NCT05944952

Low-dose Versus a High-dose Sublingual Buprenorphine Induction

A Pilot Study Comparing a Low-dose Versus a High-dose Sublingual Buprenorphine Induction Dosing Scheme in Fentanyl Using Patients With Opioid Use Disorder (OUD)

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Friends Research Institute, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study proposes to compare a low-dose versus a high-dose buprenorphine induction scheme in 40 fentanyl using people with Opioid Use Disorder (OUD). Study participants will be randomized to either the low-dose (n=20) or high dose (n=20) group and dispensed medication daily for one week.

Detailed description

This study proposes to compare a low-dose versus a high-dose buprenorphine induction scheme in 40 fentanyl using people with Opioid Use Disorder (OUD). Study participants will be randomized to either the low-dose (n=20) or high dose (n=20) group and dispensed medication daily for one week. Thereafter, they will be treated according to the MATClinics usual schedule of clinic visits. The number and timing of visits may vary according to whether the participant is still using illicit opioids. Follow-up visits for the study will be at one and three months.The primary objective is to determine whether patients randomly assigned to low versus high dose induction regimens are more likely to complete the 7-day induction period. Secondary outcomes are the number of patients who develop precipitated withdrawal or other adverse events, experience subjective opioid withdrawal symptoms, use adjunctive medications (hydroxyzine, loperamide, dicyclomine, clonidine, ibuprofen, methocarbamol, trazodone, ondansetron) provided by the clinic, recommendation of the medication induction scheme to other patients, and treatment retention at 1- and 3- months post induction.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	buprenorphine/naloxone	Participants will be dosed with buprenorphine/ naloxone strips

Timeline

• Start date: 2024-06-20
• Primary completion: 2024-12-31
• Completion: 2025-10-30
• First posted: 2023-07-14
• Last updated: 2025-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study