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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
Must not have
Severe alcohol or benzodiazepine use disorder that is anticipated to require complex medical detoxification which cannot be completed prior to randomization
Disabling terminal diagnosis for which hospice care is being sought
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 34, 90 and 180 post hospital discharge
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a severe alcohol or benzodiazepine addiction that can't be treated quickly.
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I am seeking hospice care for a terminal illness.
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My liver tests are very high or I have chronic severe liver disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of participants engaged in OUD care on the 34th day following hospital discharge.
Secondary study objectives
Proportion of participants engaged with MOUD
Proportion of participants that experience Adverse Events (AE)
Proportion of participants with positive urine drug test

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,605 Previous Clinical Trials
3,329,576 Total Patients Enrolled
The Emmes Company, LLCIndustry Sponsor
147 Previous Clinical Trials
1,051,796 Total Patients Enrolled
Hennepin Healthcare Research InstituteLead Sponsor
92 Previous Clinical Trials
76,851 Total Patients Enrolled
Gavin Bart, MD,PhDPrincipal InvestigatorHennepin Heatlhcare

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
~79 spots leftby Jan 2026
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