18 and older, any sex, with Opioid-use Disorder or Medication Assisted Treatment. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 3-monthsPrimary· 3-months post enrollment
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.
Group
Value
95% CI
Psychosocial Pain Management (PPMI)
81.1
± 26.6
Enhanced Usual Care (EUC)
75.4
± 32.3
Retention on Buprenorphine Treatment According to TimeLine Follow-Back - 12 MonthsSecondary· 12-months post enrollment
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 12 months. The average number of days participants remained on buprenorphine before this happened was calculated, using the data collected at 12-month follow-up.
Group
Value
95% CI
Psychosocial Pain Management (PPMI)
252.1
± 135.5
Enhanced Usual Care (EUC)
236.5
± 148.9
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)Secondary· 3-months post enrollment
Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0=no pain, 10= worst pain imaginable), which will be collected at the baseline enrollment assessment and 3-month follow-up. To calculate our measure, we subtracted each participant's score at 3-month assessment and subtracted it from their baseline score. We then averaged calculated average change in scores for each intervention group.
Group
Value
95% CI
Psychosocial Pain Management (PPMI)
-0.7
± 1.4
Enhanced Usual Care (EUC)
-1.1
± 2.2
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)Secondary· 3-months post enrollment
Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI), an 11-point numeric rating scale (0 = no pain/does not interfere, 10 = worst pain imaginable/completely interferes). For this study, an increase in pain-related functioning will be measured as a reduction in the pain interference scale scores over time. The BPI interference subscale measures how much pain has interfered with seven daily activities and will provide a current level of pain-related functioning (past 24-hours) at the 3-month follow-up. BPI pain interferenc
Group
Value
95% CI
Psychosocial Pain Management (PPMI)
-0.3
± 2.1
Enhanced Usual Care (EUC)
-0.8
± 2.2
Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 3-monthsSecondary· 3-months post enrollment
Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at 3-month follow-up. During the administration, the participant will be asked to recall their alcohol and drug use utilizing a calendar-assisted structured interview that provides the participant with temporal cues to increase the accuracy of recall. At each follow-up, data will be collected for the entire period since the previous date of data collection. Percent days abstinent from substances (e.g. alcohol and drugs) will be used as the primary measure of substance use. Values shown are the trea
Group
Value
95% CI
Psychosocial Pain Management (PPMI)
76.7
± 37.5
Enhanced Usual Care (EUC)
74.2
± 37.8
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)Secondary· 12-months post enrollment
Pain level will be measured using the Numerical Rating Scale for Pain Intensity (NRS-I), an 11-point numeric rating scale (0 = no pain, 10 = worst pain imaginable), which will be collected at the baseline enrollment assessment and the 12-month follow-up. For each follow-up time point, the baseline value will be subtracted to obtain a change score.
Group
Value
95% CI
Psychosocial Pain Management (PPMI)
-1.5
± 2.2
Enhanced Usual Care (EUC)
-1.9
± 2.6
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)Secondary· 12-months post enrollment
Pain-related functioning will be measured using the pain interference subscale of the Brief Pain Inventory - Short Form (BPI), an 11-point numeric rating scale (0 = no pain/does not interfere, 10 = worst pain imaginable/completely interferes). For this study, an increase in pain-related functioning will be measured as a reduction in the pain interference scale scores over time. The BPI interference subscale measures how much pain has interfered with seven daily activities and will provide a current level of pain-related functioning (past 24-hours) at the 12-month follow-up. BPI pain interferen
Group
Value
95% CI
Psychosocial Pain Management (PPMI)
-0.6
± 2.9
Enhanced Usual Care (EUC)
-0.9
± 2.5
Percent Days Abstinent From Substance Use on the TimeLine Follow-Back - 12 MonthsSecondary· 12-months post enrollment
Frequency of substance use will be measured using the TimeLine Follow-Back and will be collected at the 12-month follow-up. During the administration, the participant will be asked to recall their alcohol and drug use utilizing a calendar-assisted structured interview that provides the participant with temporal cues to increase the accuracy of recall. At each follow-up, data will be collected for the entire period since the previous date of data collection. Percent days abstinent from substances (e.g. alcohol and drugs) will be used as the primary measure of substance use. Values shown are the
Group
Value
95% CI
Psychosocial Pain Management (PPMI)
74.7
± 35.2
Enhanced Usual Care (EUC)
79.6
± 32.0
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04783558 — Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk
· NA
· active not recruiting
NCT05011266 — Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder
· Phase 2, PHASE3
· recruiting
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· recruiting
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Michigan
Last refreshed: 9 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04433975.