Pain Management Strategies for Opioid Use Disorder

Overseen By Rebecca K McHugh, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mclean Hospital

Must not be taking: Opioid analgesics

Disqualifiers: Psychiatric condition, Cardiovascular condition, others

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how individuals with opioid use disorder respond to pain and whether it influences their craving for opioids. Participants will be randomly assigned to one of two short education sessions: one focuses on changing pain interpretation (Pain De-Catastrophizing), and the other provides general pain education. This trial suits adults diagnosed with opioid use disorder who experience chronic pain and can read and give consent. As an unphased trial, it offers a unique opportunity to contribute to understanding pain management in opioid use disorder.

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.

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

Research has shown that pain de-catastrophizing is generally safe. This method involves a brief lesson on changing thoughts about pain and avoids medication, thus sidestepping common drug-related side effects.

Although specific data on negative effects is lacking, the educational focus suggests low risk. Previous studies have not identified safety concerns with this approach.

Overall, pain de-catastrophizing appears well-tolerated, offering a promising option for managing pain without drugs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they focus on altering how patients perceive and understand their pain, rather than relying on medications like opioids. Pain De-Catastrophizing aims to transform the way individuals interpret their pain, promoting a more positive and manageable outlook. This approach is different from standard treatments, which often involve pain-relieving drugs and therapy targeting physical symptoms. By reducing the emotional and psychological impact of pain, these strategies offer a promising alternative for managing pain in individuals with opioid use disorder.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that when people perceive their pain as worse than it is, they are more likely to misuse opioids. One study found that individuals who exaggerate their pain tend to use more opioids and experience worse emotional states. Another study discovered that high levels of this thinking can predict poor pain management and other health issues. This trial will compare two approaches: Pain De-Catastrophizing, which involves brief behavioral education on modifying the interpretation of pain, and Pain Education, which provides general education on pain. These findings suggest that changing how people think about their pain might improve their ability to manage it and reduce their cravings for opioids. ^{3 6 7 8 9}

Who Is on the Research Team?

Rebecca K McHugh, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

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

ability to read and provide informed consent

You have been diagnosed with addiction to opioids.

I suffer from long-term pain.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Pain De-Catastrophizing
• Pain Education

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.

How Is the Trial Designed?

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+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

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]

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]

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]

Opioids can be effective for managing chronic pain, supported by clinical trial and observational evidence, but their use must be carefully balanced against the risk of abuse and misuse.

A practical approach to prescribing opioids includes careful patient selection, risk assessment, individualized treatment plans, and ongoing monitoring, which can help enhance safety while still providing effective pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prescription opioid conundrum: 21st century solutions to a millennia-long problem. Brennan, MJ., Gudin, JA.[2020]

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 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 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]

Anesthesiologists play a crucial role in managing patients with opioid use disorder (OUD) during surgery by guiding evidence-based care and improving outcomes for these patients.

The article provides a comprehensive framework for anesthesiologists, covering treatment principles, perioperative considerations for patients on medication for OUD, and strategies for multimodal pain management, emphasizing the importance of non-opioid approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for Our Patients With Opioid Use Disorder in the Perioperative Period: A Guide for the Anesthesiologist. Barreveld, AM., Mendelson, A., Deiling, B., et al.[2023]

Chronic opioid therapy (COT) has not been proven safe or effective, with increasing evidence showing harmful effects such as addiction, respiratory depression, and even death.

Despite the risks, some patients on low doses of opioids for extended periods report effective pain control and maintain their daily functioning, suggesting a need to shift the focus from identifying those at risk of misuse to identifying those who may benefit from COT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who Benefits from Chronic Opioid Therapy? Rethinking the Question of Opioid Misuse Risk. Huber, E., Robinson, RC., Noe, CE., et al.[2022]

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]

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