Buprenorphine Microdosing for Opioid Use Disorder

(Micro-bupe Trial)

No longer recruiting at 1 trial location

Overseen By Megan Ghiroli

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Aaron D. Fox

Must be taking: Opioids

Must not be taking: BUP, Methadone, Naltrexone

Disqualifiers: Severe alcohol, Benzodiazepine, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to initiating treatment for individuals with opioid use disorder (OUD). Researchers compare a microdosing method, where patients begin with very low doses of buprenorphine (BUP) while continuing their current opioid use, to the usual method that requires patients to stop opioids and undergo withdrawal first. The goal is to determine if the microdosing method is easier or more effective. Individuals who misuse opioids, have chronic pain, and are currently taking opioids might be suitable candidates, particularly if they have a planned hospital stay of at least 48 hours. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how it can benefit more patients.

Do I have to stop taking my current medications for the trial?

If you are in the microdosing group, you can continue taking your current opioids. However, if you are in the treatment as usual group, you will need to stop taking other opioids and go through withdrawal before starting the trial medication.

What is the safety track record for these treatments?

Research has shown that buprenorphine, a medication often used to treat opioid addiction, is generally safe. One study found that buprenorphine is safer than methadone, another common treatment for opioid addiction, making it a popular choice in many countries, such as Australia.

Researchers are studying the microdose induction method for its safety and effectiveness. This method involves starting with very small doses of buprenorphine to help patients switch from their current opioids without experiencing withdrawal symptoms. In some studies, many patients successfully switched to buprenorphine using this approach.

Overall, buprenorphine, even in small starting doses, is usually well-tolerated. There are no widespread reports of serious side effects when starting at these lower doses. However, anyone considering joining a trial should discuss possible side effects with the trial team, who can provide the most current information and support. ^{1 2 3 4 5}

Why are researchers enthusiastic about this trial?

Researchers are excited about the Buprenorphine microdose induction protocol for opioid use disorder because it offers a new approach to transitioning patients onto Buprenorphine (BUP) without the typical withdrawal symptoms. Unlike the standard treatment, which often requires patients to stop opioids completely before starting BUP, this microdosing method allows for a smoother induction by gradually introducing the medication in small doses. This could potentially lead to higher treatment retention rates and greater overall success in managing opioid dependency.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that small doses of buprenorphine can effectively treat opioid addiction. In this trial, participants in the BUP microdose induction arm will follow a novel protocol to prevent withdrawal symptoms, easing the start of treatment. This approach avoids the discomfort often associated with stopping other opioids before beginning treatment. Additionally, buprenorphine is considered safer than methadone, another treatment option for opioid addiction. Overall, evidence suggests that buprenorphine microdosing offers a promising way to manage this condition. ^{1 5 6 7 8}

Who Is on the Research Team?

Aaron Fox, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with opioid misuse or disorder and chronic pain, who are currently taking opioids and can speak English or Spanish. They must be hospitalized for at least 48 hours but not already in treatment for opioid use disorder, have severe alcohol or benzodiazepine use disorders, cancer-related pain, untreated severe mental illness, pregnancy, or inability to consent.

Inclusion Criteria

I will be in the hospital for at least 2 days.

I am currently using opioid medication.

I experience chronic pain.

Exclusion Criteria

I am currently being treated for opioid use disorder.

You have a serious mental illness that has not been treated. This includes thoughts of suicide or experiencing psychosis.

I experience pain because of my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants undergo a 5-day BUP microdose induction protocol or a 2-day standard induction protocol during hospitalization

1 week

Daily visits during hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 week, 1 month, 3 months, and 6 months

6 months

4 visits (in-person or virtual)

Long-term follow-up

Participants are assessed for BUP retention in care and illicit opioid use

6 months

What Are the Treatments Tested in This Trial?

Interventions

• BUP microdose induction
• Linkage to outpatient BUP treatment
• TAU

Trial Overview The study compares a new way of starting BUP (buprenorphine-naloxone) treatment without stopping other opioids first (BUP microdose induction) against the usual method where patients stop other opioids and go through withdrawal before starting BUP. Participants will be randomly assigned to one of these two approaches.

How Is the Trial Designed?

Group I: BUP microdose induction Experimental Treatment 2 Interventions

Participants in this arm will receive a novel BUP microdose induction protocol.

Group II: Treatment As Usual (TAU) Active Control 2 Interventions

Participants in this arm will receive standard BUP induction protocol.

Who Is Running the Clinical Trial?

Aaron D. Fox

Lead Sponsor

Trials

1

Recruited

20+

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Wake Forest University

Collaborator

Trials

193

Recruited

151,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05118204

Randomized Trial of Buprenorphine Microdose Inductions ... These data will allow investigators to assess whether BUP microdosing targets of engagement-opioid- and pain-related symptoms-mediate OUD outcomes. Exploratory ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1555415524003763

Buprenorphine Microdosing the “Bernese Method”: Patient ... Buprenorphine is increasingly favored over methadone for treating opioid use disorder in Australia due to its superior safety profile.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8595358/

Low-Dose Buprenorphine Initiation in Hospitalized Adults ... Of the 72 low-dose buprenorphine initiations 50 (69.4%) were completed in the hospital, 9 (12.5%) transitioned to complete as an outpatient, and 13 (18.1%) were ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8020374/

The Pharmacology of Buprenorphine Microinduction for ... Multiple studies have demonstrated that precipitated withdrawal during induction onto BUP occurs commonly, especially when it is preceded by ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460320308698

Systematic review on effectiveness of micro-induction ... Micro-induction is a novel buprenorphine induction approach that seeks to avoid withdrawal and minimize precipitated withdrawal, both barriers to standard ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11841166/

Initiating buprenorphine to treat opioid use disorder without ... In this updated review, 57 of the 59 included studies reported transition rates to buprenorphine. Of those 57 studies, 81% (451/555) of patients ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05644587

NCT05644587 | Novel Induction to Buprenorphine/Naloxone Primary outcomes include effectiveness and safety. Secondary outcomes include treatment retention, self-reported use of opioids during induction, return to ...

8. tandfonline.com tandfonline.com/doi/abs/10.1080/10550887.2021.1988292

Safety of induction at standard doses of buprenorphine for ... The purpose of this study was to evaluate the safety and efficacy of initiation of buprenorphine for inpatients with OUD.