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Opioid Agonist

Buprenorphine for Opioid Use Disorder (ED-ENVISION Trial)

Phase 3
Waitlist Available
Led By Kathryn Hawk
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be 18 years or older
Be older than 18 years old
Must not have
Require ongoing prescription for opioid analgesics
Have a medical or psychiatric condition that requires hospitalization at the time of index ED visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured daily for 10 days post randomization
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is looking at two different methods to treat opioid use disorder in emergency department patients. They want to see if a standard dose or a high dose induction method leads to more patients seeking treatment within

Who is the study for?
This trial is for adults over 18 with moderate to severe opioid use disorder (OUD), who have tested positive for opioids and are not currently on opioid withdrawal treatments. Participants must speak English, be able to consent, and commit to the study's follow-up process. Those with ongoing opioid prescriptions, prior study enrollment, in custody, or with conditions needing hospitalization can't join.
What is being tested?
The trial compares two methods of starting Buprenorphine treatment in emergency department patients: a Standard Dose Induction (SDI) versus a High Dose Induction (HDI). It aims to see which method leads to better engagement in OUD treatment after discharge and assesses withdrawal symptoms and drug cravings.
What are the potential side effects?
Buprenorphine may cause side effects like nausea, drowsiness, constipation, headache, sweating, decreased libido or respiratory issues. The high dose induction being tested could potentially amplify these effects.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need a prescription for painkillers.
Select...
I was hospitalized for a medical or psychiatric condition when I first visited the emergency department.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 10 days after study randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 10 days after study randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Engagement in Treatment (10)
Secondary study objectives
Craving
Engagement in Treatment (30)
Substance Use
+1 more

Side effects data

From 2014 Phase 3 trial • 815 Patients • NCT01675167
17%
Nausea
8%
Constipation
7%
Vomiting
7%
Headache
5%
Dizziness
5%
Somnolence
1%
Drug withdrawal syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
OL Buprenorphine HCl Buccal Film
DB Buprenorphine HCl Buccal Film
DB Placebo Film

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 Dose SL-BUPExperimental Treatment1 Intervention
Participants will receive three 5.7 mg Zubsolv pills; all will be active medication.
Group II: Standard SL-BUPActive Control1 Intervention
Participants will receive three pills; one 5.7 mg Zubsolv pill with active medication and two placebo pills.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buprenorphine
2014
Completed Phase 4
~2600

Find a Location

Who is running the clinical trial?

The Emmes Company, LLCIndustry Sponsor
147 Previous Clinical Trials
1,051,778 Total Patients Enrolled
Alameda Health SystemOTHER
6 Previous Clinical Trials
2,966 Total Patients Enrolled
Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,098 Total Patients Enrolled
National Drug Abuse Treatment Clinical Trials NetworkNETWORK
6 Previous Clinical Trials
2,612 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,575 Total Patients Enrolled
Kathryn HawkPrincipal InvestigatorYale University
Gail D'Onofrio, MD, MSPrincipal InvestigatorYale University
5 Previous Clinical Trials
5,460 Total Patients Enrolled
~240 spots leftby Apr 2027
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