Buprenorphine Microdosing for Opioid Use Disorder

(Micro-bupe Trial)

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

23 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Investigators will test a novel protocol for starting BUP (buprenorphine-naloxone) treatment. The BUP microdose induction protocol has participants start very low doses of BUP without stopping other opioids that they are taking. The treatment as usual (TAU) has participants stop other opioids and experience opioid withdrawal before starting BUP. Investigators propose to test BUP microdose inductions vs. TAU in a randomized controlled trial.

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+