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Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose (Optimal Bup)

Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose (Optimal Bup)

Recruiting
18 years and older
All
Phase N/A

Overview

The investigators aim to test the effectiveness of a high maintenance daily dose of buprenorphine (24 mg) for improving outcomes among patients who used fentanyl compared to the standard daily dose (16 mg).
The main question it aims to answer is: will patients who are randomly assigned to the high 24 mg maintenance dose, as compared to patients randomly assigned to the standard 16 mg maintenance dose, have improved retention in buprenorphine treatment (primary outcome), decreased use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (secondary outcome).

Description


Eligibility

Inclusion Criteria:
  • English-speaking
  • Age 18 years-old or older
  • Identified by the treating physician as having moderate to severe opioid use disorder (OUD)
  • Initiating or continuing buprenorphine for treatment of opioid use disorder
  • History of fentanyl use (confirmed by fentanyl positive urine drug screen (UDS) at intake OR if on buprenorphine maintenance treatment fentanyl plus a positive UDS within the last month OR self- reported ongoing fentanyl use during treatment)
Exclusion Criteria:
  • Previous enrollment in the trial
  • Incarcerated or in police custody
  • Pregnant
  • Live outside of Rhode Island (RI)
  • Unable to provide informed consent
  • Allergy to Buprenorphine

Study details
    Opioid Use Disorder

NCT06316830

22 April 2024

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