Buprenorphine for Opioid Use Disorder Treatment
Standard Versus High Dose ED-Initiated Buprenorphine Induction
Recruiting
Phase 3
Interventional Study
Opioid Use Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 360 (estimated)
- Sponsor
- Yale University · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 65 who are struggling with opioid use disorder and need treatment. Participants will receive either a standard or high dose of buprenorphine and will be monitored for their participation in treatment and symptoms related to opioid withdrawal.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 18 and 65 years old.
- I have been diagnosed with moderate to severe opioid use disorder.
- I have a current Clinical Opiate Withdrawal Scale score of 8 or higher.
- I tested positive for opioids in my urine test.
- I can speak and understand English well enough to participate.
- I am being treated in the emergency department.
- I have at least 2 signs of withdrawal.
- I can provide written consent to participate.
You may not be able to join if
- I require hospitalization for a medical or psychiatric condition.
- I am allergic to buprenorphine or naloxone.
- I am actively suicidal or severely cognitive impaired.
- I need ongoing prescription opioids for pain.
- I have severe liver failure.
- I have used methadone or tested positive for it in the past 3 days.
- I am a prisoner or in police custody.
- I am pregnant as per testing done at the emergency department.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
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 dru…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
All patients enrolled into the study must:
1. Be 18-65 years of age.
2. Be treated in the ED during study screening hours.
3. Meet DSM-5 diagnostic criteria for moderate to severe OUD.
4. Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 obje…
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