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Opioid Partial Agonist
Low-Dose Buprenorphine for Opioid Use Disorder
Phase 4
Recruiting
Led By Benjamin T Hayes, MD, MS, MPH
Research Sponsored by Montefiore Medical Center
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 at baseline study visit (time zero)
Awards & highlights
Study Summary
This trial will test whether low-dose buprenorphine is safe and effective in treating opioid use disorder.
Who is the study for?
Adults over 18 with opioid use disorder who are willing to follow study procedures and can take sublingual medication. They must not be pregnant, lactating, or have cognitive impairments that prevent consent. Participants should not be on other FDA-approved medications for opioid use disorder or have severe mental illness.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of starting treatment for opioid addiction with a low dose of buprenorphine-naloxone. The goal is to see if this approach helps people manage their condition better than current methods.See study design
What are the potential side effects?
Buprenorphine-naloxone may cause side effects like nausea, headaches, drowsiness, sweating, constipation, and possible allergic reactions in those sensitive to its components.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial.
Secondary outcome measures
Non-prescribed opioid use
Number of participants retained in buprenorphine treatment at 6 weeks
Number of participants who uptake buprenorphine treatment at 2 weeks
+3 moreOther outcome measures
Anxiety severity at 1 week
Buprenorphine treatment uptake, clinical visit
Buprenorphine-naloxone (bup-nx) Dose per day
+16 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Low-dose initiationExperimental Treatment1 Intervention
Participants randomized to low-dose buprenorphine initiation will start low-dose buprenorphine-naloxone (bup-nx) according to an at-home, 8-day protocol (below). Participants in the low-dose BUP initiation arm will be allowed to continue taking the full opioid agonist that they were taking at the time of enrollment until they reach a therapeutic dose of buprenorphine-naloxone.
Day 1: 0.5 mg once; Day 2: 0.5 mg every 12 hours; Day 3: 1 mg every 12 hours; Day 4: 2 mg every 12 hours; Day 5: 3mg every 12 hours; Day 6: 4 mg every 12 hours; Day 7: 6 mg every 12 hours; Day 8: 8 mg every 12 hours
Group II: Treatment as usualActive Control1 Intervention
Participants randomized to treatment as usual will start buprenorphine-naloxone (bup-nx) following standard clinical guidelines for two-day, at-home initiation.
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
442 Previous Clinical Trials
582,456 Total Patients Enrolled
Benjamin T Hayes, MD, MS, MPHPrincipal InvestigatorMontefiore Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fluent in English or Spanish.I can take medicine under my tongue.I have taken FDA-approved opioid addiction treatments in the last 14 days.You have a problem with using opioid drugs as determined by specific guidelines.I am allergic to buprenorphine or naloxone.I cannot give consent because of cognitive issues.I can fluently speak English or Spanish.I am 18 years old or older.I am 18 years old or older.You have an addiction to opioids according to the DSM-V criteria.You are currently using illegal drugs called opioids.I am willing to try a new low-dose treatment or the usual approach.
Research Study Groups:
This trial has the following groups:- Group 1: Low-dose initiation
- Group 2: Treatment as usual
Awards:
This trial has 5 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks do individuals face when taking buprenorphine-naloxone?
"The safety of buprenorphine-naloxone is rated at 3, as it has received approval after the fourth stage of clinical trials."
Answered by AI
Are there any opportunities to join this clinical trial at present?
"Clinicaltrials.gov information indicates that this study, which was initially made available on August 1st 2023 and last updated November 28th 2022, is no longer actively recruiting participants. However, 1339 other trials are presently looking for candidates to join them in their research endeavors."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
Montefiore Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Montefiore Medical Center: < 48 hours
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