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 is a prospective, randomized clinical trial of 204 patients with opioid use disorder (OUD) and chronic pain (CP) to test the effectiveness of treatment as usual compared with Stepped Care for Patients to Optimize Whole Recovery (SC-POWR) to reduce pain interference (Aim 1) and decrease illicit opioid use, alcohol use, anxiety, depression, and stress, and improve sleep (Aim 2). Eligible participants will begin medications for opioid use disorder (MOUD) and will be randomized to receive SC-POWR (i.e., cognitive behavioral therapy (CBT), MOUD, and onsite groups for exercise \[Wii Fit, Tai Chi\] and stress reduction \[relaxation training, auricular acupuncture\] for 24 weeks. Participants will be followed for another 24 weeks to evaluate durability of treatment response on pain interference illicit opioid use, alcohol use, anxiety, depression, stress, sleep, and retention in MOUD (Aim 3).

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.

Is the Stepped Care for Opioid Use Disorder and Chronic Pain treatment safe for humans?

The available research highlights the need for safe opioid tapering strategies to prevent potential harms like increased pain or distress, but it does not provide specific safety data for the Stepped Care treatment itself. ^{1 2 3 4 5}

What makes the SC-POWR treatment unique for opioid use disorder and chronic pain?

SC-POWR is unique because it uses a stepped care model, which means it provides different levels of treatment based on the patient's needs, integrating both chronic pain management and opioid use disorder care. This approach contrasts with traditional treatments that often focus only on opioid addiction without addressing chronic pain, which can lead to better overall outcomes for patients. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment SC-POWR for opioid use disorder and chronic pain?

The research suggests that combining addiction treatment with pain management, like using buprenorphine (a medication for opioid use disorder) and counseling, can help manage both opioid use disorder and chronic pain. This approach involves working closely with healthcare providers to tailor the treatment to individual needs, which can improve outcomes. ^{3 10 11 12 13}

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Integrated outpatient treatment of opioid use disorder and injection-related infections: A description of a new care model. [2020]

3. England 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. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Factors Associated With the Presence of Co-occurring Pain and Substance Use Disorder Programs in Substance Use Treatment Facilities. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Undertreatment of opioid use disorder in patients hospitalized with injection drug use-associated infections. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Brief Screening Tool for Opioid Use Disorder: EMPOWER Study Expert Consensus Protocol. [2021]

7. England 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. [2021]

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

Developing an opioid use disorder treatment cascade: A review of quality measures. [2022]

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

Implementation of the hub and spoke model for opioid use disorders in California: Rationale, design and anticipated impact. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Comorbid chronic pain and opioid use disorder: literature review and potential treatment innovations. [2019]

11. United States 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. [2022]

12. United States 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. [2021]

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

Development and validation of the Capacity to Treat Chronic Pain and Opioid Use Disorder (CAP-POD) questionnaire. [2023]