Clinical trial NCT06855732: Pain Self-Management and Treatment Engagement for Patients Taking Opioids
Official title: Pain Self-Management Intervention to Reduce Pain & Improve MOUD Engagement in Primary Care: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Opioid Use Disorder
Opioid Misuse and Addiction
Keywords: pain
opioid
primary care
behavioral health
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-03-04
Enrollment: 378
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized 1:1 to either PSM or Usual Care.

The intervention will be completed in 12 weeks and will take place between the baseline and 3-month (post-intervention) visit.
Primary purpose: TREATMENT

Brief summary: 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 (OUD) The main questions it aims to answer are:

* Does PSM help participants manage their chronic pain more effectively?
* Does PSM help participants engage in treatment for opioid use?

Researchers will compare PSM to standard care to see if PSM is effective in managing chronic pain and engagement in treatment.

Participants will:

* Take part in the PSM program or receive standard care for 12 weeks after enrolling in the study
* Complete surveys every 3 months for 9 months (total of 4 visits)

Participants will receive compensation for participating in the study.

There are risks associated with participating in the study, including breach of confidentiality and psychological distress caused by discussing difficult topics.

Detailed description: This is randomized trial of a pain self-management (PSM) intervention for chronic pain tailored to individuals with opioid misuse or opioid use disorder (OUD) as compared to usual care. The investigators hypothesize that PSM will be effective in improving both reducing pain and improving MOUD engagement among individuals with co-occurring opioid misuse/OUD and chronic pain.

This is a multisite trial recruiting from primary care clinics located in Pennsylvania, West Virginia and Maryland.

Interventions: Participants will be randomized to either PSM or Usual Care.

Pain Self-Management (PSM): 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.

Usual Care (UC): Usual care or "treatment as usual" refers to the standard of care that patient participants receive at their primary care clinic. The standard of care for patients is to discuss issues related to chronic pain and opioid use with their providers and to receive clinical care for these conditions.

Study Duration: \~27 months (18 months of recruitment + 9 months follow-up) Participant Duration: 9 months

Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Adults at least 18 years old
2. Ability to speak, read, and understand English
3. Capable of providing informed consent
4. Access to phone and/or internet
5. Current (defined as at least 1 primary care visit in the past 3 years) or new (confirmed appointment) primary care patient at a participating clinic
6. Must meet criteria for OUD or opioid misuse based on at least one of the following:

   1. OUD Misuse Screening score of 3 or more (sometimes or more) on at least one of the questions
   2. Meets criteria for DSM-5 Opioid Use Disorder on MINI-J
   3. Documented diagnosis of Opioid use Disorder (OUD)
7. Have bothersome (Grade 2) or high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R)

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Under 18 years of age
2. Have cancer-related pain
3. Are currently in jail, prison, overnight/residential facility as required by court of law or have pending legal action that could prevent participation in study activities
4. Have received prescribed, administered, or dispensed MOUD (buprenorphine, methadone, naltrexone) as maintenance treatment for OUD (excluding acute or short-term (\< 7 days) use of these medications to manage opioid withdrawal or pain management) within the past 90 days
5. Had an intentional suicide attempt within the past 3 months

The investigators will not exclude individuals with common comorbidities, such as depression, anxiety, or alcohol, methamphetamine, and other substance use disorders.

Primary outcomes:
measure: Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline
timeFrame: Baseline, 3 Months
measure: Proportion of Participants that Engage in MOUD Treatment at 3 months Post-baseline
timeFrame: Baseline, 3 Months
Secondary outcomes:
measure: Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline
timeFrame: Baseline, 3 Months
measure: Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline
timeFrame: Baseline, 3 Months
measure: Number of Days Participants took MOUD at 6-months Post-baseline
timeFrame: 6 Months
measure: Change from Baseline in Self-Efficacy at 3 months Post-baseline
timeFrame: Baseline, 3 Months
measure: Number of Days Non-prescribed Opioids were Used in the past 30 days as Assessed by the Modified ASI at 3-months Post-baseline
timeFrame: 3 Months
measure: Total score on the IMPOWR Opioid Misuse Screening scale at 3 months Post-baseline
timeFrame: 3 Months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Community Medicine, Inc.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC General Internal Medicine-Montefiore
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC General Internal Medicine-Shadyside (Shea Medical Center)
state: Pennsylvania
city: Turtle Creek
country: United States
facility: UPMC General Internal Medicine-Turtle Creek
state: Pennsylvania
city: West Mifflin
country: United States
facility: UPMC General Internal Medicine-South
state: Pennsylvania
city: Buckhannon
country: United States
facility: St. Joseph's Rural Health Clinic (WVU Medicine)
state: West Virginia
city: Harpers Ferry
country: United States
facility: Harpers Ferry Family Medicine (WVU Medicine)
state: West Virginia
city: Morgantown
country: United States
facility: WVU Medicine University Town Centre
state: West Virginia
city: Shepherdstown
country: United States
facility: WVU Medicine Primary Care
state: West Virginia
Study officials:
affiliation: University of Pittsburgh
name: Erin Winstanley, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Jessica Merlin, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References: