Stepped Care for Opioid Use Disorder and Chronic Pain

(SC-POWR Trial)

Recruiting at 1 trial location

Overseen By Svetlana Vassilieva

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must be taking: MOUD

Disqualifiers: Pending surgery, Psychiatric instability, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare a new treatment approach called SC-POWR with standard care for individuals with opioid use disorder and chronic pain. SC-POWR combines cognitive behavioral therapy, medication, and activities like exercise and stress reduction to help reduce pain and improve overall well-being. The trial seeks participants who have experienced chronic pain for over three months and are currently using medication to treat opioid use disorder. Researchers will follow participants for nearly a year to evaluate the treatment's effectiveness in reducing pain, anxiety, and substance use. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you will begin medications for opioid use disorder as part of the study.

What prior data suggests that SC-POWR is safe for patients with opioid use disorder and chronic pain?

Research has shown that SC-POWR, a program combining talk therapy, medication for opioid addiction, exercise, and stress relief, is generally manageable for participants. In similar past studies, individuals with opioid addiction and long-term pain participated without major safety issues.

The program includes activities like Wii Fit, Tai Chi, and relaxation exercises, which are typically safe and have few side effects. Ear acupuncture is also considered low-risk. While any treatment can have some side effects, no strong evidence of serious problems has emerged in the studied groups.

Overall, SC-POWR aims to aid recovery by focusing on both physical and mental health, enhancing life quality for those with opioid addiction and chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

SC-POWR is unique because it combines traditional treatment for opioid use disorder with cognitive behavioral therapy (CBT) and potentially steps up to include exercise and stress reduction techniques. Unlike standard treatments, which often focus solely on medication-assisted therapy using options like methadone or buprenorphine, SC-POWR integrates mental and physical wellness strategies. Researchers are excited about this approach because it addresses both the psychological and physical aspects of opioid use disorder and chronic pain, potentially leading to more comprehensive and lasting recovery outcomes.

What evidence suggests that SC-POWR could be an effective treatment for opioid use disorder and chronic pain?

Research has shown that the Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) program, which participants in this trial may receive, can assist individuals with both opioid use disorder (OUD) and chronic pain (CP). In studies involving patients with these conditions, SC-POWR, which includes talk therapy, medications for OUD, and activities like exercise and stress relief, proved effective. It reduced the use of illegal opioids and lessened pain's impact on daily life. The program also aims to enhance overall well-being by reducing anxiety, depression, and stress, and by improving sleep quality. This treatment approach addresses multiple challenges these patients face, offering a comprehensive option for those struggling with OUD and CP. ^{1 3 4 6 7}

Who Is on the Research Team?

Declan Barry

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with opioid use disorder and chronic pain that disrupts daily life. They must be seeking treatment, understand English, consent to participate, and have been on medications for opioid use disorder for less than a year. Excluded are those planning surgeries or moves, experiencing acute psychosis or suicidal thoughts, or unable to exercise due to health reasons.

Inclusion Criteria

Seeking treatment at APT Foundation

I am currently receiving medication for opioid addiction.

Current APT MOUD episode is 12 months or less

Exclusion Criteria

Acutely psychotic, suicidal, or homicidal

Has a contraindication to exercise (e.g. complete heart block)

Has a pending or planned relocation or pending incarceration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either treatment as usual or SC-POWR, which includes MOUD, CBT, and onsite groups for exercise and stress reduction for 24 weeks

24 weeks

Weekly visits

Follow-up

Participants are monitored for durability of treatment response, including illicit opioid use, alcohol use, pain interference, anxiety, depression, stress, sleep, and retention in MOUD

24 weeks

Monthly visits

Peer-support extension

Following 24 weeks of SC-POWR, patients are offered once monthly peer-support groups

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

• SC-POWR

Trial Overview The study compares usual treatment with SC-POWR—a combination of cognitive behavioral therapy (CBT), medication-assisted treatment (MOUD), and group activities like Wii Fit, Tai Chi, relaxation training, and auricular acupuncture—over a period of 24 weeks followed by another 24-week evaluation phase.

How Is the Trial Designed?

Group I: SC-POWR Experimental Treatment 1 Intervention

Treatment as usual for opioid use disorder with the addition of CBT with possible stepped care to exercise and stress reduction

Group II: Treatment as Usual Active Control 1 Intervention

Treatment as usual for opioid use disorder

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The EMPOWER study is addressing the urgent need for safe and effective strategies for tapering opioids in chronic pain patients, as current methods have high dropout rates and can increase patient distress.

A new consensus screening tool has been developed to help clinicians identify Opioid Use Disorder (OUD) and assess its severity, which is crucial for determining appropriate treatment pathways for patients on long-term opioid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Screening Tool for Opioid Use Disorder: EMPOWER Study Expert Consensus Protocol. You, DS., Mardian, AS., Darnall, BD., et al.[2021]

In 2019, only 18.8% of substance use treatment facilities (out of 15,945 surveyed) offered specialized programs for patients with both chronic pain and substance use disorders, highlighting a significant gap in available treatment options.

Facilities that provided tailored programs were more likely to serve veterans, focus on clients with opioid use disorder, and offer maintenance treatments like methadone or buprenorphine, indicating specific characteristics that may enhance the availability of integrated care for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With the Presence of Co-occurring Pain and Substance Use Disorder Programs in Substance Use Treatment Facilities. Ramdin, C., Attaalla, K., Ghafoor, N., et al.[2023]

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]

California's Hub and Spoke model aims to improve access to buprenorphine for opioid use disorder by connecting treatment programs (hubs) with primary care and other healthcare settings (spokes), potentially reducing overdose deaths.

The implementation plan includes extensive training and support for healthcare providers to increase the number of prescribers and enhance their skills, which is crucial for effectively addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the hub and spoke model for opioid use disorders in California: Rationale, design and anticipated impact. Miele, GM., Caton, L., Freese, TE., et al.[2021]

The study evaluates the effectiveness of the Substance Use Treatment and Recovery Team (START) in increasing the initiation of FDA-approved medications for opioid use disorder during hospital stays, compared to usual care, across three academic hospitals.

By focusing on linking patients to outpatient treatment after discharge, the START intervention aims to improve long-term outcomes for individuals with opioid use disorder, addressing a critical gap in care during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Substance Use Treatment and Recovery Team (START) study: protocol for a multi-site randomized controlled trial evaluating an intervention to improve initiation of medication and linkage to post-discharge care for hospitalized patients with opioid use disorder. Ober, AJ., Murray-Krezan, C., Page, K., et al.[2023]

A new 10-item questionnaire called the CAP-POD was developed to assess primary care providers' (PCPs) capacity to treat patients with both chronic pain and opioid use disorder (OUD), demonstrating good reliability and initial validity based on a study of 509 PCPs.

The results indicated that while PCPs felt confident in their understanding of best practices and risk assessment, they reported low motivation to treat this patient population and perceived inadequate access to necessary services, suggesting areas for targeted improvement in care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of the Capacity to Treat Chronic Pain and Opioid Use Disorder (CAP-POD) questionnaire. Varley, AL., Goodin, BR., Copes, H., et al.[2023]

Stepped care models have shown feasibility and efficacy in managing chronic pain (CP) and opioid use disorder (OUD) in primary care settings, although studies primarily focused on patients at risk rather than those with existing OUD.

There is a significant lack of treatment options for individuals suffering from both chronic pain and opioid use disorder, highlighting the need for further research and improved access to integrated pain and substance use programs for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comorbid chronic pain and opioid use disorder: literature review and potential treatment innovations. Speed, TJ., Parekh, V., Coe, W., et al.[2019]

An integrative, collaborative care model involving a Provider, Physical Therapist, and Patient was successfully implemented in a multidisciplinary HIV/AIDS clinic, showing feasibility in clinic workflow and acceptability among participants.

The case study demonstrated that this approach led to the complete elimination of the patient's chronic pain and cessation of all opioid use, suggesting a promising alternative to traditional opioid tapering methods that often neglect chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Silos to Solidarity: Case Study of a Patient-Centered, Integrative Approach to Opioid Tapering and Chronic Pain Mitigation in a Multidisciplinary AIDS Clinic. Pullen, S., Marconi, VC., Del Rio, C., et al.[2022]

A review identified seven quality measures for treating opioid use disorder (OUD), all of which focus on the processes of service delivery, highlighting the need for better assessment of treatment outcomes and patient experiences.

There is a significant gap in quality measures specifically tailored for OUD, indicating that a unified framework, like an OUD Treatment Cascade, is necessary to improve care access and reduce opioid-related deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an opioid use disorder treatment cascade: A review of quality measures. Williams, AR., Nunes, EV., Bisaga, A., et al.[2022]

A novel integrated care model for patients with opioid use disorder (OUD) and severe injection-related infections (SIRI) allows for the combination of addiction treatment and outpatient parenteral antimicrobial therapy (OPAT), which is typically not offered to these patients due to concerns about their drug use.

This pilot study highlights the potential for improved management of OUD and SIRI by providing buprenorphine induction during hospitalization and continuing care in an outpatient setting, suggesting a promising approach to address both addiction and infection treatment simultaneously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated outpatient treatment of opioid use disorder and injection-related infections: A description of a new care model. Fanucchi, LC., Walsh, SL., Thornton, AC., et al.[2020]

In a study of 322 patients hospitalized for infectious complications from injecting opioids, those who received medication for opioid use disorder (MOUD) during their hospital stay had significantly better outcomes, including higher odds of planned discharge and being linked to outpatient MOUD after discharge.

Despite the benefits of MOUD, there was a concerning level of undertreatment, with only 45% receiving MOUD during hospitalization and high rates of premature discharge (20%) and readmission (50%), indicating a need for improved addiction care strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undertreatment of opioid use disorder in patients hospitalized with injection drug use-associated infections. Rosenthal, ES., Brokus, C., Sun, J., et al.[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]

The EMPOWER study is a comprehensive, multi-state, randomized controlled trial designed to help patients with chronic pain safely reduce long-term opioid use through three different approaches: cognitive behavioral therapy, self-management, and usual care.

By collecting detailed patient-reported data and using real-time feedback, the study aims to provide valuable insights into the effectiveness of these methods for opioid tapering, ultimately improving patient outcomes and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol. Darnall, BD., Mackey, SC., Lorig, K., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38606900/

Stepped Care for Patients to Optimize Whole Recovery (SC ... A randomized clinical trial of 316 patients with OUD and CP to test the effectiveness of TAU compared with Stepped Care for Patients to Optimize Whole Recovery ...

2. awspntest.apa.org awspntest.apa.org/doi/10.1177/29767342241245095

Stepped Care for Patients to Optimize Whole Recovery (SC ... The estimated rates of chronic pain (CP) among patients on medications for opioid use disorder (MOUD) are higher than the general population (37%-61% vs 20%) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05155163?tab=table

Stepped Care for Patients to Optimize Whole Recovery ... Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) ... The composite outcome will take into account reductions in both illicit opioid use and pain ...

4. researchgate.net researchgate.net/publication/379782564_Stepped_Care_for_Patients_to_Optimize_Whole_Recovery_SC-POWR_An_Effectiveness_Trial_Evaluating_a_Stepped_Care_Model_for_Individuals_With_Opioid_Use_Disorder_and_Chronic_Pain

Stepped Care for Patients to Optimize Whole Recovery (SC ... The Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) trial demonstrated effectiveness of integrated pain management in OUD, 33 while web-based ...

5. withpower.com withpower.com/trial/phase-chronic-pain-11-2021-09571

Stepped Care for Opioid Use Disorder and Chronic Pain The SC-POWR medical study, being run by Yale University, is evaluating whether SC-POWR will have tolerable side effects & efficacy for patients with Chronic ...

6. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/29767342241245095

Stepped Care for Patients to Optimize Whole Recovery (SC ... Based on prespecified nonresponse criteria, SC-POWR may be stepped up at week 6 to receive onsite weekly group sessions of exercise (Wii Fit, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12051982/

Addressing the Intersections of Chronic Pain and OUD While this program emphasizes CP and OUD/opioid misuse as the primary outcomes, the second goal of the network is to attend to the whole patient for whom ...