← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after initial buprenorphine dose up to 24 hours

Awards & highlights

NBIM Trial 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.Check my eligibility

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.See study design

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.

NBIM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My urine test was positive for fentanyl.

NBIM Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and after initial buprenorphine dose up to 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Side effects data

From 2017 Phase 4 trial • 570 Patients • NCT02032433

13%

Gastrointestinal

10%

Psychiatric

10%

Nervous system disorders

Infections and infestations

Injury, poisoning and procedural complications

Injury poisoning and procedural complications

Musculoskeletal and connective tissue disorders

General Disorders and Administration Site Conditions

Investigations

Skin and subcutaneous tissue disorders

Respiratory, thoracic, and mediastinal disorders

Metabolism and nutrition

Eye disorders

Respiratory, thoracic and mediastinal disorders

Renal and urinary disorders

Reproductive system and breast disorders

General disorders and administration site conditions

100%

80%

60%

40%

20%

Study treatment Arm

Extended-Release Naltrexone

Buprenorphine-Naloxone

NBIM 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,472 Total Patients Enrolled

Cure Addiction NowUNKNOWN

Cecilia Bergeria, PhDPrincipal InvestigatorJohns Hopkins School of Medicine

1 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

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

Are there any safety issues associated with administering 4mg buprenorphine to patients?

"Our team has determined that 4mg buprenorphine is likely safe, as evidenced by the Phase 3 rating of 3. This indicates there are already studies demonstrating its effectiveness and multiple trials showcasing safety results."

Answered by AI

Are there any available vacancies in this clinical investigation?

"The information on clinicaltrials.gov suggests that this particular trial is not currently accepting enrolment; the first post date was January 15th 2024 and its last update took place October 13th 2023. However, there are 282 other active studies seeking patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl

2024. "Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06089707.

All > Probuphine