Coaching Sessions for Chronic Pain

Overseen By Kevin Boehnke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: Cannabis products

Disqualifiers: Psychotic disorder, Bipolar, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

468 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of the MIVetsCan Can-Coach Trial is to test four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on helping you use cannabis products more effectively for pain management.

What evidence supports the effectiveness of the treatment Can-Coach, Cannabis Coaching, Cannabis Therapy, Medical Cannabis Treatment for chronic pain?

Research shows that cannabis-based treatments can provide some pain relief for chronic pain, with a small percentage of patients experiencing significant improvement. However, the overall effectiveness is limited, and there are potential side effects like dizziness and dry mouth. ^{1 2 3 4 5}

Is the use of medical cannabis generally safe for humans?

Research shows that medical cannabis, when used under physician guidance, appears to be generally safe for a variety of medical conditions, with most adverse effects being mild to moderate. However, there is a need for long-term safety monitoring to better understand its effects. ^{6 7 8 9 10}

How is the Can-Coach treatment different from other chronic pain treatments?

Can-Coach is unique because it combines medical cannabis with coaching sessions, which may help improve pain management, anxiety, sleep, and quality of life. Unlike standard treatments, it offers a holistic approach by addressing both physical symptoms and emotional well-being. ^{1 11 12 13 14}

Research Team

Kevin Boehnke, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for Veterans experiencing chronic pain who are interested in learning how to better use their own cannabis products for symptom management. Specific eligibility details are not provided.

Inclusion Criteria

Willingness to fill out periodic assessments via smartphone to assess symptom status and cannabis use (protocol has more details)

I experience moderate to severe chronic pain.

I have been in pain for 3 or more months.

Exclusion Criteria

Current diagnosis or past history of bipolar disorder

Risk for imminent harm - Suicidal ideation or wish to die as assessed with the Positive and Negative Suicide Ideation (PANSI) questionnaire and further risk assessment by study team members

Participant states participant is pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Education

Participants receive immediate education sessions starting around week 4

8 weeks

4 virtual sessions

Waitlist Control

Participants in the waitlist control group receive delayed education starting around week 12

2 weeks

2 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after education sessions

4 weeks

Treatment Details

Interventions

• Can-Coach

Trial Overview The MIVetsCan Can-Coach Trial is evaluating the effectiveness of four educational coaching sessions designed to assist Veterans with chronic pain in using cannabis more effectively.

Participant Groups

Group I: Waitlist Control - delayed education Experimental Treatment 1 Intervention

Education sessions starting \~ week 12 of trial

Group II: Immediate Education Experimental Treatment 1 Intervention

Education sessions starting \~ week 4 of trial

Can-Coach is already approved in Canada for the following indications:

Approved in Canada as Medical Cannabis for:

• Chronic Pain
• Post-traumatic Stress Disorder (PTSD)
• Anxiety
• Insomnia

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Michigan, State of, Licensing and Regulatory Affairs

Collaborator

Trials

3

Recruited

960+

Findings from Research

A review of 104 studies involving nearly 10,000 participants found that cannabinoids provided a modest benefit in reducing chronic noncancer pain, with a 30% pain reduction rate of 29.0% compared to 25.9% for placebo, indicating a significant but limited efficacy.

The analysis revealed a high number needed to treat (NNT) to benefit of 24, suggesting that cannabinoids may not be highly effective for chronic noncancer pain, especially considering the relatively high rate of adverse events (81.2% for cannabinoids vs. 66.2% for placebo).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis and cannabinoids for the treatment of people with chronic noncancer pain conditions: a systematic review and meta-analysis of controlled and observational studies. Stockings, E., Campbell, G., Hall, WD., et al.[2019]

Recent systematic reviews show that while there is moderate quality evidence for cannabis medicines providing moderate relief for neuropathic pain, they are generally considered a third-line treatment option.

The conclusions of these reviews can be influenced by the thoroughness of literature searches and study inclusion criteria, with many studies indicating a lack of efficacy for other types of chronic pain, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evidence of the efficacy and safety of cannabis medicines for chronic pain management : A methodological minefield]. Häuser, W., Petzke, F.[2019]

In a study of 2,112 adult patients with chronic pain, 92.5% reported improvement in their primary symptoms after using cannabis-based oral formulations, indicating high efficacy as an adjuvant treatment.

The majority of patients experienced minimal side effects, with 71.7% reporting none, and the most common mild side effects, such as somnolence and dizziness, tended to decrease over time, suggesting that these formulations are safe for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex-Dependent Prescription Patterns and Clinical Outcomes Associated With the Use of Two Oral Cannabis Formulations in the Multimodal Management of Chronic Pain Patients in Colombia. Moreno-Sanz, G., Madiedo, A., Hernandez, P., et al.[2022]

In a 12-month study involving 751 chronic pain patients, plant-based medical cannabis significantly reduced pain severity and interference, with improvements observed as early as one month and maintained throughout the year.

Patients also experienced enhanced physical and mental health, along with reduced use of opioid medications, suggesting that medical cannabis can be a safe and effective alternative or complement to traditional pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Cannabis for the Management of Pain and Quality of Life in Chronic Pain Patients: A Prospective Observational Study. Safakish, R., Ko, G., Salimpour, V., et al.[2021]

In a survey of 209 patients with chronic non-cancer pain, 15% reported using cannabis for pain relief, with the majority seeking relief from trauma or surgery-related pain, indicating a notable prevalence of cannabis use in this population.

Patients using cannabis for pain relief reported improvements in pain, sleep, and mood, but also experienced common side effects like feeling 'high' and dry mouth, highlighting the need for discussions between patients and healthcare providers about its use and potential interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis use for chronic non-cancer pain: results of a prospective survey. Ware, MA., Doyle, CR., Woods, R., et al.[2022]

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]

The safety of cannabis and cannabinoid medications is a significant concern, and while some safety information can be drawn from recreational use studies, medical and recreational users may experience different effects.

There is a pressing need for long-term safety monitoring of cannabinoid use in patients, as clinical experience is still developing, which will help inform both therapeutic decisions and public policy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues concerning the medical use of cannabis and cannabinoids. Ware, MA., Tawfik, VL.[2019]

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]

A systematic review identified 12 publications recommending medical cannabis for chronic noncancer pain (CNCP), with most recommendations based on systematic reviews and expert consensus, particularly for conditions like neuropathic pain and chronic pain in HIV patients.

Despite the support for medical cannabis, the recommendations are considered weak, suggesting it should be used as a third- or fourth-line therapy, emphasizing the need for thorough discussions with patients about potential benefits and risks before prescribing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Cannabis for Chronic Noncancer Pain: A Systematic Review of Health Care Recommendations. Chang, Y., Zhu, M., Vannabouathong, C., et al.[2023]

Health Canada has implemented new regulations for medical cannabis, making it illegal for individuals to produce their own cannabis, while allowing 26 licensed producers to offer over 200 strains across Canada.

Recent clinical trials suggest that cannabinoids can be modestly effective for managing chronic non-cancer-related pain, indicating they are a safe therapeutic option, but further clinical confirmation and education on their use are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical cannabis: considerations for the anesthesiologist and pain physician. Beaulieu, P., Boulanger, A., Desroches, J., et al.[2017]

In a 3-month study involving 46 adults with chronic pain, medical cannabis significantly reduced pain intensity and anxiety, while improving sleep duration and quality after just a few weeks of treatment.

At the 3-month follow-up, participants reported lower levels of worst pain, pain interference, and depression, along with enhanced sleep quality and overall quality of life, indicating the potential long-term benefits of medical cannabis for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Outcomes among Adults Initiating Medical Cannabis for Chronic Pain: A 3-month Prospective Study Incorporating Ecological Momentary Assessment (EMA). Wang, Y., Jean Jacques, J., Li, Z., et al.[2023]

A rapid systematic review of 13 randomized controlled trials involving 1352 individuals with chronic pain found that cannabinoids may provide moderate analgesic effects for chronic neuropathic pain, although results were inconsistent across studies.

Cannabinoids appear to be relatively safe for use in chronic pain management, with few severe adverse events reported, suggesting they could be a potential treatment option alongside other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis for Chronic Pain: A Rapid Systematic Review of Randomized Control Trials. Longo, R., Oudshoorn, A., Befus, D.[2021]

Cannabis-based medicines may be considered for chronic neuropathic pain, but should only be used by experienced clinicians as part of a multidisciplinary treatment plan, especially when standard therapies have not been effective.

For other types of chronic pain, such as cancer or non-neuropathic pain, cannabis should be treated as an individual trial, with close monitoring for efficacy and potential adverse effects, and treatment should be stopped if predefined goals are not met.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European Pain Federation (EFIC) position paper on appropriate use of cannabis-based medicines and medical cannabis for chronic pain management. Häuser, W., Finn, DP., Kalso, E., et al.[2019]

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

Cannabis and cannabinoids for the treatment of people with chronic noncancer pain conditions: a systematic review and meta-analysis of controlled and observational studies. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

[Evidence of the efficacy and safety of cannabis medicines for chronic pain management : A methodological minefield]. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Sex-Dependent Prescription Patterns and Clinical Outcomes Associated With the Use of Two Oral Cannabis Formulations in the Multimodal Management of Chronic Pain Patients in Colombia. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Medical Cannabis for the Management of Pain and Quality of Life in Chronic Pain Patients: A Prospective Observational Study. [2021]

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

Cannabis use for chronic non-cancer pain: results of a prospective survey. [2022]

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

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

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

Safety issues concerning the medical use of cannabis and cannabinoids. [2019]

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

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

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

Medical Cannabis for Chronic Noncancer Pain: A Systematic Review of Health Care Recommendations. [2023]

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

Medical cannabis: considerations for the anesthesiologist and pain physician. [2017]

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

Health Outcomes among Adults Initiating Medical Cannabis for Chronic Pain: A 3-month Prospective Study Incorporating Ecological Momentary Assessment (EMA). [2023]

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

Cannabis for Chronic Pain: A Rapid Systematic Review of Randomized Control Trials. [2021]

13. England pubmed.ncbi.nlm.nih.gov

European Pain Federation (EFIC) position paper on appropriate use of cannabis-based medicines and medical cannabis for chronic pain management. [2019]

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

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