Medical Cannabis for Chronic Pain

(OMNI-Can Trial)

Recruiting at15 trial locations

Overseen by Ryan O Lakin, MD JD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: OMNI Medical Services, LLC

Disqualifiers: Pregnancy, Breastfeeding, Suicidality, Psychosis, others

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Medical Cannabis for chronic pain?

Research shows that medical cannabis can improve pain, function, and quality of life for people with chronic pain, with many patients reducing their use of prescription drugs like opioids and benzodiazepines. Additionally, significant improvements in pain relief and well-being were observed within 3 months of starting cannabis therapy. ^{1 2 3 4 5}

Is medical cannabis safe for treating chronic pain?

Research suggests that medical cannabis is generally safe for treating chronic pain, with most side effects being mild to moderate. Some studies report an increased risk of non-serious side effects like drowsiness, but serious side effects are rare. ^{5 6 7 8 9}

How is the drug medical cannabis unique in treating chronic pain?

Medical cannabis is unique for chronic pain treatment because it offers an alternative to traditional pain medications, potentially reducing the need for opioids and other painkillers. It is derived from the cannabis plant and may provide pain relief through its active compounds, like THC and CBD, which interact with the body's endocannabinoid system (a network of receptors that help regulate pain and other functions). ^{4 10 11 12 13}

Research Team

Ryan O Lakin, MD JD

Principal Investigator

OMNI Medical Services Inc

Eligibility Criteria

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 over 18 or have parental/legal guardian consent.

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

Trial Timeline

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

Treatment Details

Interventions

• Medical Cannabis (Cannabinoid)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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]

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]

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 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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Perceived Efficacy, Reduced Prescription Drug Use, and Minimal Side Effects of Cannabis in Patients with Chronic Orthopedic Pain. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Clinical Profiles of Concurrent Cannabis Use in Chronic Pain: A CHOIR Study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Cannabis for Chronic Pain: Challenges and Considerations. [2019]

4. Italy 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. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The Quebec Cannabis Registry: Investigating the Safety and Effectiveness of Medical Cannabis. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Retrospective Medical Record Review of Adults with Non-Cancer Diagnoses Prescribed Medicinal Cannabis. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Adverse events following cannabis for medical use in Tuscany: An analysis of the Italian Phytovigilance database. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). [2022]

10. Canada 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. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

The Effects of Cannabis Among Adults With Chronic Pain and an Overview of General Harms: A Systematic Review. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Pills to Pot: Observational Analyses of Cannabis Substitution Among Medical Cannabis Users With Chronic Pain. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of the efficacy, safety, and costs associated with the treatment of chronic pain with medical cannabis. [2022]