Low-dose Buprenorphine Initiation for Opioid Use Disorder

Montefiore Medicine Academic Health System

Status and phase: Enrolling; Phase 4

Conditions: Opioid Use Disorder

Treatments: Drug: buprenorphine-naloxone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05450718

1K23DA055933 (U.S. NIH Grant/Contract)

2022-14185

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Low-dose initiation

Experimental group

Description:

Participants randomized to low-dose buprenorphine initiation will start low-dose buprenorphine-naloxone (bup-nx) according to an at-home, 8-day protocol (below). Participants in the low-dose buprenorphine initiation arm will be allowed to continue taking the full opioid agonist that they were taking at the time of enrollment until they reach a therapeutic dose of buprenorphine-naloxone. Day 1: 0.5 mg once; Day 2: 0.5 mg every 12 hours; Day 3: 1 mg every 12 hours; Day 4: 2 mg every 12 hours; Day 5: 3mg every 12 hours; Day 6: 4 mg every 12 hours; Day 7: 6 mg every 12 hours; Day 8: 8 mg every 12 hours

Treatment:

Drug: buprenorphine-naloxone

Drug: buprenorphine-naloxone

Treatment as usual

Active Comparator group

Description:

Participants randomized to treatment as usual will start buprenorphine-naloxone (bup-nx) following standard clinical guidelines for two-day, at-home initiation.

Treatment:

Drug: buprenorphine-naloxone

Drug: buprenorphine-naloxone