Pain Self-Management and Treatment Engagement for Patients Taking Opioids (TREETOP)

University of Pittsburgh

Status: Enrolling

Conditions: Opioid Misuse and Addiction; Opioid Use Disorder; Chronic Pain

Treatments: Behavioral: Pain Self-Management; Behavioral: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06855732

STUDY24080167

RM1DA055311 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Usual Care

Pain Self-Management (PSM)

Experimental group

Description:

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.

Treatment:

Behavioral: Pain Self-Management