Opioid Use DisorderBup-MBCNCT07839182
Measurement-Based Care to Support Buprenorphine-Naloxone Treatment in Outpatient Addiction Clinics
A study testing Bup-MBC in people with Opioid Use Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Bup-MBC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Patients who are incarcerated or under correctional custody such that research procedures cannot be conducted.
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Thomas Reese, PharmD, PhD, 6153228682, thomas.reese@vumc.org
About this study
Official title: Measurement-based Care to Support Delivery of 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.
Read the detailed description
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.
- Conditions
- Opioid Use Disorder
- Being tested
- Bup-MBC
- Keywords
- patient-reported outcome measures, implementation science, measurement-based care
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bup-MBCBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Bup-MBC | Experimental | 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. Receives: Behavioral: Bup-MBC |
| Usual care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
Proportion of eligible patients randomized to Bup-MBC who complete ≥1 questionnaire; monthly completion rates with 95% confidence intervals
Measured: From enrollment to the end of the study period (12 months) or 6 months, whichever is shorter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients with an active bup-nx prescription under a participating prescriber are individually randomized 1:1 to receive Bup-MBC or usual care, stratified by prescriber. Clinicians are unblinded after assignment and may care for patients in both arms; Bup-MBC summaries and outreach options are available only for patients randomized to the intervention arm.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Reese, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839182
- Sponsor's protocol ID
- K08HS029695
- Acronym
- Bup-MBC
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement-based Care to Support Delivery of Buprenorphine-naloxone Treatment in Outpatient Addiction Clinics
- ClinicalTrials.gov ID
- NCT07839182
- Acronym / sponsor ID
- Bup-MBC / K08HS029695
- Conditions
- Opioid Use Disorder
- Keywords
- patient-reported outcome measures, implementation science, measurement-based care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible patients with an active bup-nx prescription under a participating prescriber are individually randomized 1:1 to receive Bup-MBC or usual care, stratified by prescriber. Clinicians are unblinded after assignment and may care for patients in both arms; Bup-MBC summaries and outreach options are available only for patients randomized to the intervention arm.
| Arm | Type | Receives |
|---|---|---|
| Bup-MBC | Experimental | Behavioral: Bup-MBCPatients 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 care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients who are incarcerated or under correctional custody such that research procedures cannot be conducted.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bup-MBCElectronic 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. | Behavioural | Bup-MBC |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Opioid Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bup-MBC in people with Opioid Use Disorder, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Reese, PharmD, PhD (6153228682, thomas.reese@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: From enrollment to the end of the study period (12 months) or 6 months, whichever is shorter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.