Pain Self-Management for Opioid Use Disorder

(TREETOP Trial)

Recruiting at 15 trial locations

Overseen By Melessa Salay, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Buprenorphine, Methadone, Naltrexone

Disqualifiers: Under 18, Cancer-related pain, others

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

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Pain Self-Management (PSM), delivered through phone or online sessions, can assist individuals with chronic pain who also face opioid misuse or opioid use disorder (OUD). The primary focus is whether PSM can improve pain management and encourage participation in opioid treatment. Participants will either join the PSM program or continue with their usual care for 12 weeks and complete surveys over nine months. Ideal participants are those experiencing bothersome or high-impact chronic pain and have been identified as having opioid misuse or OUD. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance chronic pain management strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on certain opioid treatments like buprenorphine, methadone, or naltrexone for more than 7 days in the past 90 days, you cannot participate.

What prior data suggests that Pain Self-Management is safe for individuals with opioid use disorder?

Research shows that Pain Self-Management (PSM) is generally easy for participants to handle. Participants in similar programs have reported better pain management without major side effects. Studies have found that group-based PSM programs often lead to reduced opioid misuse, suggesting benefits for both pain and opioid use.

No specific negative effects have been reported for PSM itself. However, discussing personal topics in any study can sometimes cause emotional discomfort. It's important to weigh these risks against the potential benefits when deciding whether to participate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Pain Self-Management (PSM) for opioid use disorder because it offers a new approach to managing chronic pain without relying on medications. Unlike traditional treatments that often depend on opioids or other pharmacological interventions, PSM is a behavioral intervention delivered through phone or web-based sessions. This method empowers patients to manage their pain through tailored strategies, reducing the risk of opioid misuse. By focusing on self-management techniques, PSM has the potential to provide effective pain relief while minimizing dependence on opioids, which is a significant advancement in treating opioid use disorder.

What evidence suggests that Pain Self-Management might be an effective treatment for opioid use disorder?

Research has shown that Pain Self-Management (PSM), which participants in this trial may receive, can help individuals with long-term pain and opioid use disorder (OUD) feel better and use fewer opioids. Studies have found that participating in online pain self-management programs can lead to less pain and reduced opioid misuse. Participants in these programs also reported feeling less depressed and noted that pain interfered less with their daily activities. Additionally, some studies found that PSM can help reduce the amount of opioids needed for pain relief. Overall, evidence suggests that PSM could be a useful tool for managing chronic pain and reducing opioid use. ^{2 4 6 7 8}

Who Is on the Research Team?

Erin Winstanley, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals with chronic pain who also misuse opioids or have an opioid use disorder. They should be willing to engage in a Pain Self-Management program or receive standard care and complete surveys over 9 months.

Inclusion Criteria

Access to phone and/or internet

Current or new primary care patient at a participating clinic

Must meet criteria for OUD or opioid misuse based on specific criteria

Exclusion Criteria

I experience pain due to my cancer.

Currently in jail, prison, overnight/residential facility as required by court of law or have pending legal action

Had an intentional suicide attempt within the past 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take part in the Pain Self-Management (PSM) program or receive standard care for 12 weeks

12 weeks

10 sessions (phone or web-based)

Follow-up

Participants complete surveys every 3 months for 9 months to monitor engagement and pain management

9 months

4 visits (survey completion)

What Are the Treatments Tested in This Trial?

Interventions

• Pain Self-Management

Trial Overview The study tests if Pain Self-Management (PSM) can better manage chronic pain and improve treatment engagement compared to usual care for those with opioid misuse issues. Participants will follow the assigned intervention for 12 weeks.

How Is the Trial Designed?

Group I: Pain Self-Management (PSM) Experimental Treatment 1 Intervention

PSM is a manualized pain self-management behavioral intervention tailored to patients with chronic pain and opioid misuse/OUD. PSM consists of 10 intervention sessions delivered via phone or web-based communication platform. Sessions will be led by a staff interventionist.

Group II: Usual Care Active Control 1 Intervention

Usual care refers to the standard of care that patients receive at their primary care clinic.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a pilot study involving 60 adults with chronic pain and opioid use disorder, participants who used an online pain self-management program reported significant reductions in pain interference, pain severity, opioid misuse, and depressive symptoms after 8 weeks.

The study highlights that a majority of participants initially used opioids due to pain, indicating that effective pain management strategies like this online program could be crucial in addressing both pain and opioid misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in online pain self-management improves pain in adults on medication-assisted behavioral treatment for opioid use disorders. Wilson, M., Finlay, M., Orr, M., et al.[2019]

A web-based self-management intervention for chronic pain patients on opioids was developed based on feedback from 53 participants, highlighting the need for additional pain management strategies and the importance of goal setting.

Participants found the web-based tool potentially useful and acceptable, indicating that it effectively increased their knowledge about self-management of chronic pain, suggesting a promising approach for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. Moore, SK., Guarino, H., Acosta, MC., et al.[2022]

In a study of 119 patients using opioids for chronic pain, most participants reported low levels of readiness (average 2.6) and self-efficacy (average 3.8) to reduce or stop opioid use, indicating a need for targeted interventions.

Factors such as lower pain severity and higher concerns about opioids were associated with greater readiness to change, while shorter pain duration predicted higher self-efficacy, suggesting these patients may be more open to opioid tapering and discontinuation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Motivation to Reduce or Discontinue Opioids for Chronic Pain: Self-efficacy, Barriers, and Readiness to Change. Crouch, TB., Donovan, E., Smith, WR., et al.[2023]

Patients with substance use disorders (SUDs) should be routinely assessed for their condition to ensure effective pain management strategies are implemented.

An interdisciplinary approach is crucial for managing pain in patients with SUDs, highlighting the important role of oncology nurses in screening and monitoring these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing Cancer Pain in Patients with Opioid and Substance Use Disorders. Edwards, T., Foster, T., Brant, JM.[2020]

Pain and substance abuse often occur together, complicating treatment for both conditions, which highlights the importance of understanding their interrelationship for effective management.

The article provides practical guidelines for safely using opioids to treat pain in patients with a history of addiction, emphasizing that all pain complaints should be thoroughly investigated to ensure effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges in using opioids to treat pain in persons with substance use disorders. Savage, SR., Kirsh, KL., Passik, SD.[2021]

Chronic pain patients with psychiatric comorbidities, particularly depression and anxiety disorders, are at a higher risk of developing problematic opioid use, as shown by longitudinal studies.

The review suggests that psychiatric screening should be integrated into chronic pain management to monitor and address the risks of opioid use disorders in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iatrogenic opioid use disorder, chronic pain and psychiatric comorbidity: A systematic review. van Rijswijk, SM., van Beek, MHCT., Schoof, GM., et al.[2020]

A web-based self-management intervention based on cognitive behavior therapy significantly reduced aberrant drug-related behavior and pain catastrophizing in chronic pain patients at risk for opioid misuse, compared to standard treatment alone, in a study of 110 participants over 12 weeks.

The intervention also led to fewer pain-related emergency department visits, indicating its potential effectiveness in improving the management of chronic pain and reducing risky behaviors associated with opioid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Cognitive Behavior Therapy for Chronic Pain Patients with Aberrant Drug-Related Behavior: Outcomes from a Randomized Controlled Trial. Guarino, H., Fong, C., Marsch, LA., et al.[2023]

16% of hospital admissions for opioid-related conditions resulted in self-directed discharges, which is over five times higher than the general population, highlighting a significant risk factor for poor health outcomes.

Patients with acute pain diagnoses were nearly twice as likely to self-discharge, indicating that inadequate pain management may contribute to this behavior, emphasizing the need for effective pain care in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute pain and self-directed discharge among hospitalized patients with opioid-related diagnoses: a cohort study. Compton, P., Aronowitz, SV., Klusaritz, H., et al.[2022]

Chronic pain is reported by 33.4% of individuals entering opioid use disorder (OUD) treatment programs, but 66% of those with chronic pain do not have their pain managed within these programs, leading to worsening pain for 47% of them.

The lack of effective pain management in OUD treatment is linked to a higher risk of opioid relapse, highlighting the need for interdisciplinary care and evidence-based policies to improve pain management and treatment outcomes for OUD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Chronic Pain Management in the Treatment of Opioid Use Disorder: Gaps in Care and Implications for Treatment Outcomes. Ellis, MS., Kasper, Z., Cicero, T.[2021]

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]

Opioid analgesics can be effective for severe chronic pain, but they carry significant risks such as misuse, addiction, and overdose, particularly in patients with certain risk factors like past substance abuse or untreated psychiatric disorders.

Proper candidate selection, thorough assessment, and ongoing monitoring are crucial for safe opioid therapy, as the prevalence of opioid-related mortality is notably higher in middle-aged individuals with substance abuse issues and psychiatric comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors for Opioid-Use Disorder and Overdose. Webster, LR.[2018]

A study involving 44 patients with chronic pain and substance abuse disorders showed significant improvements in pain management, emotional distress, and medication use after a 10-week outpatient treatment program.

At the 12-month follow-up, half of the participants were opioid-free, indicating that an integrated treatment model can effectively address both pain and substance use issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome from integrated pain management treatment for recovering substance abusers. Currie, SR., Hodgins, DC., Crabtree, A., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06855732

Pain Self-Management and Treatment Engagement for ... The goal of this study is to learn if Pain Self-Management (PSM) can improve chronic pain care in individuals with opioid misuse or opioid use disorder ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10014474/

Opioid dose and pain effects of an online pain self- ... Online pain self-management can augment usual care for adults with chronic pain. Benefits include opioid dose reductions that coincide with improved pain ...

3. withpower.com withpower.com/trial/phase-chronic-pain-10-2024-64afc

Pain Self-Management for Opioid Use Disorder The goal of this study is to learn if Pain Self-Management (PSM) can improve chronic pain care in individuals with opioid misuse or opioid use disorder ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2805141

Reducing Opioid Use for Chronic Pain With a Group-Based ... This randomized clinical trial compares the efficacy of a multicomponent, group-based, self-management intervention vs usual care in reducing opioid use.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460318303642

Engagement in online pain self-management improves ... Those who engaged in the online program had significantly lower pain interference, pain severity, opioid misuse measures, and depressive symptoms after eight ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK458655/

Pain Management and the Opioid Epidemic - NCBI Bookshelf A study of 1,477 adults prescribed opioids for chronic pain, for example, showed that patients who used lower or intermittent doses of opioids had pain outcomes ...

7. va.gov va.gov/painmanagement/opioid_safety_initiative_osi.asp

Pain Management, Opioid Safety, and PDMP (PMOP) Data presented includes key variables that influence patient risk, such as PTSD, Substance Use Disorder (SUD) and Obstructive Sleep Apnea (OSA) ...

8. academic.oup.com academic.oup.com/painmedicine/article/21/9/1977/5757957

Impact on Pain-Related Outcomes and Opioid Misuse in ... Our findings suggest reduced opioid misuse among IPT patients as measured by the COMM. Specifically, patients reported fewer arguments and ...