Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization (Micro-bupe)
Study Overview
Status
Intervention / Treatment
Detailed Description
Investigators will conduct a hybrid type 1 effectiveness-implementation study, using a pragmatic, open-label, randomized controlled trial (RCT). Investigators will randomize 270 hospitalized patients with (a) chronic pain and (b) opioid misuse or opioid use disorder (OUD) to a 5-day BUP microdose induction protocol (without stopping full agonists) or 2-day standard induction (with stopping full agonists), and then link participants to outpatient BUP treatment when they are released from the hospital. Study assessment visits will occur at baseline, 1 week, and 1, 3, and 6 months. Assessments will include interviews and urine drug tests to determine whether participants start BUP, continue BUP, have improvements in pain and decrease illicit opioid use. During induction and 3-months of follow-up, investigators will also collect data on mobile devices to assess opioid withdrawal, opioid craving, pain, and anxiety. These data will allow investigators to assess whether BUP microdosing targets of engagement-opioid- and pain-related symptoms-mediate OUD outcomes. Exploratory analyses will also examine pain as a trigger for opioid relapse.
Aim 1: To test the effectiveness of BUP microdose induction (vs. TAU) on OUD outcomes.
H1: The microdose arm (vs. TAU) will have better BUP treatment uptake and retention, and less illicit opioid use.
H2: Improvements in H1 will be mediated by opioid- and pain-related symptoms.
Aim 2: To test the effectiveness of microdosing (vs. TAU) on pain outcomes. H3: The microdose arm (vs. TAU) will have less pain intensity and interference, and improved quality of life.
H4: Improvements in H3 will be mediated by OUD outcomes.
Aim 3: To inform future implementation and dissemination efforts, investigators will:
3a) Examine factors influencing reach, adoption, implementation, and maintenance of BUP microdosing. Investigators will use qualitative and quantitative methods to describe multi-level factors influencing these domains; 3b) Calculate the cost and examine cost-effectiveness of BUP microdosing. H5: Compared with TAU, BUP microdosing will be cost-effective from a societal and a health sector perspective.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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New York
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The Bronx, New York, United States, 10467
- Montefiore Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 18 years
- Opioid misuse or OUD
- Chronic pain
- Currently taking opioids
- Fluency in English or Spanish
- Planned hospitalization for ≥ 48 hours
Exclusion Criteria:
- Current OUD treatment (BUP, methadone, naltrexone)
- Severe alcohol or benzodiazepine use disorder
- Hypersensitivity to BUP or naloxone
- Pain due to malignancy
- Severe untreated mental illness (suicidality, psychosis)
- Pregnancy
- Unable to consent due to pain or cognitive impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BUP microdose induction
Participants in this arm will receive a novel BUP microdose induction protocol.
|
Participants will be started on a 5-day BUP microdose induction protocol (without stopping full agonists). Day 1: participants will receive buprenorphine (Belbuca) 225 mcg mg every 12 hours Day 2: participants will receive buprenorphine (Belbuca) 450 mcg every 8 hours Day 3: participants will receive buprenorphine-naloxone 2-0.5 mg every 8 hours Day 4: participants will receive buprenorphine-naloxone 4-1 mg every 8 hours Day 5: participants will receive buprenorphine-naloxone 8-2 mg every 12 hours
Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
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Active Comparator: Treatment As Usual (TAU)
Participants in this arm will receive standard BUP induction protocol.
|
Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center
2-day standard BUP induction protocol (with stopping full agonists) Day 1: hold all opioids Day 2: buprenorphine-naloxone 2-0.5 mg every 6 hours Day 3: buprenorphine-naloxone 8-2 mg every 12 hours
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BUP Treatment Uptake
Time Frame: 7 days
|
The percentage of participants who start BUP treatment, defined as receiving BUP 7 days after the baseline visit, will be reported for each arm.
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7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Illicit Opioid Use
Time Frame: 1, 3, and 6 months
|
The mean number of days of illicit opioid use, defined as self-reported use of heroin, fentanyl, or non-prescribed opioid analgesics in the prior 30 days based on the Addiction Severity Index, will be reported for each arm.
|
1, 3, and 6 months
|
|
BUP Retention in Care
Time Frame: 1, 3, and 6 months
|
The number/percentage of participants who are retained in BUP treatment, defined as having a BUP prescription written 180-210 days (6-month retention) after enrollment, will be reported for each arm.
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1, 3, and 6 months
|
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Pain Intensity
Time Frame: 3 months
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Mean pain intensity score, measured using the Brief Pain Inventory (BPI), will be reported for each study arm.
The pain intensity score has 4 items that are each rated on a scale from 0 (low intensity) to 10 (high intensity).
The score reported is the average score from the 4-items also reported on a scale of 0-10.
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3 months
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Pain Interference
Time Frame: 3 months
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Mean pain interference score, measured using the pain interference scale from the BPI, which is a 7-item instrument measuring the impact of pain on daily activities and physical functioning, will be reported for each study arm.
Each item is rated on a scale from 0 (low interference) to 10 (high interference).
The score reported is the average score from the 7-items also reported on a scale of 0-10.
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3 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 3 months
|
Mean pain intensity score, measured using the Brief Pain Inventory (BPI), will be reported for each study arm.
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3 months
|
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Pain interference
Time Frame: 3 months
|
Mean pain interference score, measured using the pain interference scale from the BPI, which is a 7-item instrument measuring the impact of pain on daily activities and physical functioning, will be reported for each study arm.
|
3 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Aaron Fox, MD, Montefiore Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-13311
- 1RM1DA055437-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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