Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes
Persist
3 other identifiers
interventional
200
1 country
2
Brief Summary
The purpose of this research study is to look at the effect of programs aimed at helping people manage chronic pain and medication treatment. The program sessions focus on educational information and strategies for pain and medication management. The researchers enroll people who have chronic pain and have recently begun buprenorphine treatment to see if participants could benefit from these programs. This research study will help the researchers learn how to improve current therapies for pain and medication management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
August 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2025
CompletedResults Posted
Study results publicly available
July 9, 2025
CompletedJuly 9, 2025
June 1, 2025
3.8 years
June 12, 2020
May 15, 2025
June 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months
In this study, "retention on buprenorphine treatment" was defined as the time until a participant stopped taking their medication for 7 or more days in a row. This information was collected using a calendar recall method, the TimeLine Follow-Back (TLFB) measure at 3 months. The average number of days participants remained on buprenorphine before this happened was calculated, using the data collected at 3-month follow-up.
3-months post enrollment
Secondary Outcomes (7)
Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 12 Months
12-months post enrollment
Average Change in Self-reported Level of Pain Intensity on the Numerical Rating Scale for Pain Intensity (NRS-I) at 3-month Follow up (Compared to Baseline)
3-months post enrollment
Average Change in Self-Reported Level of Pain Related Functioning on the Brief Pain Inventory - Short Form (BPI) at 3-month Follow up (Compared to Baseline)
3-months post enrollment
Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-months
3-months post enrollment
Average Change in Self-reported Level of Pain Intensity on the Numerical Rating Scale for Pain Intensity (NRS-I) at 12-month Follow up (Compared to Baseline)
12-months post enrollment
- +2 more secondary outcomes
Study Arms (2)
Psychosocial Pain Management (PPMI)
EXPERIMENTALEight Cognitive Behavioral Therapy-based individual telephone or video therapy sessions with research study therapist.
Enhanced Usual Care (EUC)
ACTIVE COMPARATORTwo individual telephone educational sessions with research study therapist.
Interventions
The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
Eligibility Criteria
You may qualify if:
- having a diagnosis of an opioid use disorders (OUD) within the past 12 months;
- started buprenorphine (the term we use to refer to all buprenorphine products including buprenorphine/naloxone) treatment within the past 6 months
- at least moderate or greater self-reported pain on average over the past 3 months;
- regular and consistent access to a telephone and willingness to use the phone for study sessions.
You may not qualify if:
- buprenorphine medication prescribed in the form of a monthly injection and/or a transdermal patch
- self-reported pregnancy at the time of study enrollment
- currently living outside of the United States
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Veterans Affair Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105, United States
Michigan Medicine
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Ilgen M, Blow F, Piette JD, Goldstick J, Lewis M, Priest W, Matharu H, Bourgoise M, Young C, Ashe D, Price A, Lin LA. The psychosocial pain management to improve opioid use disorder treatment outcomes study: Protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Nov;158:108081. doi: 10.1016/j.cct.2025.108081. Epub 2025 Sep 17.
PMID: 40972890DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Mark Ilgen
- Organization
- University of Michigan Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Allison Lin, M.D., M.S.
University of Michigan
- PRINCIPAL INVESTIGATOR
Mark Ilgen, Ph.D.
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
June 12, 2020
First Posted
June 16, 2020
Study Start
August 14, 2020
Primary Completion
May 23, 2024
Study Completion
January 19, 2025
Last Updated
July 9, 2025
Results First Posted
July 9, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share