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Compares treatment options for Opioid Use Disorder
Official title Standard Versus High Dose ED-Initiated Buprenorphine Induction
ClinicalTrials.gov ID: NCT06494904
What this study is testing
What is Buprenorphine?
Buprenorphine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for opioid use disorder.
Also referred to as Zubsolv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- All patients enrolled into the study must:
- Be 18-65 years of age.
- Be treated in the ED during study screening hours.
- Meet DSM-5 diagnostic criteria for moderate to severe OUD.
- Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment).
You likely can't join if
- All patients enrolled into the study must not:
- Have a medical or psychiatric condition that requires hospitalization at the time of index ED visit.
- Have a known hypersensitivity reaction to buprenorphine/naloxone
- Be actively suicidal or severely cognitively impaired precluding informed consent.
- Require ongoing prescription for opioid analgesics.
- Have a physical exam or reported history consistent with severe liver failure
See the full eligibility criteria
- All patients enrolled into the study must:
- Be 18-65 years of age.
- Be treated in the ED during study screening hours.
- Meet DSM-5 diagnostic criteria for moderate to severe OUD.
- Have a Clinical Opiate Withdrawal Scale (COWS) score of ≥8 at enrollment (including 2 objective signs of withdrawal at enrollment).
- Have a urine toxicology test that is positive for opioids.
- Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study.
- All patients enrolled into the study must not:
- Have a medical or psychiatric condition that requires hospitalization at the time of index ED visit.
- Have a known hypersensitivity reaction to buprenorphine/naloxone
- Be actively suicidal or severely cognitively impaired precluding informed consent.
- Require ongoing prescription for opioid analgesics.
- Have a physical exam or reported history consistent with severe liver failure
- Have a positive urine test for methadone and reported use in the past 72 hours
- Be a prisoner or in police custody at the time of index ED visit.
- Be unwilling to follow study procedures (e.g., unwilling to provide permission to contact referral provider/program or unavailable for the follow-up assessments)
- Have prior enrollment in the current study.
- Receiving MOUD treatment within the past 7 days.
- Be pregnant as determined by human gonadotropin (hCG) testing at the index ED visit
- Have a respiratory rate \<8 or oxygen saturation \<93%
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Oakland, California, United States
- San Leandro, California, United States
- Portland, Maine, United States
- Camden, New Jersey, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oakland, California, United States; San Leandro, California, United States; Portland, Maine, United States; Camden, New Jersey, United States; Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.