High Dose Buprenorphine (BUP) Induction in the Emergency Department (ED)
ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRutgers, The State University of New Jersey
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
High Dose Buprenorphine
Drug32mg of BUP split as 16mg at 0 minutes and 16mg at 30-60 min as an induction dose
Standard Buprenorphine Dose
Drug12mg of buprenorphine (BUP) split as 8mg at 0 minutes and 4mg at time 30-60 min as an induction dose
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Buprenorphine Standard DoseActive comparator 1 intervention
Group B: Buprenorphine High DoseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of participants engaged in comprehensive addiction treatment at 7-days post-ED induction
The proportion of participants engaged in comprehensive addiction treatment at 7 days post-ED induction as verified by participant and the addiction treatment program.
Time frame
7 days post-ED visitSecondary outcomes
1
Percentage of days with opioid abstinence (Trial 1)
Participants' percentage of days with opioid abstinence (defined as negative urine drug screen (UDS)) at day 7 (Trial 1)
Time frame
at day 72
Percentage of days with opioid use (Trial 1)
Participants' percentage of days with opioid use at Time-Line Follow Back (TLFB) over 7 days post induction (inclusive) (Trial 1)
Time frame
7 days post-ED3
Percentage of days with opioid use (Trial 2)
Participants' percentage of days with opioid use at Time-Line Follow Back (TLFB) over 30 days post induction (inclusive) (Trial 2)
Time frame
30 days post-ED4
Daily assessment of opioid use (Trial 1)
Participants' daily assessment of opioid use out of days over a 7-day period (Trial 1)
Time frame
Days 1-7 after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rutgers, The State University of New Jersey
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov