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

NCT04352166 | Suspended Phase 2 FDA Drug

• 2 other identifiers: 7963R21DA049037
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid-use Disorder

Keywords

opioid use disorder; fentanyl; treatment; Sublocade

Outcome Measures

Primary Outcomes (1)

• Days of opioid use per week

  Days of opioid use per week as measured by the timeline follow-back method and confirmed by urine toxicology.

  up to 12 weeks

Study Arms (2)

extended-release buprenorphine (BXR)

EXPERIMENTAL

Three extended-release buprenorphine (BXR) injections to be administered roughly 28 days apart. The first and second injection will be 300 mg and the third will be 100 mg.

Drug: extended-release buprenorphine (BXR)

sublingual buprenorphine (BSL)

ACTIVE COMPARATOR

sublingual buprenorphine (BSL) up to 24 mg will be administered once daily for 12 weeks or length of study participation.

Drug: sublingual buprenorphine (BSL)

Interventions

extended-release buprenorphine (BXR) DRUG

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

Also known as: Sublocade

extended-release buprenorphine (BXR)

sublingual buprenorphine (BSL) DRUG

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

Also known as: buprenorphine

sublingual buprenorphine (BSL)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals between the age of 18-65
• Voluntarily seeking treatment for opioid use
• Meets current DSM-5 criteria for Opioid Use Disorder as a primary diagnosis, with at least moderate severity
• Test positive for high potent synthetic opioids (HPSO) use
• Able to provide informed consent and comply with study procedures

You may not qualify if:

• Meets DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis
• Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as an active psychotic disorder or current suicide risk
• Methadone maintenance treatment within the past 30 days
• Buprenorphine maintenance treatment within the past 30 days
• Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)
• Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients; male participants are required to use adequate forms of birth control as the exposure to sublocade on sperm and subsequent fetal development are not known
• Unstable medical conditions, which might make participation hazardous such as uncontrolled hypertension (blood pressure \>150/100), acute hepatitis, uncontrolled diabetes, or elevated liver function tests (AST and ALT \>3 times the upper limit of normal
• Legally mandated to substance use disorder treatment
• Individuals, who in the clinicians judgment, have a history of failed trial of buprenorphine or sublocade (e.g., history of severe opioid intoxication or overdoses despite adequate adherence to buprenorphine or sublocade), or other features of the history strongly suggest the patient is not a good candidate for outpatient treatment with buprenorphine.

Sponsors & Collaborators

• Frances R Levin: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Nyspi-Stars

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Sublocade; Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• frances r levin, md

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Psychiatrist

Model Details: Two arm, randomized (1:1 allotment), open-label trial

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: December 15, 2020
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: beginning twelve months and ending 5 years after article publication
• Access Criteria: to researcher who provides a methodologically sound proposal to achieve aims in approved proposal

Locations

US (1)