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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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