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Behavioral Intervention
Naloxone + Buprenorphine Induction for Opioid Use Disorder (NBIM Trial)
Phase 3
Recruiting
Led By Cecilia Bergeria, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years or older
Provides urine sample that tests positive for fentanyl
Must not have
Adverse cardiovascular event in the past three years (e.g. significant cardiac arrhythmia, myocardiac infarction, endocarditis)
Significant cognitive impairment resulting in inability to provide informed consent (e.g., severe dementia or intellectual disability)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after initial buprenorphine dose up to 24 hours
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial will assess a new method to rapidly transition people with chronic opioid use to treatment, using naloxone & buprenorphine, to help combat the opioid epidemic.
Who is the study for?
This trial is for adults over 18 who speak English, have a moderate to severe opioid use disorder with fentanyl present in their urine, and are medically cleared to take the study medication. They must be willing to follow the study protocol but not currently on medications for OUD or pregnant/breastfeeding.
What is being tested?
The trial tests a new method of starting buprenorphine treatment using naloxone nasal spray among individuals who use fentanyl. It aims to see if this approach can safely and quickly transition patients without prolonged withdrawal by gradually increasing buprenorphine doses.
What are the potential side effects?
Potential side effects may include typical reactions associated with naloxone such as body aches, diarrhea, rapid heart rate, fever, sneezing, goosebumps, weakness and changes in blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My urine test was positive for fentanyl.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a serious heart problem in the last 3 years.
Select...
I am able to understand and consent to my treatment.
Select...
My blood pressure is between 90/60 and 140/90.
Select...
I am currently receiving medication for opioid use disorder.
Select...
I am not on any medication that conflicts with the study drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after initial buprenorphine dose up to 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after initial buprenorphine dose up to 24 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Length of time (hours) for participants to reach 8mg of buprenorphine
Peak opioid withdrawal as assessed by the Subjective Opiate Withdrawal Scale (SOWS)
Self-report acceptability
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: 8mg buprenorphineExperimental Treatment1 Intervention
8mg of buprenorphine will be given to a subset of participants immediately after naloxone administration.
Group II: 4mg buprenorphineExperimental Treatment1 Intervention
4mg of buprenorphine will be given to a subset of participants immediately after naloxone administration.
Group III: 24mg buprenorphineExperimental Treatment1 Intervention
24mg of buprenorphine will be given to a subset of participants immediately after naloxone administration.
Group IV: 16mg buprenorphineExperimental Treatment1 Intervention
16mg of buprenorphine will be given to a subset of participants immediately after naloxone administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naloxone Nasal Spray
2021
Completed Phase 1
~80
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,741 Total Patients Enrolled
Cure Addiction NowUNKNOWN
Cecilia Bergeria, PhDPrincipal InvestigatorJohns Hopkins School of Medicine
1 Previous Clinical Trials
30 Total Patients Enrolled