Services, LLC

Disqualifiers: Pregnancy, Breastfeeding, Suicidality, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Five years

200000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of medical cannabis for various chronic medical conditions. Researchers will examine cannabis as an alternative to opioids for severe pain, its effects on COVID-19 symptoms, potential cancer prevention, and general patterns among cannabis users. Individuals with a qualifying medical condition for medical marijuana who are willing to complete online surveys may be suitable candidates. The goal is to determine if cannabis can provide a safer or more effective treatment option compared to other medicines. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that medical cannabis can help manage chronic pain. Some studies found it can lessen pain and improve patients' quality of life. However, safety concerns exist. For example, one study found that people using cannabis for chronic pain experienced more side effects than those who didn't use it.

These side effects can include dizziness, dry mouth, or fatigue. Medical cannabis is already used for some conditions, suggesting it is generally safe. Since this trial is in an early stage, researchers are still determining the treatment's safety for different chronic conditions. Prospective participants should consult a healthcare provider about the possible risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about medical cannabis for chronic pain because it offers a potential alternative to opioids, which are highly addictive and have led to a significant number of overdose deaths. Unlike opioids, cannabis contains cannabinoids like CBD, which may provide pain relief without the risk of addiction or severe side effects. Additionally, cannabis has anti-inflammatory properties, which might also help in conditions beyond pain relief, such as reducing inflammation or potentially preventing certain diseases. This makes cannabis a promising candidate for safer, multi-faceted treatment options.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that medical cannabis can help manage chronic pain. In one study, more than 80% of patients reported pain relief. Another study found it more effective than prescription drugs for chronic pain over three months. Unlike opioids, medical cannabis also positively affects other pain-related issues. Real-world data suggest it lowers pain levels and improves quality of life. Overall, many people using medical cannabis for chronic pain report significant benefits. This trial will assess participants for outcomes related to medical cannabis use in various contexts, including as a replacement for opioids and its effects on COVID-19 symptoms and cancer prevention. ^{4 5 6 7 8}

Who Is on the Research Team?

Ryan O Lakin, MD JD

Principal Investigator

OMNI Medical Services Inc

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing to complete online surveys for this study.

I have a condition that qualifies for medical marijuana.

Exclusion Criteria

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

Pregnancy

Inability to complete study visits or questionnaires

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medical cannabis as a replacement or alternative to opioids or other prescription drugs. The study will assess efficacy and safety for chronic pain and other conditions.

Five years

Online surveys at 3, 6, 9, and 12 months, with annual follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on COVID-19 infection rates and severity of symptoms.

Five years

Annual follow-up surveys

Extension

Participants may continue to be monitored for long-term outcomes related to cannabis use, including cancer prevention and quality of life metrics.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Medical Cannabis

Trial Overview 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.

How Is the Trial Designed?

Group I: Life-Threatening Conditions Experimental Treatment 2 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 users Experimental Treatment 2 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 prevention Experimental Treatment 2 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-2 Experimental Treatment 2 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.

Medical Cannabis is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Medical Cannabis for:

• Severe and chronic pain
• Multiple sclerosis and muscle spasms
• Severe nausea and vomiting caused by cancer treatment
• Epilepsy and seizures
• Alzheimer's disease
• Amyotrophic lateral sclerosis (ALS)
• HIV/AIDS
• Crohn's disease
• Glaucoma
• Migraine
• Anorexia
• Extreme weight loss and weakness (wasting syndrome)
• Irritable bowel syndrome
• Post-traumatic stress disorder

Approved in European Union as Cannabis-based medicinal products for:

• Severe epilepsy
• Multiple sclerosis
• Nausea and vomiting caused by cancer treatment

Approved in Canada as Medical Cannabis for:

• Severe pain
• Nausea and vomiting caused by cancer treatment
• Muscle spasms caused by multiple sclerosis
• Seizures caused by epilepsy

Who Is Running the Clinical Trial?

OMNI Medical Services, LLC

Lead Sponsor

Trials

2

Recruited

200,000+

OMNI Medical Services Inc

Collaborator

Trials

1

Recruited

200,000+

Published Research Related to This Trial

In a study of 29 patients with chronic pain, medical cannabis significantly improved quality of life and reduced pain levels after 3 months, as shown by substantial changes in EQ-5D and Pain Quality Assessment Scale scores.

The use of medical cannabis also led to a reduction in opioid consumption and associated costs, with only 10% of subjects reporting adverse effects, suggesting it may be a safe alternative for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of the efficacy, safety, and costs associated with the treatment of chronic pain with medical cannabis. Bellnier, T., Brown, GW., Ortega, TR.[2022]

In a study of 157 Australian adults using medicinal cannabis for non-cancer conditions, 53.5% reported it as beneficial, particularly for neuropathic pain and sleep issues, indicating its potential effectiveness for chronic conditions.

The most common side effect was somnolence (21%), suggesting that while medicinal cannabis can be a safe treatment option, monitoring for side effects is important.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Medical Record Review of Adults with Non-Cancer Diagnoses Prescribed Medicinal Cannabis. Morris, M., Chye, R., Liu, Z., et al.[2023]

In a survey of 1,321 medical cannabis users with chronic pain, about 80% reported substituting cannabis for traditional pain medications, particularly opioids, due to fewer side effects and better symptom management.

Experienced cannabis users (≥1 year) reported improved health and were less likely to take other pain medications compared to novice users (<1 year), suggesting that longer use may enhance the therapeutic benefits of cannabis in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pills to Pot: Observational Analyses of Cannabis Substitution Among Medical Cannabis Users With Chronic Pain. Boehnke, KF., Scott, JR., Litinas, E., et al.[2020]

A study involving 431 individuals with chronic non-cancer pain found that using a standardized herbal cannabis product for one year did not increase the risk of serious adverse events compared to non-users, suggesting a reasonable safety profile for medical cannabis.

However, cannabis users experienced a higher rate of non-serious adverse events, mostly mild to moderate, indicating that while cannabis may be safe for serious complications, it can still lead to some side effects that need to be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). Ware, MA., Wang, T., Shapiro, S., et al.[2022]

In a study of 1,668 patients with chronic pain, those who reported ongoing cannabis use experienced slightly worse sleep, higher pain intensity, and greater emotional distress compared to non-users, although these differences were small.

Longitudinal analysis showed no significant differences in changes to pain-related variables over time between cannabis users and non-users, suggesting that cannabis use may not impact the long-term trajectory of chronic pain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Profiles of Concurrent Cannabis Use in Chronic Pain: A CHOIR Study. Sturgeon, JA., Khan, J., Hah, JM., et al.[2021]

This scoping review analyzed 5 studies focusing on the perspectives of health professionals and medical cannabis users in New Zealand and Australia, highlighting the challenges they face with medical cannabis treatment for chronic pain.

The findings suggest that educating health professionals about medical cannabis could improve access and inform policy reforms, emphasizing the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analyzing the Perspectives of Health Professionals and Legal Cannabis Users on the Treatment of Chronic Pain With Cannabidiol: Protocol for a Scoping Review. Kumar, P., Mpofu, C., Wepa, D.[2023]

There is low-strength evidence from 27 trials that plant-based cannabis can help alleviate neuropathic pain, but there is insufficient evidence to support its effectiveness for other types of chronic pain.

Cannabis use is associated with potential harms, including an increased risk of motor vehicle accidents, psychotic symptoms, and short-term cognitive impairment, particularly in the general adult population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Cannabis Among Adults With Chronic Pain and an Overview of General Harms: A Systematic Review. Nugent, SM., Morasco, BJ., O'Neil, ME., et al.[2022]

In a study of 2991 patients over three years, only 3.6% experienced moderate or severe adverse events (AEs) after starting medical cannabis, indicating a relatively low incidence of serious side effects in real-world use.

Common mild AEs included dizziness, nausea, and somnolence, with variations depending on the method of consumption and cannabinoid content, suggesting that healthcare providers should consider these factors when prescribing medical cannabis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry. Hachem, Y., Moride, Y., Castilloux, AM., et al.[2023]

In a 4-year study involving 2991 adult patients using medical cannabis, significant improvements in pain severity, symptom relief, and quality of life were observed within 3 months, with benefits maintained or enhanced over 12 months.

The study reported a low incidence of adverse events, with only 8 out of 79 reported events deemed likely related to medical cannabis, suggesting that it is a safe treatment option when used under physician guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Quebec Cannabis Registry: Investigating the Safety and Effectiveness of Medical Cannabis. Vigano, A., Moride, Y., Hachem, Y., et al.[2023]

In a study analyzing 53 reports of adverse events related to medical cannabis in Tuscany, the majority of cases (73.6%) were classified as nonserious, with most patients experiencing complete resolution or improvement of symptoms.

The most common adverse events were related to psychiatric and nervous system disorders, indicating the need for careful monitoring during cannabis prescription, especially when patients are taking other medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events following cannabis for medical use in Tuscany: An analysis of the Italian Phytovigilance database. Crescioli, G., Lombardi, N., Bettiol, A., et al.[2021]

In a prospective observational study of orthopedic pain patients using medical cannabis, 73% reported a decrease or cessation of opioid use, and 31% stopped using benzodiazepines, indicating significant reductions in prescription drug reliance.

The study found that 52% of patients did not experience intoxication as a side effect, and clinical improvements in pain and quality of life were observed within 3 months of starting cannabis therapy, suggesting its efficacy and safety in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Efficacy, Reduced Prescription Drug Use, and Minimal Side Effects of Cannabis in Patients with Chronic Orthopedic Pain. Greis, A., Larsen, E., Liu, C., et al.[2023]

The National Academies of Sciences, Engineering, and Medicine found strong evidence that cannabis is effective for treating chronic pain in adults, and moderate evidence that oromucosal cannabinoids like nabiximols can improve sleep disturbances related to chronic pain.

The increasing availability of recreational cannabis, which often contains high levels of active ingredients, poses risks for patients seeking relief from chronic pain, highlighting the need for careful consideration and discussion among healthcare providers regarding its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis for Chronic Pain: Challenges and Considerations. Romero-Sandoval, EA., Fincham, JE., Kolano, AL., et al.[2019]

In a study of 338 patients over 12 months, the use of a 19% cannabis decoction significantly reduced pain intensity, pain disability, and symptoms of anxiety and depression, indicating its potential effectiveness in managing chronic pain.

Cannabis therapy, when used alongside traditional pain medications, may enhance the overall management of chronic pain and its psychological effects, although further randomized controlled trials are necessary to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Cannabis in Patients with Chronic Pain: Effect on Pain Relief, Pain Disability, and Psychological aspects. A Prospective Non randomized Single Arm Clinical Trial. Poli, P., Crestani, F., Salvadori, C., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39878633/

The comparative effectiveness of medicinal cannabis for ... Medical marijuana was comparatively more effective than prescription medications for the treatment of chronic pain at 3 months.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10361798/

Perceived Effectiveness of Medical Cannabis Among Adults ... Overall, most study participants reported medical cannabis effectively reduced their chronic pain, but several study participants mentioned not observing ...

3. marijuanamoment.net marijuanamoment.net/medical-marijuana-is-an-effective-treatment-option-for-chronic-pain-patients-improving-quality-of-life-new-study-shows/

Medical Marijuana Is An 'Effective Treatment Option' For ... “Over 80 percent of patients who turned to medical cannabis found it effective for managing their pain,” co-author Mohammad Khak, a researcher ...

4. jcannabisresearch.biomedcentral.com jcannabisresearch.biomedcentral.com/articles/10.1186/s42238-023-00207-7

The holistic effects of medical cannabis compared to opioids ... MC and opioids were perceived to be equally efficacious in reducing pain intensity, but MC additionally positively affected broader pain-related factors.

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/20503245231172535

Medicinal cannabis for pain: Real-world data on three- ... Preliminary evidence suggests that MC may be effective in reducing both pain severity and pain interference while also improving quality of life ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11940634/

Cannabinoids in Chronic Pain Management: A Review of the ... They demonstrated a reduction in opioid doses and a reduction in maximum pain intensity, as rated on a numeric rating scale, from an mean of 8.7 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1526590015008378

Cannabis for the Management of Pain: Assessment ... This study evaluated the safety of cannabis use by patients with chronic pain over 1 year. The study found that there was a higher rate of adverse events among ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2804653

Assessment of Medical Cannabis and Health-Related ... In this case series study, patients using medical cannabis reported improvements in health-related quality of life, which were mostly sustained over time.