Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
TerminatedPhase 4NCT05118204
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
- Conditions
- Substance Use Disorders
- Opioid-use Disorder
- Chronic Pain
- Interventions
- Drug: BUP microdose induction
- Drug: TAU
- Behavioral: Linkage to outpatient BUP treatment
- Sponsor
- Montefiore Medical Center
- Collaborators
- National Institute on Drug Abuse (NIDA); Weill Medical College of Cornell University; Wake Forest University
- Start date
- 2022-09-29
- Primary completion
- 2024-10-23
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05118204