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Opioid Partial Agonist

Extended Release Buprenorphine for Opioid Use Disorder (EXHITENTRE Trial)

Phase 2 & 3
Recruiting
Led By Gavin Bart, MD,PhD
Research Sponsored by Hennepin Healthcare Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age
Willing to initiate MOUD, including buprenorphine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 34, 90 and 180 post hospital discharge
Awards & highlights

EXHITENTRE Trial Summary

This trial is testing whether a 28-day formulation of extended-release buprenorphine is more effective than usual treatment for patients with a moderate or severe opioid use disorder who are seen by an addiction consultation service and agree to start a medication for OUD.

Who is the study for?
This trial is for adults over 18 with moderate or severe opioid use disorder who are hospitalized and willing to start medication treatment. They must speak English well enough for consent and not have serious medical conditions that could interfere with the study or make it unsafe.Check my eligibility
What is being tested?
The study compares a new 28-day extended-release buprenorphine (XR-BUP) with usual treatments in patients seen by an addiction service at the hospital. Participants will be randomly assigned to either XR-BUP or standard care before leaving the hospital, followed up after discharge.See study design
What are the potential side effects?
Extended-release buprenorphine may cause side effects like nausea, headache, sweating, constipation, insomnia, pain at injection site, and possible allergic reactions. The severity of side effects can vary from person to person.

EXHITENTRE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am willing to start medication-assisted treatment, including buprenorphine.
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I am currently in the hospital.

EXHITENTRE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 34, 90 and 180 post hospital discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 34, 90 and 180 post hospital discharge for reporting.

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 OUD care on the 34th day following hospital discharge.
Secondary outcome measures
Proportion of participants engaged with MOUD
Proportion of participants that experience Adverse Events (AE)
Proportion of participants with positive urine drug test
+3 more

EXHITENTRE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionalExperimental Treatment1 Intervention
Single subcutaneous injection of a 28-day formulation of extended-release buprenorphine within 72 hours of anticipated hospital discharge.
Group II: Treatment as UsualActive Control1 Intervention
Community standard of care that includes initiation of either methadone, sublingual (SL) buprenorphine, or naltrexone prior to hospital discharge.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,455 Previous Clinical Trials
2,596,622 Total Patients Enrolled
The Emmes Company, LLCIndustry Sponsor
145 Previous Clinical Trials
1,051,149 Total Patients Enrolled
Hennepin Healthcare Research InstituteLead Sponsor
90 Previous Clinical Trials
76,835 Total Patients Enrolled

Media Library

Extended Release Buprenorphine (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04345718 — Phase 2 & 3
Substance Use Disorder Research Study Groups: Treatment as Usual, Interventional
Substance Use Disorder Clinical Trial 2023: Extended Release Buprenorphine Highlights & Side Effects. Trial Name: NCT04345718 — Phase 2 & 3
Extended Release Buprenorphine (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04345718 — Phase 2 & 3

Frequently Asked Questions

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

Are there any other instances where Extended Release Buprenorphine has been studied?

"Originally, extended release buprenorphine was trialled at Shalvata Medical Health Center back in 2012. So far, there have been a total of 297 completed studies. Right now, there are 45 active trials with a significant portion of these taking place in Baltimore, Maryland."

Answered by AI

Are patients being sought for this treatment program at the moment?

"Yes, this information is accurate. The study in question is still recruiting patients, as shown by the listing on clinicaltrials.gov. This particular trial was posted on August 9th, 2021 and was last edited on May 10th, 2022."

Answered by AI

Could you please tell me how many facilities are testing this new treatment?

"At the moment, this study is enrolling patients that go to Massachusetts General Hospital, Johns Hopkins Bayview Medical Center, and Hennepin Healthcare Research Institute. There are also 5 other recruitment centres."

Answered by AI
Recent research and studies
~138 spots leftby Jan 2026