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COMPLETED
NCT04352166
PHASE2

Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder

Sponsor: Frances R Levin

View on ClinicalTrials.gov

Summary

The study is 12-week, randomized, open-label study comparing injectable extended-release buprenorphine (Sublocade) to standard therapy (sublingual buprenorphine), to see if Sublocade will be more helpful in treating opiate use for individuals testing positive for fentanyl and related high potency drugs (HPSO). Those receiving Sublocade will have it administered monthly and dosing will be according to the FDA prescribing instructions of 300mg for the first and second dose and 100mg for the third. Individuals receiving sublingual buprenorphine will receive standard dosing for the entire treatment trial. Participants will be asked to attend the clinic for the first 4 days during week 1 and twice weekly for the remainder of the trial.

Official title: Randomized Controlled Trial of Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder Patients Using Fentanyl

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2020-12-15

Completion Date

2023-08-08

Last Updated

2026-08-27

Healthy Volunteers

No

Interventions

DRUG

extended-release buprenorphine (BXR)

Three monthly injections will be provided during the course of the 12 week trial.

DRUG

sublingual buprenorphine (BSL)

On a weekly basis patients will be provided with sublingual buprenorphine to take up to 24 mg daily.

Locations (1)

Nyspi-Stars

New York, New York, United States