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Opioid Partial Agonist

extended-release buprenorphine (BXR) for Opioid Use Disorder

Phase 2
Waitlist Available
Led By frances r levin, md
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights

Study Summary

This trial is testing to see if an injectable extended-release form of buprenorphine (Sublocade) is more helpful than the standard sublingual buprenorphine therapy in treating opiate use for individuals testing positive for fentanyl and related high potency drugs (HPSO).

Eligible Conditions
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Days of opioid use per week

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: extended-release buprenorphine (BXR)Experimental Treatment1 Intervention
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.
Group II: sublingual buprenorphine (BSL)Active Control1 Intervention
sublingual buprenorphine (BSL) up to 24 mg will be administered once daily for 12 weeks or length of study participation.

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,867 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,593 Total Patients Enrolled
frances r levin, mdPrincipal InvestigatorNew York State Psychiatric Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned the utilization of extended-release buprenorphine (BXR)?

"Assigned a score of 2, our team at Power believes that extended-release buprenorphine (BXR) is safe. This rating reflects the fact that while there are data indicating its safety, none regarding efficacy has been collected yet as it is only in phase 2 trials."

Answered by AI

Is this experiment still accepting participants?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical research is recruiting patients since being initially posted in December 15th 2020 and last updated on September 29th 2022. The target number of participants needed are 40 people from a single site."

Answered by AI

Does the age criterion for this trial encompass individuals under 75 years old?

"This trial is open to individuals aged 18-65. Clinical trials for those younger than 18 number 330, and there are 955 studies available for persons above the age of 65."

Answered by AI

How many individuals are currently partaking in the experiment?

"Affirmative. Data on clinicaltrials.gov indicates that this medical experiment, which was started on December 15th 2020, is actively seeking participants. Currently they are recruiting 40 patients from one centre."

Answered by AI

To whom does this medical research offer enrollment?

"To be eligible for this clinical trial, patients must suffer from the specified disease and fall between 18-65 years old. The team is currently recruiting up to 40 individuals."

Answered by AI

Is there a history of research into the sustained-release format for buprenorphine (BXR)?

"Currently, there are 11 Phase 3 studies concerning extended-release buprenorphine (BXR) with 40 more still in progress. Although most of these trials are occuring within Durham, North carolina, an additional 220 sites have been selected to research the medication."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Been taking zubsolv one a day for a year.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder
Frances R Levin 2020. "Extended-Release Buprenorphine vs. Sublingual Buprenorphine for the Treatment of Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04352166.
~7 spots leftby Dec 2024
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