Medical Cannabis + Opioid Tapering for Chronic Pain

Recruiting at 2 trial locations

Overseen By Jodi Gilman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Opioids

Must not be taking: Tricyclics, SSRIs, Gabapentin, NSAIDs

Disqualifiers: Substance use disorder, Cancer, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 24 weeks

87 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 3 6 7 8}

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. ^{1 2 3 6 8}

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. ^{1 2 3 6 8}

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

Jodi M Gilman, PhD

Principal Investigator

Massachusetts General Hospital

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.

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

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

Group I: Medical Marijuana + Prescription Opioid Taper Support (POTS) behavioral treatment Experimental Treatment 2 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 alone Active Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' perspectives on tapering programmes for prescription opioid use disorder: a qualitative study. Davies, LEM., Koster, ES., Damen, KF., et al.[2023]

A review of 20 studies involving 2,109 chronic pain patients indicated that 80% of the studies found that tapering opioids either improved pain or maintained the same pain level by the end of the taper, supporting the hypothesis that tapering does not increase pain.

Despite the positive findings, the studies were of lower quality (type 3 and 4) and lacked controlled designs, highlighting the need for more rigorous research to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Fishbain, DA., Pulikal, A.[2020]

A 22-week taper support intervention for patients on long-term opioid therapy showed a trend towards lower opioid doses compared to usual care, although the difference was not statistically significant.

Patients in the taper support group reported significantly greater improvements in pain interference, pain self-efficacy, and issues related to prescription opioids, suggesting that this intervention is feasible and beneficial for managing opioid tapering without increasing pain severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription Opioid Taper Support for Outpatients With Chronic Pain: A Randomized Controlled Trial. Sullivan, MD., Turner, JA., DiLodovico, C., et al.[2019]

This study will evaluate the effectiveness of cannabis in reducing opioid use and managing chronic non-cancer pain in 250 adults currently taking prescription opioids, as part of a comprehensive behavioral pain management program.

Participants will be randomly assigned to either use cannabis or abstain for 6 months, with primary outcomes focusing on changes in opioid dosage and pain interference, while also monitoring for any adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Jashinski, J., Grossman, E., Quaye, A., et al.[2023]

In a study of 199,836 individuals on long-term opioid therapy, tapering dosages resulted in a small increase in the risk of opioid overdose or suicide events compared to maintaining a stable dosage, with a risk difference of 0.15%.

The findings suggest that mandatory opioid tapering policies may not effectively reduce short-term risks of overdose and suicide for patients who are stable and show no signs of misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Larochelle, MR., Lodi, S., Yan, S., et al.[2022]

Long-term opioid therapy (LTOT) has been found to have limited efficacy for chronic pain, leading to increased tapering of opioids, which can cause complications like worsening pain and declining function.

The concept of complex persistent opioid dependence (CPOD) is emerging as a useful framework to understand the challenges associated with both ineffective LTOT and the complications of opioid tapering, highlighting the need for further research and policy development regarding its treatment, including the use of buprenorphine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex Persistent Opioid Dependence with Long-term Opioids: a Gray Area That Needs Definition, Better Understanding, Treatment Guidance, and Policy Changes. Manhapra, A., Sullivan, MD., Ballantyne, JC., et al.[2021]

References

1. India pubmed.ncbi.nlm.nih.gov

Consensus-based recommendations for titrating cannabinoids and tapering opioids for chronic pain control. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Role of Rehabilitation in Opioid Tapering: A Scoping Review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Patients' perspectives on tapering programmes for prescription opioid use disorder: a qualitative study. [2023]

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

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]

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

Prescription Opioid Taper Support for Outpatients With Chronic Pain: A Randomized Controlled Trial. [2019]

6. England pubmed.ncbi.nlm.nih.gov

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]

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

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]

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

Complex Persistent Opioid Dependence with Long-term Opioids: a Gray Area That Needs Definition, Better Understanding, Treatment Guidance, and Policy Changes. [2021]