Standard Versus High Dose ED-Initiated Buprenorphine Induction (NCT06494904) | Clinical Trial Compass
RecruitingPhase 3
Standard Versus High Dose ED-Initiated Buprenorphine Induction
United States360 participantsStarted 2024-12-06
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Engagement in Treatment (10)
Timeframe: Within 10 days after study randomization
. 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)