ACTIVE_NOT_RECRUITING

Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment

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

This study seeks to improve the treatment of chronic pain in people who are taking buprenorphine (also known as Suboxone, Subutex, Zubsolv). The research study is testing two different interventions along with usual clinical care: 1. Pain Self-Management (PSM): an educational program in which individuals with chronic pain work with a trained pain coach and a pain peer to explore strategies to effectively manage the daily problems that arise from chronic pain. 2. Patient-Oriented Dosing (POD): an alternative dosing of buprenorphine which will be adjusted based on pain levels. The interventions will take place over a period of 12 weeks (3 months). Additionally, participants will complete surveys every 3 months for a period of 1 year (total of 5 survey visits). Participants will receive $50 compensation for each survey visit completed (up to $250 over one year) and can receive up to an additional $100 bonus compensation. There are risks associated with participating in the study, including breach of confidentiality, psychological distress caused by discussing difficult topics, and risks associated with the POD intervention.

Official Title

Pain Self-Management and Patient-Oriented Dosing for Pain and Retention in Office-based Addiction Treatment: a Randomized Trial

Quick Facts

Study Start:2024-05-28
Study Completion:2026-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06367387

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. Patient at a participating clinic
  3. 3. Ability to speak, read, and understand English
  4. 4. Capable of providing informed consent
  5. 5. Access to phone and/or internet
  6. 6. Documented diagnosis of Opioid Use Disorder (OUD)
  7. 7. On a stable dose of an oral or sublingual buprenorphine mono or combination product (\<4 times per day, daily dosage \<32 mg) for at least 7 days during incident new episode of care
  8. 8. Have 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, or overnight facility as required by court of law or have pending legal action that could prevent participation in study activities
  4. 4. Currently prescribed 32mg of an oral or sublingual buprenorphine mono or combination product
  5. 5. Currently prescribed an injectable formulation of buprenorphine
  6. 6. Pregnancy or intention to become pregnant within 4 months of enrollment
  7. 7. Currently prescribed naltrexone or received naltrexone (Vivitrol) injection in the past 60 days
  8. 8. History of hypersensitivity to buprenorphine that a clinician-determined caused serious rash/hives/pruritus, bronchospasm, angioneurotic edema, or anaphylactic shock
  9. 9. Currently prescribed/taking methadone or have taken methadone in the past 30 days
  10. 10. Had an intentional suicide attempt within the past 3 months

Contacts and Locations

Principal Investigator

Erin L Winstanley, PhD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

Alcohol and Drug Abuse Program (ADAP) - UM Addiction Treatment Center
Baltimore, Maryland, 21223
United States
MATClinics
Dundalk, Maryland, 21222
United States
Wells House
Hagerstown, Maryland, 21740
United States
Central City Concern (CCC)
Portland, Oregon, 97209
United States
Recovery Works Northwest (RWNW)
Portland, Oregon, 97233
United States
OHSU Harm Reduction Bridges to Care (HRBR)
Portland, Oregon, 97239
United States
OHSU Internal Medicine Clinic (IMC)
Portland, Oregon, 97239
United States
UPMC Latterman Family Health Center
McKeesport, Pennsylvania, 15132
United States
UPMC St. Margaret Family Health Center
New Kensington, Pennsylvania, 15068
United States
UPMC Magee-Womens Pregnancy and Women's Recovery Center (PWRC)
Pittsburgh, Pennsylvania, 15213
United States
UPMC Internal Medicine Recovery Engagement Program (IM-REP)
Pittsburgh, Pennsylvania, 15219
United States
WVU Crisis Support & Recovery Center
Martinsburg, West Virginia, 25401
United States
WVU Chestnut Ridge Comprehensive Addiction Treatment Program (COAT)
Morgantown, West Virginia, 26505
United States

Collaborators and Investigators

Sponsor: Erin Winstanley

  • Erin L Winstanley, PhD, 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 Date2024-05-28
Study Completion Date2026-10-31

Study Record Updates

Study Start Date2024-05-28
Study Completion Date2026-10-31

Terms related to this study

Keywords Provided by Researchers

  • pain self-management
  • buprenorphine

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Chronic Pain