Comparing standard and high doses of buprenorphine for opioid use disorder treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a multisite, double-blind, double-dummy, randomized study that aims to enroll emergency department patients with untreated moderate to severe opioid use disorder. It compares the effectiveness of standard dose induction (SDI) versus high dose induction (HDI) of buprenorphine in promoting participation in opioid use disorder treatment within 10 days post-randomization. The study will also evaluate differences in opioid withdrawal symptoms, cravings, and the use of illicit drugs. Approximately four emergency department systems across the U.S. will be involved in recruiting participants for this trial.

Why it matters

Who can join: the full rules

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 objective signs of withdrawal at enrollment).
5. Have a urine toxicology test that is positive for opioids.
6. Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

All patients enrolled into the study must not:

1. Have a medical or psychiatric condition that requires hospitalization at the time of index ED visit.
2. Have a known hypersensitivity reaction to buprenorphine/naloxone
3. Be actively suicidal or severely cognitively impaired precluding informed consent.
4. Require ongoing prescription for opioid analgesics.
5. Have a physical exam or reported history consistent with severe liver failure
6. Have a positive urine test for methadone and reported use in the past 72 hours
7. Be a prisoner or in police custody at the time of index ED visit.
8. Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments)
9. Have prior enrollment in the current study.
10. Receiving MOUD treatment within the past 7 days.
11. Be pregnant as determined by human gonadotropin (hCG) testing at the index ED visit
12. Have a respiratory rate \<8 or oxygen saturation \<93%
13. Be a participant in any other clinical trial in which medications are being delivered or the use of an investigational drug or device within the last 30 days

Where it's running

• Highland Hospital
  Oakland, California, United States Recruiting
• San Leandro Hospital
  San Leandro, California, United States Recruiting
• Maine Medical Center
  Portland, Maine, United States Recruiting
• Cooper University Hospital
  Camden, New Jersey, United States Recruiting
• University of Utah Hospital
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Principal investigator: Gail D'Onofrio, MD, MS — Yale University
• Study coordinator: Gail D'Onofrio, MD, MS
• Email: gail.donofrio@yale.edu
• Phone: 2037857059

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CBD for Opioid Dependence and Pain on Buprenorphine

  This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.

  Recruiting Early Phase 1 Yale University · West Haven, Connecticut · NCT07886606

• Cebranopadol for opioid withdrawal in adults with chronic pain

  This study tests whether cebranopadol can reduce withdrawal symptoms in adults with chronic pain who are physically dependent on prescribed opioids, compared with placebo.

  Recruiting at 2 sites Phase 2 Adneuris Therapeutics, Inc. · North Canton, Ohio and 1 other locations · NCT07874620

• emPath platform pilot to link and keep adults with opioid use disorder in care in Durham

  This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.

  Recruiting Duke University · Durham, North Carolina · NCT07810322

• CB1 Receptors in Opioid Use Disorder Measured with a PET Radioligand

  This study tests CB1 receptor availability in people with opioid use disorder starting opioid agonist therapy and compares them with healthy adults.

  Recruiting Phase 1 Yale University · New Haven, Connecticut · NCT07800520

• STORC: Training a support person plus patient navigation after birth

  We’re testing whether training a designated support person and using patient navigation after delivery helps people with opioid use disorder build recovery resources and stay in treatment.

  Recruiting Friends Research Institute, Inc. · Philadelphia, Pennsylvania · NCT07787039

• Personalized Addiction Treatment Enhancement for Opioid Use Disorder

  A digital platform run by peer recovery supporters will be tested to help adults with opioid use disorder who are on buprenorphine or methadone stay in treatment and improve outcomes.

  Recruiting Rhode Island Hospital · Providence, Rhode Island · NCT07778394

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.