87 Participants Needed

Medical Cannabis + Opioid Tapering for Chronic Pain

Recruiting at 2 trial locations
JG
Overseen ByJodi Gilman, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
Must be taking: Opioids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, any medications that may interact with cannabinoids will be discussed with a study clinician before enrollment or continued participation.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that any medications that may interact with cannabinoids will be discussed with a study clinician. It's best to talk to the study team about your specific medications.

What data supports the idea that Medical Cannabis + Opioid Tapering for Chronic Pain is an effective treatment?

The available research shows that using medical cannabis alongside opioid tapering can help manage chronic pain and reduce opioid use. One study developed recommendations for safely using cannabis with opioids, suggesting it can be a helpful addition to opioid tapering. Another study found that tapering opioids with support, including cannabis, led to improvements in how patients managed their pain and reduced problems related to opioid use. While other treatments like physiotherapy also show positive outcomes, the evidence for cannabis as part of opioid tapering is promising, especially in helping patients reduce their reliance on opioids.12345

What data supports the effectiveness of the treatment Medical Cannabis + Opioid Tapering for Chronic Pain?

Research suggests that using medical cannabis may help support opioid tapering and chronic pain control, as there are consensus-based recommendations on safely combining these treatments. Additionally, a study on opioid taper support showed improvements in pain management skills and reduced opioid-related problems, indicating potential benefits of such combined approaches.12345

What safety data exists for using medical cannabis with opioid tapering for chronic pain?

The safety data for using medical cannabis with opioid tapering for chronic pain is still emerging. A consensus-based recommendation study outlines how to safely initiate and titrate cannabinoids alongside opioids and how to taper opioids in the presence of cannabinoids, emphasizing patient monitoring and outcome evaluation. A randomized trial protocol aims to assess the effect of cannabis on opioid reduction and pain management. However, evidence supporting opioid tapering strategies, including the use of cannabis, is limited, and there are high drop-out rates in tapering programs. The complexity of persistent opioid dependence and the use of buprenorphine in tapering programs highlight the need for further research and policy development.13678

Is it safe to use medical cannabis with opioid tapering for chronic pain?

Research suggests that using medical cannabis to help reduce opioid use for chronic pain is being explored, but safety guidelines are still being developed. Experts are working on recommendations for safely starting and adjusting cannabis use while reducing opioids, and monitoring patients during this process.13678

Is the treatment Prescription Opioid Taper Support (POTS) promising for helping with chronic pain?

Yes, Prescription Opioid Taper Support (POTS) is promising for helping with chronic pain. It can help reduce the use of opioids, which are strong painkillers, and may work well when combined with other treatments like medical cannabis. This approach can help manage pain better and reduce the risk of problems related to opioid use.12368

How is the treatment Prescription Opioid Taper Support (POTS) unique for chronic pain management?

The Prescription Opioid Taper Support (POTS) treatment is unique because it combines medical cannabis with opioid tapering to manage chronic pain, aiming to reduce opioid use while controlling pain. This approach leverages the potential pain-relieving properties of cannabis to support the reduction of opioid doses, which is different from traditional methods that often rely solely on opioids or non-drug therapies.12368

What is the purpose of this trial?

This study will use a randomized controlled design to test whether medical marijuana use by adults on high-dose chronic opioid therapy (COT) for chronic non-cancer pain is associated with reduced opioid dose and improved pain intensity and interference when added to a 24-week behavioral intervention (POTS).

Research Team

JG

Jodi M Gilman, PhD

Principal Investigator

Massachusetts General Hospital

AE

A. Eden Evins, MD, MPH

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults aged 18-75 with chronic non-cancer pain, on stable opioid doses for over 90 days, who plan to use medical cannabis to manage pain or reduce opioids. Must not be heavy cannabis users, pregnant, or have severe health issues like cancer or major psychiatric disorders.

Inclusion Criteria

Potential participants of childbearing potential must have a negative urine pregnancy test at enrollment and agree to use effective contraception: abstinence; hormonal contraception; intra-uterine device, sterilization; or double barrier contraception, during the study
I plan to use medical cannabis for pain management or to lower my opioid use.
I plan to use medical cannabis for pain management or to lower my opioid use.
See 9 more

Exclusion Criteria

History of intellectual disability (e.g., Down's syndrome) or other severe developmental disorder or IQ < 70
My doctor thinks I can't safely follow the study's procedures.
Pregnant or trying to get pregnant or breastfeeding
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medical marijuana and participate in the POTS behavioral intervention for 24 weeks

24 weeks
Visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
1 visit at 12 months

Treatment Details

Interventions

  • Medical Marijuana
  • Prescription Opioid Taper Support (POTS)
Trial Overview The study is testing if medical marijuana plus a Prescription Opioid Taper Support program can help adults lower their opioid dosage and improve pain management compared to just the taper support program alone over a period of 24 weeks.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Medical Marijuana + Prescription Opioid Taper Support (POTS) behavioral treatmentExperimental Treatment2 Interventions
This group can begin using medical marijuana immediately and will participate in the POTS treatment groups.
Group II: Prescription Opioid Taper Support (POTS) treatment aloneActive Control1 Intervention
This group must abstain from marijuana use and will participate in the POTS behavioral treatment alone.

Prescription Opioid Taper Support (POTS) is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as Opioid Tapering Support for:
  • Chronic Non-Cancer Pain Management
  • Opioid Use Disorder Treatment
🇨🇦
Approved in Canada as Opioid Tapering Programs for:
  • Chronic Pain Management
  • Opioid Dependence Treatment
🇪🇺
Approved in European Union as Medication-Assisted Treatment for Opioid Use Disorder for:
  • Opioid Use Disorder Treatment
  • Chronic Pain Management

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Cambridge Health Alliance

Collaborator

Trials
65
Recruited
22,400+

MaineHealth

Collaborator

Trials
76
Recruited
43,800+

Findings from Research

Cannabinoids, particularly CBD-predominant extracts, can be considered for patients with chronic pain who are not achieving treatment goals with opioids, especially if they are experiencing opioid-related complications.
A consensus was reached on a safe approach to tapering opioids while introducing cannabinoids, recommending a gradual reduction of 5%-10% of the morphine equivalent dose every 1 to 4 weeks, alongside monitoring for improvements in function and pain reduction.
Consensus-based recommendations for titrating cannabinoids and tapering opioids for chronic pain control.Sihota, A., Smith, BK., Ahmed, SA., et al.[2021]
A scoping review of 39 articles found that rehabilitation interventions from physiotherapy and occupational therapy show positive outcomes in supporting opioid tapering for chronic pain, with 25 out of 28 studies reporting beneficial results.
Despite the promising findings, the evidence is limited, particularly regarding specific details of interventions, indicating a need for further research to establish effective strategies for opioid reduction in chronic pain management.
Role of Rehabilitation in Opioid Tapering: A Scoping Review.Wiens, M., Jarrett, D., Settimi, A., et al.[2023]
Chronic pain patients with prescription opioid use disorder (OUD) emphasized that a successful tapering process relies on personal motivation, perceived medical support, and effective pain coping strategies, highlighting the importance of a patient-centered approach.
Facilitators for completing an opioid tapering program included access to medical-assisted tapering, shared decision-making about the tapering pace, and comprehensive medical and psychological support, suggesting that these elements can significantly improve tapering outcomes.
Patients' perspectives on tapering programmes for prescription opioid use disorder: a qualitative study.Davies, LEM., Koster, ES., Damen, KF., et al.[2023]

References

Consensus-based recommendations for titrating cannabinoids and tapering opioids for chronic pain control. [2021]
Role of Rehabilitation in Opioid Tapering: A Scoping Review. [2023]
Patients' perspectives on tapering programmes for prescription opioid use disorder: a qualitative study. [2023]
Does Opioid Tapering in Chronic Pain Patients Result in Improved Pain or Same Pain vs Increased Pain at Taper Completion? A Structured Evidence-Based Systematic Review. [2020]
Prescription Opioid Taper Support for Outpatients With Chronic Pain: A Randomized Controlled Trial. [2019]
Randomised, pragmatic, waitlist controlled trial of cannabis added to prescription opioid support on opioid dose reduction and pain in adults with chronic non-cancer pain: study protocol. [2023]
Comparative Effectiveness of Opioid Tapering or Abrupt Discontinuation vs No Dosage Change for Opioid Overdose or Suicide for Patients Receiving Stable Long-term Opioid Therapy. [2022]
Complex Persistent Opioid Dependence with Long-term Opioids: a Gray Area That Needs Definition, Better Understanding, Treatment Guidance, and Policy Changes. [2021]
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