N/A
N=200
Psychosocial Pain Management to Improve Opioid Use Disorder Treatment Outcomes
Opioid-use Disorder · Medication Assisted Treatment · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04433975 ↗Enrolled (actual)
200
Serious AEs
18.0%
Results posted
Jul 2025
Primary outcome: Primary: Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months — 81.1; 75.4 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Psychosocial Pain Management (PPMI) (Behavioral); Enhanced Usual Care (EUC) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-months |
81.1; 75.4 | — |
| SECONDARY Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 12 Months |
252.1; 236.5 | — |
| SECONDARY 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) |
-0.7; -1.1 | — |
| SECONDARY 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) |
-0.3; -0.8 | — |
| SECONDARY Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-months |
76.7; 74.2 | — |
| SECONDARY 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) |
-1.5; -1.9 | — |
| SECONDARY Average Change in Self-Reported Level of Pain Related Functioning on the Brief Pain Inventory - Short Form (BPI) at 12-month Follow up (Compared to Baseline) |
-0.6; -0.9 | — |
| SECONDARY Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 12 Months |
74.7; 79.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04433975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.