A Bundled Intervention
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Alabama at Birmingham
About this trial
Opioid overdose deaths have reached historically high records in the United States and are particularly concentrated among patients after emergency department (ED) discharge. Evidence-based treatment modules to reduce repeat opioid overdose and mortality are lacking in this patient population. A bundled intervention is proposed, including telehealth, peer support specialist, buprenorphine, and linkage for definitive care, that is designed to increase treatment uptake in this patient population post-ED discharge, reduce repeat opioid overdoses, and end overdose deaths.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
discharged from the ED and inpatient settings at the UAB hospital
19 years or older (the age of majority in Alabama);
diagnosis of OUD and experiencing opioid overdose in the last 12 months;
prescribed buprenorphine in the ED and willing to continue buprenorphine post-ED discharge;
Disqualifiers
living in a restricted environment (e.g., prison or jail facility, etc.);
currently enrolled in other clinical studies;
anticipated to take other prescribed opioids except buprenorphine for a medical condition longer than three months;
known allergic reaction to buprenorphine;
Trial design
Design model
Parallel
Treatments tested in this trial
a bundled intervention
Other interventiona bundled intervention, including peer support, buprenorphine (ranging from 4mg-24mg, oral, daily), telehealth, and community-based addiction programs.
control group
Other interventionparticipants will not be intervened with this bundled treatment, but continue the usual care that has been established at UAB ED.
Treatment groups
190 Participants
are divided into 3 treatment groupsGroup A: phase 1Experimental treatment 1 intervention
Group B: phase 2- experimentalExperimental treatment 1 intervention
Group C: phase 2- controlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
participant retention rate
measure the total number of participants who complete 1- month and 3-month treatment in the study
Time frame
1 month and 3 months post ED discharge2
buprenorphine adherent rate
checking prescription rate and patients' report of their taking medication rate
Time frame
1 month and 3 months post ED discharge3
linkage rate to addiction treatment programs
patients' self report and reports from addiction treatment programs
Time frame
1 month and 3 months post ED dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov