Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization

Chronic Pain Clinical Trial

— Micro-bupe  

Official title:

Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05118204
• Other study ID #: 2021-13311
• Secondary ID: 1RM1DA055437-01
• Status: Recruiting
• Phase: Phase 4
• Start date: September 29, 2022
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Montefiore Medical Center
• Contact: Megan Ghiroli
• Phone: 203-606-8136
• Email: mghiroli[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: December 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Drug:
• BUP microdose induction
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
• TAU
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

Behavioral:
• Linkage to outpatient BUP treatment
Participants will be given an expedited appointment (within 2 weeks) to continue BUP treatment at a Montefiore community health center

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Aaron D. Fox	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Intensity	Mean pain intensity score, measured using the Brief Pain Inventory (BPI), will be reported for each study arm.	3 months
Other	Pain interference	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
Primary	BUP treatment uptake	The percentage of participants who start BUP treatment, defined as receiving BUP 7 days after the baseline visit, will be reported for each arm.	7 days
Secondary	Illicit opioid use	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
Secondary	BUP retention in care	The 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.	6 months