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Opioid Agonist

High Dose SL-BUP for Opioid Use Disorder (ED-ENVISION Trial)

Phase 3
Waitlist Available
Led By Gail D'Onofrio, MD, MS
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Be 18 years or older.
2. Be treated in the ED during study screening hours.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured daily for 10 days post randomization
Awards & highlights

Summary

This study is a multisite double-blind, double-dummy, randomized clinical trial enrolling ED patients with untreated moderate to severe opioid use disorder (OUD) to compare Standard Dose Induction (SDI) and High Dose Induction (HDI) on rates of participation in OUD treatment within 10 days post randomization, and opioid withdrawal symptoms, opioid craving, and use of illicit and non-prescribed drugs.

Eligible Conditions
  • Opioid Use Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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
1,051,821 Total Patients Enrolled
Alameda Health SystemOTHER
6 Previous Clinical Trials
2,966 Total Patients Enrolled
Yale UniversityLead Sponsor
1,905 Previous Clinical Trials
3,018,301 Total Patients Enrolled
~240 spots leftby Feb 2027
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