Medical Cannabis + Opioid Tapering for Chronic Pain

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Jodi M Gilman, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

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).

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.

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 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 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}

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

Treatment Details

Interventions

• Medical Marijuana (Cannabinoid)
• Prescription Opioid Taper Support (POTS) (Behavioural Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cambridge Health Alliance Cambridge, MA

Maine Medical Center Portland, ME

Massachusetts General Hospital Boston, MA

Who Is Running the Clinical Trial?

Massachusetts General Hospital Lead Sponsor

National Institute on Drug Abuse (NIDA) Collaborator

Cambridge Health Alliance Collaborator

MaineHealth Collaborator

References

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

Consensus-based recommendations for titrating cannabinoids and tapering opioids for chronic pain control. [2021] Opioid misuse and overuse have contributed to a widespread overdose crisis and many patients and physicians are considering medical cannabis to support opioid tapering and chronic pain control. Using a five-step modified Delphi process, we aimed to develop consensus-based recommendations on: 1) when and how to safely initiate and titrate cannabinoids in the presence of opioids, 2) when and how to safely taper opioids in the presence of cannabinoids and 3) how to monitor patients and evaluate outcomes when treating with opioids and cannabinoids.

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

Role of Rehabilitation in Opioid Tapering: A Scoping Review. [2023] Purpose: Among industrialized countries, Canada has the second-highest opioid prescribing rate for pain management. Physiotherapy and occupational therapy interventions are potential non-pharmacological alternatives. We undertook a scoping review to explore and summarize the current evidence describing the interventions included or used in physiotherapy and occupational therapy in opioid tapering for individuals with chronic pain. Method: A systematic search of the peer-reviewed health databases was conducted, with data synthesis guided by Arksey and O'Malley's scoping review methodology. Articles were included in the narrative synthesis if (1) interventions within the scope of practice for physiotherapists or occupational therapists were described or these professionals were part of interdisciplinary care and (2) opioid tapering or reduction was addressed. Results: The 39 articles identified included 2 systematic reviews, 9 narrative reviews or commentaries, 2 case reports, 11 uncontrolled cohort studies, 1 cross-sectional study, 5 randomized controlled trials, 4 programme evaluations, and 4 qualitative studies. Of the 28 studies reporting specific outcomes, 25 reported positive outcomes of rehabilitation interventions for opioid tapering. There was greater representation of interventions from physiotherapy than from occupational therapy: few articles contained substantive descriptions (e.g., dosage and duration). Conclusions: The evidence to guide therapists in supporting opioid tapering for people with chronic pain seems to be limited. Further research is needed to establish effectiveness for stand-alone interventions and as part of a comprehensive rehabilitation approach.

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

Patients' perspectives on tapering programmes for prescription opioid use disorder: a qualitative study. [2023] Approximately 10% of chronic pain patients who receive opioids develop an opioid use disorder (OUD). Tapering programmes for these patients show high drop-out rates. Insight into chronic pain patients' experiences with tapering programmes for prescription OUD could help improve such programmes. Therefore, we investigated the perspectives of chronic pain patients with prescription OUD to identify facilitators and barriers to initiate and complete a specialised OUD tapering programme.

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] To support or refute the hypothesis that opioid tapering in chronic pain patients (CPPs) improves pain or maintains the same pain level by taper completion but does not increase pain.

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

Prescription Opioid Taper Support for Outpatients With Chronic Pain: A Randomized Controlled Trial. [2019] Patients receiving long-term opioid therapy for chronic pain and interested in tapering their opioid dose were randomly assigned to a 22-week taper support intervention (psychiatric consultation, opioid dose tapering, and 18 weekly meetings with a physician assistant to explore motivation for tapering and learn pain self-management skills) or usual care (N = 35). Assessments were conducted at baseline and 22 and 34 weeks after randomization. Using an intention to treat approach, we constructed linear regression models to compare groups at each follow-up. At 22 weeks, adjusted mean daily morphine-equivalent opioid dose in the past week (primary outcome) was lower in the taper support group, but this difference was not statistically significant (adjusted mean difference = -42.9 mg; 95% confidence interval, -92.42 to 6.62; P = .09). Pain severity ratings (0-10 numeric rating scale) decreased in both groups at 22 weeks, with no significant difference between groups (adjusted mean difference = -.68; 95% confidence interval, -2.01 to .64; P = .30). The taper support group improved significantly more than the usual care group in self-reported pain interference, pain self-efficacy, and prescription opioid problems at 22 weeks (all P-values

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] Chronic, non-cancer pain impacts approximately 50 million adults in the USA (20%), approximately 25% of whom receive chronic prescription opioids for pain despite limited empirical efficacy data and strong dose-related risk for opioid use disorder and opioid overdose. Also despite lack of efficacy data, there are many reports of people using cannabis products to manage chronic pain and replace or reduce chronic opioids. Here we describe the protocol for a randomised trial of the effect of cannabis, when added to a behavioural pain management and prescription opioid taper support programme, on opioid utilisation, pain intensity and pain interference.

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] Opioid dosage tapering has emerged as a strategy to reduce harms associated with long-term opioid therapy; however, evidence supporting this approach is limited.

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] The multitude of treatments available for tens of millions of US adults with moderate/severe chronic pain have limited efficacy. Long-term opioid therapy (LTOT) is a widely available option for controlling pain among patients with chronic pain refractory to other treatments. The recent recognition of LTOT inefficacy and complications has led to more frequent opioid tapering, which in turn has revealed its own set of complications. The occurrence of the same set of symptoms-worsening pain, declining function, and clinical instability-in contrasting contexts of LTOT ineffectiveness and opioid tapering has led to increasing recognition of the utility of complex persistent opioid dependence (CPOD), a clinically distinct but biologically similar state compared with opioid use disorder as an explanatory diagnosis/heuristic. Recent guidelines for LTOT tapering have incorporated buprenorphine treatment based on CPOD concepts as a recommended treatment for problems due to opioid tapering with limited supportive evidence. The increasing utilization of buprenorphine for both LTOT ineffectiveness and opioid tapering problems raises the urgent need for a review of the clinical definition, mechanisms, and treatment of CPOD and pertinent policies. In this manuscript, we discuss various issues related to CPOD that requires further clarification through research and policy development.