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 study involves two cohorts, (1) a 12mg cohort (standard) to determine baseline data and (2) a 32 mg (high dose) cohort. If the 32mg is intolerable, a 24 mg dose may be evaluated. Trial 2 is a small pilot multicenter randomized, double blinded, clinical trial in 80 participants (randomized 1:1) that will provide preliminary information on efficacy with the primary outcome being engagement in comprehensive addiction treatment 7-days post BUP induction. In collaboration with National Institute on Drug Abuse (NIDA), the research team have determined that there must be a minimum increase in engagement in comprehensive addiction treatment of 15% at 7-days in the high dose induction group to justify a larger future clinical trial.
Eligibility criteria
Qualifiers
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 Withdrawal Score (COWS) score ≥ 8
Disqualifiers
UDS positive for methadone.
Be pregnant determined by urine human chorionic gonadotropin (uHCG) testing
Have an unstable medical or psychiatric condition including suicidality requiring hospitalization
Require ongoing opioids for pain management
Trial design
Treatments tested in this trial
- High Dose Buprenorphine
- Standard Buprenorphine Dose
Treatment groups
Sponsors and collaborators
Rutgers, The State University of New Jersey
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator