Bup-MBC for Opioid Use Disorder

(Bup-MBC Trial)

TR
Overseen ByThomas Reese, PharmD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
Must be taking: Buprenorphine-naloxone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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

Enrolled in and active in the respective clinic
I am 18 years old or older.
I have an active buprenorphine-naloxone prescription from a VUMC addiction clinic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive buprenorphine-naloxone treatment with measurement-based care (Bup-MBC) or usual care

6 months
Regular clinic visits with between-visit check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Bup-MBCExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Citations

Raw 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 ...

Patient-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

Opioids are a class of drugs that derive from, or mimic, natural substances found in the opium poppy plant. Opioids work on opioid receptors in the brain ...

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. ...

Gas stations are selling 7-OH, a potent kratom-derived opioid stronger than morphine, while the DEA delays a potential ban.

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 ...