Bup-MBC for Opioid Use Disorder
(Bup-MBC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new strategy called Bup-MBC to manage opioid use disorder more effectively. It involves quick check-ins through texts or a patient portal to monitor changes in cravings and withdrawal between doctor visits. The system shares this information with the patient's doctor to catch issues early and provide timely support. This approach suits individuals currently receiving buprenorphine-naloxone (a medication for opioid use disorder) at a Vanderbilt University Medical Center clinic and who have an active patient portal account. The trial aims to determine if this method can be easily implemented in regular addiction clinics and if patients and doctors find it beneficial. As an unphased trial, it offers a unique opportunity to contribute to innovative strategies for managing opioid use disorder.
What prior data suggests that this Bup-MBC strategy is safe for patients with opioid use disorder?
Research has shown that buprenorphine-naloxone (bup-nx) is generally safe and effective for treating opioid use disorder. The FDA has approved this medication to help manage opioid addiction by reducing cravings and withdrawal symptoms through its action on the brain.
While detailed information on Bup-MBC (the measurement-based care strategy) is limited, this approach involves using bup-nx along with regular check-ins to track patient progress. The goal is to identify any changes in cravings or withdrawal early, potentially leading to better treatment outcomes.
Regarding safety, buprenorphine-naloxone has been widely studied, and most patients can use it safely with few serious side effects. Common side effects might include nausea, headaches, or sweating, but these are usually mild. Serious side effects are rare. Patients should always discuss any concerns with their healthcare provider to ensure they receive the best care.12345Why are researchers excited about this trial?
Researchers are excited about the Bup-MBC protocol for opioid use disorder because it integrates technology to enhance patient engagement and treatment outcomes. Unlike the usual care, which primarily involves standard buprenorphine-naloxone treatment, Bup-MBC includes automated patient-reported outcome measures (PROMs) via a patient portal or secure text, providing immediate, personalized feedback. This approach allows patients to request earlier contact with their clinician if needed, potentially addressing issues more proactively. Additionally, it offers clinician-facing summaries with non-directive prompts, aiming to improve communication and decision-making. These innovative features may lead to more responsive and personalized care for individuals struggling with opioid use disorder.
What evidence suggests that Bup-MBC is effective for opioid use disorder?
Research has shown that measurement-based care (MBC) can improve treatment outcomes for people with opioid use disorder. Studies have found that MBC methods, such as regular patient check-ins and feedback collection, help track symptoms and quickly adjust treatment plans. One review highlighted the effectiveness of patient-reported outcomes in monitoring progress in substance use treatment. Additionally, incorporating technology in MBC practices has been linked to symptom improvements. In this trial, participants in the Bup-MBC arm will receive automated between-visit PROMs and tailored feedback, suggesting that Bup-MBC could effectively manage opioid use disorder by providing timely support and care adjustments.678910
Are You a Good Fit for This Trial?
This trial is for adults receiving buprenorphine-naloxone treatment for opioid addiction at outpatient clinics. Participants must be able to use a patient portal or receive text messages and are being treated at Vanderbilt University Medical Center.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive buprenorphine-naloxone treatment with measurement-based care (Bup-MBC) or usual care
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bup-MBC
Trial Overview
The study tests 'Bup-MBC,' which uses short, regular questionnaires sent by text or online to monitor patients' symptoms between visits. Patients get feedback and can request help sooner if needed. Clinics are randomly assigned to use Bup-MBC or continue usual care over 6 months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Citations
1.
researchgate.net
researchgate.net/figure/Raw-average-of-percent-improvement-outcomes-across-the-three-phases-stratified-by_tbl2_398084153Raw average of percent improvement outcomes across the three ...
This study examined the outcomes of an organization-wide implementation of MBC in a technology-supported psychotherapy practice. Outcomes were patient symptom ...
2.
semanticscholar.org
semanticscholar.org/paper/Patient-reported-outcomes-for-monitoring-substance-Reese-Tindle/160f01d955a597e299cfbea9bf0ba778fbdc9022Patient-reported outcomes for monitoring substance use treatment
Patient-reported outcomes for monitoring substance use treatment: A systematic review of single-item measures. · Thomas J. Reese, Hilary A. Tindle, +11 authors
A Measurement-Based Care Strategy for Buprenorphine-Naloxone
Conclusion: This development study specifies an EHR-integrated MBC strategy for outpatient bup-nx treatment. As single-center design work with co-design limited ...
John C. Fortney
Given the feasibility and preliminary effectiveness of MBC for bipolar disorder ... Comparing telemedicine to in-person buprenorphine treatment in U.S. veterans ...
ACT + Care Management App for Opioid Use Disorder
Preliminary outcomes suggest that ACT was effective in reducing opioid use while pain interference and mood improved. 4. clinicaltrials.gov. clinicaltrials.gov/ ...
Opioid
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Opioids | National Institute on Drug Abuse (NIDA) - NIH
Clinical trial results support use of weekly extended-release buprenorphine for treatment of opioid use disorder during pregnancy. March 16 ...
I bought an opioid at the gas station, and it was legal. ...
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Opioid Treatment Programs (OTP)
Opioid Treatment Programs (OTPs) provide medications for opioid use disorder (MOUD). OTPs must be certified by SAMHSA and accredited by an ...
Opioids
A person using opioids over time can develop tolerance, physical dependence and opioid use disorder, with the risk of overdose and death. Medical Uses of ...
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