Low-dose Buprenorphine Initiation for Opioid Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: buprenorphine-naloxone, buprenorphine-naloxone.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Randomized Controlled Trial of Low-dose Buprenorphine Initiation for Opioid Use Disorder
Overview
The purpose of this study is to test whether low-dose buprenorphine initiation for treatment of opioid use disorder is safe and effective.
Detailed description
After being informed about the study and potential risks, all participants will be given written informed consent. Eligible participants will be randomized in a 1:1 ratio to an 8-day low-dose buprenorphine initiation protocol or treatment as usual, and conduct study visits at baseline and weeks 2 and 4. The investigators will also provide participants with mobile phones to collect real-time data on withdrawal, anxiety, craving and substance use through electronic Ecological Momentary Assessment (EMA) technology.
Interventions
- Drug buprenorphine-naloxone
Low-dose initiation of buprenorphine-naloxone protocol - Drug buprenorphine-naloxone
Standard clinical guidelines for a two-day buprenorphine-naloxone initiation
Primary outcome measures
- Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial. [Time frame: At baseline study visit (time zero)]
Secondary outcome measures (7)
- Protocol Feasibility: Proportion of participants who follow adequate fidelity to the low-dose initiation study protocol. [Time frame: From baseline to day 8]
- Number of participants who uptake buprenorphine treatment at 2 weeks [Time frame: 2-week study visit]
- Number of participants retained in buprenorphine treatment at 6 weeks [Time frame: 6-week study visit]
- Non-prescribed opioid use [Time frame: From baseline to 6-week study visit]
- Withdrawal severity [Time frame: From baseline to 2-week study visit]
- Precipitated withdrawal [Time frame: From baseline to 2-week study visit]
- Mild vs Mod-Severe Withdrawal symptoms [Time frame: From baseline to 2-week study visit]
Eligibility criteria
Inclusion criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Any gender, aged 18 years or greater
- Opioid Use Disorder (based on Diagnostic and Statistical Manual- Version 5 criteria)
- Ability to take sublingual medication
- Willingness to adhere to the assigned buprenorphine initiation regimen
- Fluency in English or Spanish
- For participants of reproductive potential: agreement to use highly effective contraception during study participation
Exclusion criteria
- Use of FDA-approved medications for opioid use disorder treatment (within 7 days prior to screening), including methadone, buprenorphine, or naltrexone
- Diagnosis of Alcohol Use Disorder, severe or Benzodiazepine Use Disorder, severe (based on Diagnostic and Statistical Manual- Version 5 criteria)
- Severe untreated mental illness, meaning psychosis or suicidality
- Presence of an acute or chronic medical condition that would make participation medically hazardous
- Pregnancy or lactation
- Known allergic reactions to buprenorphine or naloxone
- Inability to consent due to cognitive impairment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Montefiore Medical Center — The Bronx
Publications
- Hayes BT, Sabado A, Minami H, Zhang C, Holm M, Khalid L, Lu TY, Torres-Lockhart K, Fox AD. MiBUP: A pilot randomized controlled trial of low-dose initiation of buprenorphine for opioid use disorder: Design and rationale. Contemp Clin Trials Commun. 2026 Jan 5;49:101594. doi: 10.1016/j.conctc.2026.101594. eCollection 2026 Feb. PMID 41567709
Identifiers
NCT: NCT05450718 · 2022-14185 · 1K23DA055933