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Opioid Agonist

Buprenorphine Microdosing for Opioid Use Disorder (Micro-bupe Trial)

Phase 4
Recruiting
Research Sponsored by Aaron D. Fox
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently taking opioids
Planned hospitalization for ≥ 48 hours
Must not have
Current OUD treatment (BUP, methadone, naltrexone)
Pain due to malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, and 6 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the effects of two different methods of starting buprenorphine treatment - a microdose induction and the usual treatment protocol.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from BUP include nausea, headaches, drowsiness, constipation and potential allergic reactions. The severity of side effects may vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently using opioid medication.
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I will be in the hospital for at least 2 days.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for opioid use disorder.
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I experience pain because of my cancer.
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I am allergic to BUP or naloxone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BUP treatment uptake
Secondary study objectives
BUP retention in care
Illicit opioid use
Other study objectives
Pain Intensity
Pain interference

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BUP microdose inductionExperimental Treatment2 Interventions
Participants in this arm will receive a novel BUP microdose induction protocol.
Group II: Treatment As Usual (TAU)Active Control2 Interventions
Participants in this arm will receive standard BUP induction protocol.

Find a Location

Who is running the clinical trial?

Aaron D. FoxLead Sponsor
National Institute on Drug Abuse (NIDA)NIH
2,592 Previous Clinical Trials
3,328,410 Total Patients Enrolled
Montefiore Medical CenterLead Sponsor
457 Previous Clinical Trials
588,339 Total Patients Enrolled

Media Library

BUP microdose induction (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05118204 — Phase 4
Opioid Use Disorder Research Study Groups: BUP microdose induction, Treatment As Usual (TAU)
Opioid Use Disorder Clinical Trial 2023: BUP microdose induction Highlights & Side Effects. Trial Name: NCT05118204 — Phase 4
BUP microdose induction (Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05118204 — Phase 4
~108 spots leftby Jul 2026
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