Low-dose Buprenorphine Initiation for Opioid Use Disorder

Phase 4RecruitingNCT05450718

Montefiore Medical Center70 enrolled

Overview

The purpose of this study is to test whether low-dose buprenorphine initiation for treatment of opioid use disorder is safe and effective.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Opioid Use Disorder

Interventions

buprenorphine-naloxoneDRUG

Low-dose initiation of buprenorphine-naloxone protocol

buprenorphine-naloxoneDRUG

Standard clinical guidelines for a two-day buprenorphine-naloxone initiation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Any gender, aged 18 years or greater 4. Opioid Use Disorder (based on Diagnostic and Statistical Manual- Version 5 criteria) 5. Ability to take sublingual medication 6. Willingness to adhere to the assigned buprenorphine initiation regimen 7. Fluency in English or Spanish 8. For participants of reproductive potential: agreement to use highly effective contraception during study participation Exclusion Criteria: 1. Use of FDA-approved medications for opioid use disorder treatment (within 7 days prior to screening), including methadone, buprenorphine, or naltrexone 2. Diagnosis of Alcohol Use Disorder, severe or Benzodiazepine Use Disorder, severe (based on Diagnostic and Statistical Manual- Version 5 criteria) 3. Severe untreated mental illness, meaning psychosis or suicidality 4. Presence of an acute or chronic medical condition that would make participation medically hazardous 5. Pregnancy or lactation 6. Known allergic reactions to buprenorphine or naloxone 7. Inability to consent due to cognitive impairment

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States

RECRUITING

Outcomes

Primary Outcomes

Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial.

This pilot study is designed to establish the feasibility of a future, full-powered clinical trial. The primary question this study seeks to answer is whether primary care patients with opioid use disorder are willing to enroll in a clinical trial of low-dose inductions. The study will aim to enroll 25% of subjects who are assessed. "Assessed" is defined as having been referred to the study staff. Enrollment is defined as having been randomized to a treatment arm.

Time frame: At baseline study visit (time zero)

Secondary Outcomes

Protocol Feasibility: Proportion of participants who follow adequate fidelity to the low-dose initiation study protocol.

This pilot study will seek to answer whether participants of a clinical trial adhere to a low-dose buprenorphine-naloxone (bup-nx) initiation protocol. The study aims to achieve 80% of study participants meeting adequate fidelity to the low-dose study protocol. Adequate fidelity is defined as meeting all of the following: 1. First dose is a low dose (defined as less than 1-.25mg bup-nx) (yes/no), 2. Daily bup-nx dose equivalent to assigned daily dose: For the first 7 days the reported total daily bup-nx dose is within the prespecified assigned daily dose limit, 3. Variability: Each day's daily dose is increased from the prior daily dose (within daily limits) (yes/no). Measured using once daily participant self-report through mobile data collection technology.

Time frame: From baseline to day 8

Number of participants who uptake buprenorphine treatment at 2 weeks

Uptake is defined as having a positive urine drug test (UDT) for buprenorphine at the 2-week study visit (dichotomous, yes/no).

Time frame: 2-week study visit

Number of participants retained in buprenorphine treatment at 6 weeks

6-week retention is defined as having an active buprenorphine prescription and buprenorphine-positive UDT at the 6-week visit

Central Contacts

Benjamin T Hayes, MD, MS, MPH

CONTACT

4156700850 bhayes@montefiore.org

Data from ClinicalTrials.gov

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