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NCT Number: NCT07839182

Measurement-Based Care to Support Buprenorphine-Naloxone Treatment in Outpatient Addiction Clinics

People receiving buprenorphine-naloxone (bup-nx) for opioid use disorder often face changes in cravings, withdrawal, and return to use risk between clinic visits, but their care team may not know about these changes until the person misses an appointment or returns to drug use. Measurement-based care (MBC) uses brief, repeated check-ins from patients to make these between-visit changes visible. This study tests "Bup-MBC," a strategy that sends patients short questionnaires through their patient portal or by text before and between visits, gives them immediate supportive feedback, shares summary information with their prescriber in the electronic health record, and offers an option to request earlier contact if concerns arise. The study will include providers and patients at outpatient addiction clinics at Vanderbilt University Medical Center, randomly assigned to either receive Bup-MBC or usual care, and followed for 6 months. The main goal is to determine whether Bup-MBC can be practically delivered in routine addiction clinics and whether patients and providers use it.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

About this study

Bup-MBC is an electronic health record-embedded implementation strategy designed to support evidence-based buprenorphine-naloxone (bup-nx) treatment for opioid use disorder (OUD) by integrating patient-reported outcome measures (PROMs) and related indicators into routine outpatient addiction care. The strategy comprises four components: (1) structured between-visit PROMs assessing withdrawal, craving, medication adherence, medication side effects, opioid overdose risk, other substance use, global treatment improvement, and recovery community connection; (2) automated non-punitive patient feedback immediately following PROM completion; (3) EHR-embedded longitudinal clinician-facing summaries with non-directive decision-support prompts; and (4) an opt-in between-visit outreach pathway with predefined safety overrides for critical disclosures.

This pragmatic pilot hybrid type III effectiveness-implementation trial will enroll adults with an active bup-nx prescription at outpatient addiction clinics at Vanderbilt University Medical Center (Bridge Clinic, Vanderbilt Recovery Clinic, and Firefly Clinics). Providers will be individually randomized 1:1 to Bup-MBC or usual care. The 6-month observation period will evaluate implementation outcomes using the RE-AIM framework (Reach, Adoption, Implementation) as primary outcomes, and exploratory clinical outcomes including medication possession ratio, visit adherence, treatment retention, urgent refill requests, emergency department utilization, and urine drug screen results. Qualitative interviews with clinicians and clinic leadership will assess acceptability, feasibility, and sustainability.

Bup-MBC and this study were developed following a qualitative needs assessment, systematic review of single-item PROMs for substance use treatment, and theory-guided intervention design using the Theoretical Domains Framework and COM-B.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) Adult (age ≥18); (2) Active bup-nx prescription under a participating prescriber at one of the five VUMC addiction clinics (Bridge Clinic, Vanderbilt Recovery Clinic, or Firefly Clinic); (3) Enrolled in and active in the respective clinic

Exclusion criteria

  • NA

Treatment and study plan

Bup-MBC

Behavioral

Electronic health record-embedded implementation strategy comprising four components: (1) brief repeated PROMs delivered via patient portal or secure text (domains: withdrawal, craving, bup-nx adherence, medication side effects, opioid overdose risk, other substance use, global treatment improvement, recovery community connection); (2) automated non-punitive tailored patient feedback following each PROM; (3) longitudinal EHR-embedded clinician-facing summaries with non-directive clinical decision support prompts; (4) opt-in between-visit outreach pathway with predefined safety triggers for urgent follow-up. PROM frequency is adapted to treatment phase and clinical stability.

Primary outcomes

  1. Reach

    Time frame: From enrollment to the end of the study period (12 months) or 6 months, whichever is shorter

    Proportion of eligible patients randomized to Bup-MBC who complete ≥1 questionnaire; monthly completion rates with 95% confidence intervals

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Measurement-based Care to Support Delivery of Buprenorphine-naloxone Treatment in Outpatient Addiction Clinics

Acronym: Bup-MBC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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