RECRUITING

Pain Self-Management and Treatment Engagement for Patients Taking Opioids

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pain Self-Management Intervention to Reduce Pain & Improve MOUD Engagement in Primary Care: a Randomized Trial

Quick Facts

Study Start:2024-11-25
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06855732

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults at least 18 years old
  2. 2. Ability to speak, read, and understand English
  3. 3. Capable of providing informed consent
  4. 4. Access to phone and/or internet
  5. 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. 6. Must meet criteria for OUD or opioid misuse based on at least one of the following:
  7. 1. OUD Misuse Screening score of 3 or more (sometimes or more) on at least one of the questions
  8. 2. Meets criteria for DSM-5 Opioid Use Disorder on MINI-J
  9. 3. Documented diagnosis of Opioid use Disorder (OUD)
  10. 7. Have bothersome (Grade 2) or high impact chronic pain (Grade 3), based on the Graded Chronic Pain Scale-Revised (GCPS-R)
  1. 1. Under 18 years of age
  2. 2. Have cancer-related pain
  3. 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. 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. 5. Had an intentional suicide attempt within the past 3 months

Contacts and Locations

Study Contact

Melessa Salay, MPH
CONTACT
412-648-7896
TREETOP@pitt.edu

Principal Investigator

Erin Winstanley, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Jessica Merlin, MD, PhD, MBA
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

Community Medicine, Inc.
Pittsburgh, Pennsylvania, 15213
United States
UPMC General Internal Medicine-Montefiore
Pittsburgh, Pennsylvania, 15213
United States
UPMC General Internal Medicine-Shadyside (Shea Medical Center)
Pittsburgh, Pennsylvania, 15232
United States
UPMC General Internal Medicine-Turtle Creek
Turtle Creek, Pennsylvania, 15145
United States
UPMC General Internal Medicine-South
West Mifflin, Pennsylvania, 15122
United States
St. Joseph's Rural Health Clinic (WVU Medicine)
Buckhannon, West Virginia, 26201
United States
Harpers Ferry Family Medicine (WVU Medicine)
Harpers Ferry, West Virginia, 25425
United States
WVU Medicine University Town Centre
Morgantown, West Virginia, 26501
United States
WVU Medicine Primary Care
Shepherdstown, West Virginia, 25419
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Erin Winstanley, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh
  • Jessica Merlin, MD, PhD, MBA, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-25
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-11-25
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • pain
  • opioid
  • primary care
  • behavioral health

Additional Relevant MeSH Terms

  • Chronic Pain
  • Opioid Use Disorder
  • Opioid Misuse and Addiction