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Opioid Agonist
Integrated Opioid Addiction Care for Opioid Addiction (HEROES Trial)
Phase 4
Waitlist Available
Led By James R Langabeer, EMT, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after induction in the emergency department
Awards & highlights
HEROES Trial Summary
This trial is testing a new approach to treating opioid addiction that integrates different types of care and follow-up.
Who is the study for?
This trial is for individuals who have tested positive for opioid use, can communicate in English, are willing to quit opioids, and meet the criteria for opioid dependence. They must be in good health overall and able to consent to the study. Pregnant or nursing women, those with severe other drug dependencies needing immediate treatment, or serious medical conditions like unstable heart disease are excluded.Check my eligibility
What is being tested?
The HEROES program aims to help people with opioid addiction by combining medication-assisted treatment (Suboxone), counseling right after an emergency visit, outpatient referrals, coaching support from peers who've recovered from addiction themselves, and follow-up care from paramedics.See study design
What are the potential side effects?
Suboxone may cause side effects such as nausea, vomiting, drug withdrawal syndrome, headache, sweating, numb mouth feeling due to naloxone when injected intravenously instead of taken by mouth as prescribed.
HEROES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at the time of enrollment in outpatient treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of enrollment in outpatient treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient enrollment in outpatient treatment
Patient retention in outpatient treatment
HEROES Trial Design
1Treatment groups
Experimental Treatment
Group I: Suboxone induction into MAT in the EDExperimental Treatment4 Interventions
Suboxone induction into medication-assisted treatment (MAT) in the emergency department (ED)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Suboxone
2008
Completed Phase 3
~290
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
319,477 Total Patients Enrolled
James R Langabeer, EMT, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to stop using opioids.I do not speak English.I am currently pregnant or nursing.I am not severely depressed, acutely psychotic, or at immediate risk of suicide.I am willing and able to sign the consent form.I do not have any unstable health conditions like heart disease or liver problems.
Research Study Groups:
This trial has the following groups:- Group 1: Suboxone induction into MAT in the ED
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT03396276 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate of individuals who are participating in this medical experiment?
"Affirmative. Clinicaltrials.gov corroborates that this clinical trial is presently accepting applicants, the initial post date being April 1st 2018 and last updated on May 17th 2022. This research project requires 250 test subjects to be enrolled from a single location."
Answered by AI
What hazards are associated with referring patients to outpatient treatment?
"The safety of referral to outpatient treatment is judged as a 3, since it has already been approved by regulatory bodies and entered Phase 4 trials."
Answered by AI
Is the recruitment phase of this study still open?
"Affirmative. Clinicaltrials.gov data corroborates that this clinical research initiative, which was first publicized on April 1st 2018, is still recruiting patients. Approximately 250 subjects are needed to be enrolled from a single hospital site."
Answered by AI
Are there historical precedents of referring patients to out-patient care through clinical trials?
"Presently, 56 clinical trials are examining the effects of Referral to outpatient treatment. These studies range from Phase 3 and 235 locations across multiple states have been identified as operating sites for these investigations. The greatest concentration is found in White River Junction, Vermont where 13 active trials are being conducted."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
The University of Texas Health Science Center at Houston
How many prior treatments have patients received?
2
Why did patients apply to this trial?
I am currently taking suboxone, while I have been able to stay sober I know the chances of relapse and possible overdosing is higher for someone like me. I really want to help this specific study because I believe if we can treat opioid addiction in the ED it would save lives.
PatientReceived 2+ prior treatments
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