Medical Cannabis for Chronic Pain

(OMNI-Can Trial)

Recruiting in Palo Alto (17 mi)

+15 other 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.

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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.

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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).

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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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

OMNI Medical Services Pompano Beach, FL

OMNI Medical Services Toledo, OH

OMNI Medical Services Bradenton, FL

OMNI Medical Services Wesley Chapel, FL

More Trial Locations

Who Is Running the Clinical Trial?

OMNI Medical Services, LLC Lead Sponsor

OMNI Medical Services Inc Collaborator

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] Introduction: Although cannabis is widely used for the treatment of chronic pain, most research relies on patient self-report and few studies have objectively quantified its efficacy and side effects. Extant inventories for measuring cannabis use were not designed to capture the medically relevant features of cannabis use, but rather were designed to detect problematic use or cannabis use disorder. Thus, we sought to capture the medically relevant features of cannabis use in a population of patients with orthopedic pain and pair these data with objective measures of pain and prescription drug use. Materials and Methods: In this prospective observational study, orthopedic pain patients were enrolled in Pennsylvania's medical cannabis program by their treating pain management physician, received cannabis education from their physician at the time of certification, and purchased products from state-licensed cannabis retailers. Results: Medical cannabis use was associated with clinical improvements in pain, function, and quality of life with reductions in prescription drug use; 73% either ceased or decreased opioid consumption and 31% discontinued benzodiazepines. Importantly, 52% of patients did not experience intoxication as a side effect of cannabis therapy. Significant clinical benefits of cannabis occurred within 3 months of initiating cannabis therapy and plateaued at the subsequent follow-ups. Conclusions: This work provides a direct relationship between the initiation of cannabis therapy and objectively fewer opioid and benzodiazepine prescriptions. Our work also identifies specific subpopulations of patients for whom cannabis may be most efficacious in reducing opioid consumption, and it highlights the importance of both physician involvement and patient self-titration in symptom management with cannabis.

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

Clinical Profiles of Concurrent Cannabis Use in Chronic Pain: A CHOIR Study. [2021] Despite evidence of the analgesic benefits of cannabis, there remains a relative scarcity of research on the short- and long-term effects of cannabis use in individuals with chronic pain.

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

Cannabis for Chronic Pain: Challenges and Considerations. [2019] The National Academies of Sciences, Engineering, and Medicine has found substantial evidence that cannabis (plant) is effective for the treatment of chronic pain in adults, and moderate evidence that oromucosal cannabinoids (extracts, especially nabiximols) improve short-term sleep disturbances in chronic pain. The paradoxical superiority of the cannabis plant over cannabinoid molecules represents a challenge for the medical community and the established processes that define modern pharmacy. The expanding and variable legalization of cannabis in multiple states nationwide represents an additional challenge for patients and the medical community because recreational and medicinal cannabis are irresponsibly overlapped. Cannabis designed for recreational use (containing high levels of active ingredients) is increasingly available to patients with chronic pain who do not find relief with current pharmacologic entities, which exposes patients to potential harm. This article analyzes the available scientific evidence to address controversial questions that the current state of cannabis poses for health care professionals and chronic pain patients and sets the basis for a more open discussion about the role of cannabis in modern medicine for pain management. A critical discussion on these points, the legal status of cannabis, and considerations for health care providers is presented.

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] There is an increasing interest in the medical use of cannabis, particularly in the treatment of chronic pain.

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

The Quebec Cannabis Registry: Investigating the Safety and Effectiveness of Medical Cannabis. [2023] Objective: To investigate the safety and effectiveness of medical cannabis (MC) in the real-world clinical practice setting. Design: A 4-year prospective noncomparative registry of adult patients who initiated MC for a variety of indications. This paper reports on patients followed for up to 12 months, with interim visits at 3, 6, and 9 months after enrollment. Setting: Public or private outpatient clinics certified to authorize MC in the province of Quebec, Canada. Participants: Overall, 2991 adult (age ≥18 years) patients (mean age 51 years; 50.2% women) were enrolled between May 2015 and October 2018, with the last follow-up ending in May 2019. Interventions/Exposures: Cannabis products (dried, oil, or other) purchased from a Canadian licensed cannabis producer as authorized by physicians. Main Outcome Measures: The primary outcomes were self-reported pain severity, interference and relief (Brief Pain Inventory [BPI]), symptoms using the Revised Edmonton Symptom Assessment System (ESAS-r) and health-related quality of life dimensions (EQ-5D-5L) at baseline and each follow-up visit. The secondary outcomes were self-reported adverse events (AEs) and characteristics of cannabis treatment. Results: All patient-reported outcomes (BPI, ESAS-r, and EQ-5D-5L) showed a statistically significant improvement at 3 months (all p<0.01), which was maintained or further improved (for pain interference, tiredness, and well-being) over the remainder of the 12-month follow-up. Results also revealed clinically significant improvements in pain interference and tiredness, anxiety, and well-being from baseline. There were 79 AE reports (77 patients), 16 met the regulatory definition of seriousness, in which only 8 AEs were certainly or probably related to MC. Conclusions: MC directed by physicians appears to be safe and effective within 3 months of initiation for a variety of medical indications.

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

A Retrospective Medical Record Review of Adults with Non-Cancer Diagnoses Prescribed Medicinal Cannabis. [2023] Research describing patients using medicinal cannabis and its effectiveness is lacking. We aimed to describe adults with non-cancer diagnoses who are prescribed medicinal cannabis via a retrospective medical record review and assess its effectiveness and safety. From 157 Australian records, most were female (63.7%; mean age 63.0 years). Most patients had neurological (58.0%) or musculoskeletal (24.8%) conditions. Medicinal cannabis was perceived beneficial by 53.5% of patients. Mixed-effects modelling and post hoc multiple comparisons analysis showed significant changes overtime for pain, bowel problems, fatigue, difficulty sleeping, mood, quality of life (all p < 0.0001), breathing problems (p = 0.0035), and appetite (p = 0.0465) Symptom Assessment Scale scores. For the conditions, neuropathic pain/peripheral neuropathy had the highest rate of perceived benefit (66.6%), followed by Parkinson's disease (60.9%), multiple sclerosis (60.0%), migraine (43.8%), chronic pain syndrome (42.1%), and spondylosis (40.0%). For the indications, medicinal cannabis had the greatest perceived effect on sleep (80.0%), followed by pain (51.5%), and muscle spasm (50%). Oral oil preparations of balanced delta-9-tetrahydrocannabinol/cannabidiol (average post-titration dose of 16.9 mg and 34.8 mg per day, respectively) were mainly prescribed. Somnolence was the most frequently reported side effect (21%). This study supports medicinal cannabis' potential to safely treat non-cancer chronic conditions and indications.

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

A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry. [2023] Published data on the safety of natural medical cannabis (MC) when used in the real-world clinical practice setting are lacking. This study aimed to describe adverse events (AEs) reported across three years following MC initiation.

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

Adverse events following cannabis for medical use in Tuscany: An analysis of the Italian Phytovigilance database. [2021] Despite a significant increase in using cannabis for medical purposes, current evidence on its safety in real-world clinical practice is still poorly characterised. By a case-by-case analysis of spontaneous reports of suspected adverse events (AEs) collected in Tuscany within the Italian Phytovigilance database, the aim of the present study was to describe AEs occurred in patients exposed to medical cannabis.

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

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). [2022] Cannabis is widely used as a self-management strategy by patients with a wide range of symptoms and diseases including chronic non-cancer pain. The safety of cannabis use for medical purposes has not been systematically evaluated. We conducted a prospective cohort study to describe safety issues among individuals with chronic non-cancer pain. A standardized herbal cannabis product (12.5% tetrahydrocannabinol) was dispensed to eligible individuals for a 1-year period; controls were individuals with chronic pain from the same clinics who were not cannabis users. The primary outcome consisted of serious adverse events and non-serious adverse events. Secondary safety outcomes included pulmonary and neurocognitive function and standard hematology, biochemistry, renal, liver, and endocrine function. Secondary efficacy parameters included pain and other symptoms, mood, and quality of life. Two hundred and fifteen individuals with chronic pain were recruited to the cannabis group (141 current users and 58 ex-users) and 216 controls (chronic pain but no current cannabis use) from 7 clinics across Canada. The median daily cannabis dose was 2.5 g/d. There was no difference in risk of serious adverse events (adjusted incidence rate ratio = 1.08, 95% confidence interval = .57-2.04) between groups. Medical cannabis users were at increased risk of non-serious adverse events (adjusted incidence rate ratio = 1.73, 95% confidence interval = 1.41-2.13); most were mild to moderate. There were no differences in secondary safety assessments. Quality-controlled herbal cannabis, when used by patients with experience of cannabis use as part of a monitored treatment program over 1 year, appears to have a reasonable safety profile. Longer-term monitoring for functional outcomes is needed.

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] Medical cannabis is one of the most commonly reported treatments for chronic pain. The wide acceptance and research in alternative medicine have put medical cannabis in the limelight, where researchers are widely examining its therapeutic benefits, including treatment of chronic pain.

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] Cannabis is increasingly available for the treatment of chronic pain, yet its efficacy remains uncertain.

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

Pills to Pot: Observational Analyses of Cannabis Substitution Among Medical Cannabis Users With Chronic Pain. [2020] Chronic pain is common, costly, and challenging to treat. Many individuals with chronic pain have turned to cannabis as an alternative form of pain management. We report results from an ongoing, online survey of medical cannabis users with chronic pain nationwide about how cannabis affects pain management, health, and pain medication use. We also examined whether and how these parameters were affected by concomitant recreational use, and duration of use (novice:

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] Medical cannabis (MC) is commonly claimed to be an effective treatment for chronic or refractory pain. With interest in MC in the United States growing, as evidenced by the 29 states and 3 US districts that now have public MC programs, the need for clinical evidence supporting this claim has never been greater.