Frontlight ResearchEarly access
TerminatedPhase 4
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
Key facts
- Who runs it
- Montefiore Medical Center
- Where
- The Bronx, United StatesSee the site
- Trial code
- Status
- Terminated
- Phase
- Phase 4
- People taking part
- 23 people enrolled
- Started
- 29 Sept 2022
- Ended
- 9 Apr 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- BUP microdose induction
- TAU
- Linkage to outpatient BUP treatment
- Record updated
- 8 May 2026
- Why it stopped
- Difficulty recruiting and enrolling participants
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Age > 18 years
- Opioid misuse or OUD
- Chronic pain
- Currently taking opioids
- Fluency in English or Spanish
- Planned hospitalization for ≥ 48 hours
Who cannot take part
- Severe alcohol or benzodiazepine use disorder
- Hypersensitivity to BUP or naloxone
- Pain due to malignancy
- Severe untreated mental illness (suicidality, psychosis)
- Unable to consent due to pain or cognitive impairment
- Current OUD treatment (BUP, methadone, naltrexone)
- Pregnancy
Where in United States
- Montefiore Medical CenterThe Bronx, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- BUP microdose inductionTreatment being tested
Participants in this arm will receive a novel BUP microdose induction protocol.
Treatment: BUP microdose induction and Linkage to outpatient BUP treatment
- Treatment As Usual (TAU)Existing treatment, for comparison
Participants in this arm will receive standard BUP induction protocol.
Treatment: TAU and Linkage to outpatient BUP treatment
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 8 May 2026