High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)
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 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 140 (estimated)
- Sponsor
- Rutgers, The State University of New Jersey · Other
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About This Trial
This project, involving two distinct clinical trials, tests whether induction to a higher than currently recommended buprenorphine (BUP) induction dose is safe and can improve the proportion of patients who engage in comprehensive addiction services within 7-day of induction.
Trial 1 is a head-to-head comparison of the safety, tolerability and feasibility of high dose BUP induction (32 mg). The s…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
* Treated in the ED during screening hours
* Meet DSM-5 diagnostic criteria for moderate to severe OUD
* Clinical Opioid …
Contacts