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Opioid Partial Agonist
High Dose Buprenorphine for Opioid Use Disorder
Phase 3
Recruiting
Led By Ethan Cowan, MD, MS
Research Sponsored by Icahn School of Medicine at Mount Sinai
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 240 minutes
Awards & highlights
Study Summary
This trial tests if a higher buprenorphine dose is safe & can increase engagement in addiction services.
Who is the study for?
This trial is for adults in the emergency department with moderate to severe opioid use disorder, showing withdrawal symptoms and a positive test for fentanyl. They must understand the study and agree to participate. Excluded are those with legal issues, no additional contact point, unwillingness to follow procedures, recent naloxone use, pain management opioids need, methadone presence in tests, pregnancy, unstable conditions requiring hospitalization or current/formal addiction treatment.Check my eligibility
What is being tested?
The trial compares two doses of Buprenorphine: a standard dose (12mg) versus a high dose (32mg), which can be reduced to 24mg if necessary. The goal is to see if higher doses are safe and increase engagement in addiction treatment after one week. It includes an initial head-to-head comparison followed by a small pilot randomized double-blinded trial.See study design
What are the potential side effects?
Potential side effects of Buprenorphine may include nausea, vomiting, dizziness, constipation or headaches. High doses could potentially amplify these effects but this will be closely monitored during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 240 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 240 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of participants engaged in comprehensive addiction treatment at 7-days post-ED induction
Secondary outcome measures
Opioids
Change in number of times opioids used (Trial 2)
Daily assessment of opioid use (Trial 1)
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Buprenorphine High DoseExperimental Treatment1 Intervention
The experimental arm tests the safety and tolerability of 32mg of BUP split as 16mg at time=0 and 16mg at time=30-60 min as an induction dose.
Group II: Buprenorphine Standard DoseActive Control1 Intervention
The standard arm will receive an induction dose of 12mg of buprenorphine (BUP) split as 8mg at time=0 and 4mg at time=30-60 min.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
867 Previous Clinical Trials
526,777 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,479 Previous Clinical Trials
2,620,761 Total Patients Enrolled
Ethan Cowan, MD, MSPrincipal InvestigatorIcahn School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My drug screen tested positive for methadone.I need opioids regularly for pain management.I was given naloxone within an hour before my first TM BUP dose.I was treated in the emergency department during the study's screening hours.I do not have any unstable health or mental conditions needing hospital care.
Research Study Groups:
This trial has the following groups:- Group 1: Buprenorphine Standard Dose
- Group 2: Buprenorphine High Dose
Awards:
This trial has 2 awards, including:- 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.
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.
Are new participants needed for this ongoing research project?
"The clinical trial in question, which was created on 1/1/2023, is not presently recruiting patients according to the clinicaltrials.gov website. The site was last updated on 10/20/2022. There are 496 other trials that are recruiting patients."
Answered by AI
What is the potential severity of Buprenorphine High Dose for patients?
"Buprenorphine High Dose received a safety score of 3 because there is clinical data affirming its efficacy and multiple rounds of safety data."
Answered by AI
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