Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-29 @ 6:29 AM
Study NCT ID:
NCT06855732
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2025-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Self-Management and Treatment Engagement for Patients Taking Opioids
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Pain Self-Management Intervention to Reduce Pain & Improve MOUD Engagement in Primary Care: A Randomized Trial
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREETOP
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.
* 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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RM1DA055311 | NIH | None | https://reporter.nih.gov/quic… | View |