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Clinical trialNCT04352166SuspendedPhase 2Interventional

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

SponsorFrances R LevinEnrollment40Opioid-use Disorder
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Nyspi-Stars

    New York, New York, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Extended-release buprenorphineSublingual buprenorphine
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
15 Dec 2020
Primary completion
30 Jun 2025
Completion
30 Jun 2025
Last update posted
14 Feb 2025
Registered enrollment
40
Registry id
NCT04352166
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.