NCT05450718

Low-dose Buprenorphine Initiation for Opioid Use Disorder

A Pilot Randomized Controlled Trial of Low-dose Buprenorphine Initiation for Opioid Use Disorder

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	buprenorphine-naloxone	Low-dose initiation of buprenorphine-naloxone protocol
DRUG	buprenorphine-naloxone	Standard clinical guidelines for a two-day buprenorphine-naloxone initiation

Timeline

• Start date: 2024-11-11
• Primary completion: 2027-03-17
• Completion: 2027-06-30
• First posted: 2022-07-11
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study