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Opioid Agonist
Buprenorphine Microdosing for Opioid Use Disorder (Micro-bupe Trial)
Phase 4
Recruiting
Research Sponsored by Montefiore Medical Center
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, and 6 months
Awards & highlights
Micro-bupe 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.Check my eligibility
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.See study design
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.
Micro-bupe Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently using opioid medication.
Select...
I will be in the hospital for at least 2 days.
Select...
I am older than 18 years.
Micro-bupe Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 3, and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
BUP treatment uptake
Secondary outcome measures
BUP retention in care
Illicit opioid use
Other outcome measures
Pain Intensity
Pain interference
Micro-bupe 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.
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Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
445 Previous Clinical Trials
582,357 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated for opioid use disorder.I am fluent in English or Spanish.I will be in the hospital for at least 2 days.You have a serious mental illness that has not been treated. This includes thoughts of suicide or experiencing psychosis.I am currently using opioid medication.I experience chronic pain.I experience pain because of my cancer.You have a history of misusing opioids or have opioid use disorder.You have a serious problem with alcohol or benzodiazepine use.I am allergic to BUP or naloxone.I am older than 18 years.
Research Study Groups:
This trial has the following groups:- Group 1: BUP microdose induction
- Group 2: Treatment As Usual (TAU)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being accepted into this experimental research?
"Affirmative. The entry posted on clinicaltrials.gov reveals that this medical research is actively enrolling participants, with the first post made on August 29th 2022 and most recent update on September 28th 2022. This trial seeks to recruit a total of 270 individuals at one study site."
Answered by AI
Is BUP microdose induction a safe method of therapy for patients?
"BUP microdose induction has been approved for use, so its safety rating on our scale of 1 to 3 is a solid 3."
Answered by AI
Is this investigation presently open to participants?
"According to clinicaltrials.gov, this medical experiment was initially posted on August 29th 2022 and its recruitments are still ongoing; the most recent update being dated September 28th 2022."
Answered by AI
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