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High vs Low Intensity Treatment Strategies for Opioid Addiction (EXHITENTRE Trial)
N/A
Recruiting
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
Provide inpatient general medical care
Must not have
Have an existing, functioning HBOT program or be imminently starting an HBOT initiative
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 34 days following hospital discharge
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two different strategies for implementing medication-based treatment for opioid addiction in community hospitals.
Who is the study for?
This trial is for community hospitals that want to start treating opioid use disorder (OUD) in hospitalized patients. Hospitals must be willing to adopt new treatment strategies, have staff trained, and work with a site champion. They should not already have an opioid treatment program or be a Veterans Affairs hospital.
What is being tested?
The study compares two methods of implementing hospital-based opioid use disorder treatments: one with low-intensity support and another with high-intensity support. It aims to see which strategy better supports the adoption of medication treatments for OUD in community hospitals.
What are the potential side effects?
Since this trial focuses on implementation strategies rather than direct patient interventions, it does not directly involve side effects related to medications or treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am receiving general medical care as a hospital inpatient.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am part of or about to start a hyperbaric oxygen therapy program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 34 days following hospital discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~34 days following hospital discharge
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Engagement with MOUD
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: High IntensityExperimental Treatment1 Intervention
MOUD training and support through the use of educational materials in addition to practice facilitation.
Group II: Low IntensityActive Control1 Intervention
MOUD training and support through the use of educational materials.
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Who is running the clinical trial?
Hennepin Healthcare Research InstituteLead Sponsor
92 Previous Clinical Trials
77,473 Total Patients Enrolled
The Emmes Company, LLCIndustry Sponsor
147 Previous Clinical Trials
1,052,114 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,587 Previous Clinical Trials
3,328,524 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am open to any level of support during the trial.I am open to any level of support during the trial.My hospital is willing to start medication for opioid use disorder before I leave.I can ensure access to a prescriber for post-discharge opioid use disorder treatment.I am receiving general medical care as a hospital inpatient.My hospital is willing to start medication-assisted treatment before I leave.I am part of or about to start a hyperbaric oxygen therapy program.My Medicaid records show at least 3 diagnoses and outpatient treatment details, updated within the last year.I have a doctor ready to prescribe buprenorphine for my opioid use disorder after I leave the hospital.You are willing to identify a site champion to promote and adopt change that can address OUD in hospitalized patients.You are a patient of a community hospital in the region of a site/hub.You are willing to be trained and to collect data for the site/hub team.
Research Study Groups:
This trial has the following groups:- Group 1: Low Intensity
- Group 2: High Intensity
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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