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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
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Recruitment Feasibility: Percentage of subjects assessed who enroll in the clinical trial.
Secondary study objectives
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 study objectives
Anxiety severity at 1 week
Buprenorphine treatment uptake, clinical visit
Buprenorphine-naloxone (bup-nx) Dose per day
+16 moreAwards & Highlights
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.
Trial 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 buprenorphine 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
457 Previous Clinical Trials
588,551 Total Patients Enrolled
Benjamin T Hayes, MD, MS, MPHPrincipal InvestigatorMontefiore Medical Center
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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.
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