Medical Cannabis + Opioid Tapering for Chronic Pain

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if medical cannabis can help adults on high-dose opioid therapy for chronic pain reduce opioid use and improve pain management. Participants will either use medical cannabis with a behavioral support program or participate in the support program without cannabis. It suits individuals with chronic, non-cancer pain for over six months who are on a stable opioid prescription and considering medical cannabis for pain management or opioid reduction. As an unphased trial, this study provides a unique opportunity to explore alternative pain management strategies.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that medical marijuana might help manage pain, but safety concerns exist. Some studies found that people using medical cannabis for a year experienced more side effects than those who did not use it. These side effects can range from mild to serious. However, other research indicates that medical cannabis can reduce pain and improve the quality of life for people with long-term pain.

While medical marijuana appears promising for pain relief, awareness of possible side effects is important. Prospective participants in a trial involving medical cannabis should understand both the potential benefits and risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores how medical cannabis can assist in tapering off opioids for chronic pain management. Unlike traditional treatments that rely solely on prescription opioids, this approach integrates medical marijuana, which might offer pain relief with potentially fewer side effects and lower risk of addiction. By incorporating cannabis into the opioid tapering process, there is hope for enhanced pain management and reduced opioid dependency, paving the way for safer, more effective chronic pain treatment options.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Studies have shown that medical marijuana can help reduce chronic pain. One study found it more effective than some prescription drugs in easing pain after just three months. Another report noted that many patients using medical cannabis experienced a significant drop in pain levels. Additionally, about a third of people with chronic pain have reported using cannabis to improve their quality of life. In this trial, one group will receive medical marijuana alongside Prescription Opioid Taper Support (POTS), while another group will receive only POTS treatment. These findings suggest that medical marijuana could help manage chronic pain when combined with other treatments. ^{3 6 7 8 9}

Who Is on the Research Team?

Jodi M Gilman, PhD

Principal Investigator

Massachusetts General Hospital

A. Eden Evins, MD, MPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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

I plan to use medical cannabis for pain management or to lower my opioid use.

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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