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

Key facts

Who runs it
Vanderbilt University Medical Center
Where
Nashville, United StatesSee the site
Trial code
Status
Not yet recruiting
People taking part
140 people, planned
Starts
1 Dec 2026
Expected to end
1 Dec 2027
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Bup-MBC
Record updated
30 September 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Adult (age ≥18)
  • Active bup-nx prescription under a participating prescriber at one of the VUMC addiction clinics
  • Enrolled in and active in the respective clinic
  • Activated patient portal account

Who cannot take part

  • Patients unable to provide informed consent because of severe cognitive impairment or acute intoxication at the time of approach, as judged by the treating clinician
  • Patients whose clinicians judge that participation would pose undue risk or burden (e.g., acute psychiatric crisis where additional questionnaires would be inappropriate)
  • Patients who are incarcerated or under correctional custody such that research procedures cannot be conducted

Where in United States

  • Vanderbilt University Medical CenterNashville, United StatesContact: Thomas Reese, PharmD, PhDNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Bup-MBCTreatment being tested

    Patients seen by a provider randomized to Bup-MBC receive automated between-visit PROMs via patient portal or secure text, immediate tailored non-punitive feedback after completion, eligibility for clinician-facing EHR summaries with non-directive prompts, and an opt-in option to request earlier contact between visits, with predefined safety overrides for critical disclosures.

  • Usual careNo study treatment, for comparison

    Patients seen by a provider randomized to usual care continue to receive standard buprenorphine-naloxone treatment and routine clinic services without PROM invitations or Bup-MBC components.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Measurement-based Care to Support Delivery of Buprenorphine-naloxone Treatment in Outpatient Addiction Clinics
Record updated
30 September 2026