Pain Management Strategies for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

Overseen by Rebecca K McHugh, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mclean Hospital

Must not be taking: Opioid analgesics

Disqualifiers: Psychiatric condition, Cardiovascular condition, others

Trial Summary

What is the purpose of this trial?

The goal of this study is to investigate the association between response to pain and opioid craving in people with opioid use disorder. In this study, adults with opioid use disorder will be randomized to one of two brief education sessions followed by an assessment of response to pain. Investigators will test the association between response to pain and opioid craving.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently receiving opioid medication for pain.

What data supports the effectiveness of the treatment Pain De-Catastrophizing and Pain Education for managing pain in patients with opioid use disorder?

Research shows that addressing pain catastrophizing (the tendency to view pain as unbearable) can improve outcomes for people with substance use disorders and chronic pain, suggesting that pain de-catastrophizing may help manage pain and improve psychological functioning in these patients. ^{1 2 3 4 5}

Is the treatment for pain management in opioid use disorder safe?

The research highlights the importance of using non-opioid pain management strategies and careful monitoring when managing pain in patients with opioid use disorder. These approaches are generally considered safe and support ongoing recovery. ^{1 6 7 8 9}

How does this treatment differ from other pain management strategies for opioid use disorder?

This treatment is unique because it involves continuing the usual medication-assisted therapy dose while using non-opioid and non-drug pain management strategies, and if necessary, immediate-release opioids, which are adjusted to the patient's needs. It emphasizes a collaborative approach with healthcare providers to ensure effective pain management without disrupting recovery from opioid use disorder. ^{1 2 6 10 11}

Research Team

Rebecca K McHugh, PhD

Principal Investigator

Mclean Hospital

Eligibility Criteria

This trial is for adults over 18 with chronic pain and diagnosed opioid use disorder who can read and consent to participate. It's not for those involuntarily in treatment, with recent heart issues, inflammatory/autoimmune diseases, on opioid pain meds, neuropathy, vasculitis, severe vascular disease or withdrawal.

Inclusion Criteria

I am 18 years old or older.

ability to read and provide informed consent

You have been diagnosed with addiction to opioids.

Exclusion Criteria

You have a severe mental or physical condition that would make it difficult for you to take part in the study.

I do not have severe nerve, blood vessel, or circulation problems.

I have an inflammatory or autoimmune disorder.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Education Session

Participants receive one of two brief education sessions on pain interpretation

1 day

1 visit (in-person)

Assessment

Assessment of response to pain and opioid craving using the Opioid Craving Scale

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any immediate effects post-intervention

1 week

Treatment Details

Interventions

• Pain De-Catastrophizing (Behavioral Intervention)
• Pain Education (Behavioral Intervention)

Trial Overview The study examines how education sessions about pain might influence the craving for opioids in individuals with an opioid use disorder. Participants will be randomly placed into one of two educational interventions and then assessed on their response to pain.

Participant Groups

Group I: Pain De-Catastrophizing Experimental Treatment 1 Intervention

Brief behavioral education on how to modify the interpretation of pain.

Group II: Pain Education Placebo Group 1 Intervention

Brief behavioral education on pain.

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

Dr. Susan M. Szulewski

Mclean Hospital

Chief Medical Officer since 2023

MD from University of Medical Sciences in Poznan, Poland; MBA from Heller School at Brandeis University

Dr. Scott L. Rauch

Mclean Hospital

Chief Executive Officer since 2006

MD from Harvard Medical School

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

Patients with opioid use disorder receiving medication-assisted therapy (like methadone or buprenorphine) may require careful pain management during acute care, especially for surgical procedures, due to the analgesic properties of these medications.

Effective pain management strategies include continuing the usual therapy dose, utilizing non-opioid pain relief methods, and closely monitoring for potential side effects, which can help support the patient's recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Pain Management for Patients Receiving Medication-Assisted Therapy. Compton, P.[2020]

Patients with opioid use disorders (OUDs) are particularly vulnerable during the perioperative phase, highlighting the need for careful management of acute pain and identification of OUDs during preoperative evaluations.

A multidisciplinary team approach is essential for effectively managing pain in patients with OUDs, ensuring balanced pain relief while supporting their recovery and treatment for opioid use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid Use Disorders: Perioperative Management of a Special Population. Ward, EN., Quaye, AN., Wilens, TE.[2023]

Introducing prescription opioids to opioid-naive patients after acute injuries can increase the risk of developing chronic opioid use, highlighting the need for alternative pain management strategies.

The case report emphasizes the importance of shared decision-making between patients and physicians to explore non-opioid therapies and address barriers to effective pain relief, especially for those with a history of opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I Just Don't Feel Heard": A Case Study on Opioid Use Disorder and Pain Management. Malik, A., Vu, PD., Cohen, AS., et al.[2023]

In a study of 244 patients with chronic pain undergoing substance use disorder treatment, higher levels of pain catastrophizing were linked to worse outcomes, including increased pain interference, cravings, anxiety, and mood difficulties.

Addressing pain catastrophizing in these patients could be a valuable strategy to enhance treatment outcomes for both chronic pain and substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between pain catastrophizing and clinical characteristics in adults with substance use disorders and co-occurring chronic pain. Kneeland, ET., Griffin, ML., Taghian, N., et al.[2020]

Shared Decision Making (SDM) is an important approach for improving patient engagement and satisfaction in acute pain management, especially for patients with a history of opioid use disorder (OUD), but its application in this context is still under-researched.

The review identified key themes affecting SDM in acute pain management for OUD patients, including stigma, the importance of trust and information sharing, the need for clinical tools, and the benefits of interprofessional collaboration, highlighting areas for future improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Decision Making in Acute Pain Management in Patients with Opioid Use Disorder: A Scoping Review. Vu, PD., Malik, A., Cohen, AS., et al.[2023]

Patients with opioid use disorder (OUD) expressed a strong preference for neuraxial blockade (like epidurals) for labor pain, but felt there were limited options for pain control and no consensus on using opioids, highlighting a need for more non-opioid alternatives.

Providers recognized the unique challenges in managing pain for patients with OUD and noted the need for better communication and collaboration among healthcare teams to improve pain management strategies during and after childbirth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstetric pain management for pregnant women with opioid use disorder: A qualitative and quantitative comparison of patient and provider perspectives (QUEST study). Nowakowski, E., Dayananda, S., Morgan, M., et al.[2023]

The CDC's 2022 guidelines encourage clinicians to carefully weigh the risks and benefits of continuing opioid therapy for chronic pain, highlighting the need for empathetic, patient-centered discussions to avoid patient abandonment.

The proposed harm-reductive framework aims to balance the risks of continuing versus discontinuing opioid therapy, fostering trust between patients and providers and promoting evidence-based, multi-modal pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harms Versus Harms: Rethinking Treatment for Patients on Long-Term Opioids. Lagisetty, P., Kertesz, S.[2023]

This case report highlights that effective pain management is achievable for patients with opioid use disorder (OUD) on extended-release buprenorphine (ER-buprenorphine) through individualized, multidisciplinary approaches, as demonstrated in three different clinical scenarios.

Strategies for managing acute pain in these patients can include supplemental sublingual buprenorphine, non-opioid medications, and short-term use of full opioid agonists, while addressing barriers such as provider bias and access to specialized care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain Management in Patients With Opioid Use Disorder on Extended-release Buprenorphine: A Case Report. South, AM., Oller, D., Lofwall, M., et al.[2023]

References

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

Acute Pain Management for Patients Receiving Medication-Assisted Therapy. [2020]

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

Opioid Use Disorders: Perioperative Management of a Special Population. [2023]

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

"I Just Don't Feel Heard": A Case Study on Opioid Use Disorder and Pain Management. [2023]

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

Associations between pain catastrophizing and clinical characteristics in adults with substance use disorders and co-occurring chronic pain. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Shared Decision Making in Acute Pain Management in Patients with Opioid Use Disorder: A Scoping Review. [2023]

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

Obstetric pain management for pregnant women with opioid use disorder: A qualitative and quantitative comparison of patient and provider perspectives (QUEST study). [2023]

7. England pubmed.ncbi.nlm.nih.gov

The prescription opioid conundrum: 21st century solutions to a millennia-long problem. [2020]

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

Harms Versus Harms: Rethinking Treatment for Patients on Long-Term Opioids. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Who Benefits from Chronic Opioid Therapy? Rethinking the Question of Opioid Misuse Risk. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Pain Management in Patients With Opioid Use Disorder on Extended-release Buprenorphine: A Case Report. [2023]

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

Caring for Our Patients With Opioid Use Disorder in the Perioperative Period: A Guide for the Anesthesiologist. [2023]