Evaluating Buprenorphine/Naloxone Microdosing vs. Standard Dosing in Emergency Departments

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of British Columbia

About this trial

This is a multi-centre, open-label RCT at four Emergency Departments (EDs) in British Columbia and Alberta. The purpose of the current study is to compare the effectiveness of buprenorphine/naloxone microdosing and standard dosing take-home induction regimens at enabling patients to successfully complete the induction regimen, and at retaining patients on opioid agonist therapy.

We will randomize our enrolled patients to receive take-home microdosing or standard dosing packages of buprenorphine/naloxone. For the microdosing arm, patients immediately start taking low doses that increase to effective levels without requiring them to go into withdrawal.

We hypothesize that ED patients provided buprenorphine/naloxone microdosing packages will be more likely to successfully complete the induction period compare to patients provided standard dosing packages. We furthermore hypothesize that those provided microdosing will be more likely to be retained in opioid agonist therapy, and will experience lower overdose, mortality, and healthcare utilization subsequent to their ED visit.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Active withdrawal at time of ED assessment (Clinical Opiate Withdrawal Score [COWS] >12)

Admitted to hospital

Severe communication barriers that inhibit patients' understanding of study procedures and interventions

Are taking opioids for cancer or palliative-care related indications

Trial design

Design model

Parallel

Treatments tested in this trial

  • Buprenorphine/naloxone

    Drug

    Buprenorphine/naloxone is a first line, evidence-based opioid agonist therapy that improves mortality for people with opioid use disorder, and that has been demonstrated to be effective at retaining people in addictions care and decreasing illicit opioid use when initiated from EDs.

Treatment groups

658 Participants
are divided into 2 treatment groups
Group A: Buprenorphine/naloxone MicrodosingActive comparator 1 intervention
Group B: Buprenorphine/naloxone Standard DosingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients who have filled a prescription for buprenorphine/naloxone within two weeks of their ED visit.

Number of patients who have filled a prescription for buprenorphine/naloxone within two weeks of their ED visit.

Time frame
14 days

Secondary outcomes

1

Number of patients retained in Opioid agonist therapy (OAT) following the ED visit

Number of patients retained in Opioid agonist therapy (OAT) following the ED visit

Time frame
30, 90, and 365 days
2

Number of fatal or non-fatal overdose events, mortality, ED visits, physician visits, admissions, and days admitted to hospital for patients following ED visit.

Number of fatal or non-fatal overdose events, mortality, ED visits, physician visits, admissions, and days admitted to hospital for patients following ED visit.

Time frame
30, 90, and 365 days.

Other outcomes

Sponsors and contacts

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