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Buprenorphine Dosing for Opioid Use Disorder

This study is looking at whether a higher daily dose of buprenorphine (24 mg) is more effective than the standard dose (16 mg) for people with opioid use disorder (OUD) who have used fentanyl. Buprenorphine is a highly effective treatment for OUD. The study wants to see if the higher dose helps people stay in treatment longer, reduces their use of non-prescribed opioids, decreases cravings, and lowers the risk of overdose. You may be able to join if you are 18 or older, speak English, have moderate to severe OUD, are starting or continuing buprenorphine, and have a history of fentanyl use. The study aims to enroll 250 participants, but its current recruitment status is unclear.

Study design
This is an interventional study comparing two different doses of buprenorphine. Participants will be randomly assigned to receive either a 16 mg or 24 mg daily dose.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Treatment engagement will be measured at six months post-randomization.

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NCT06316830

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Rhode Island Hospital
~250 participants
Updated 2025-10-23 on ClinicalTrials.gov
What's tested:Buprenorphine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment Engagement
Measured over six months post-randomization

Conditions

Opioid Use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

1 sites across 1 states
Rhode Island1

Who to contact

Jackie Goldman
[email protected]
401-808-6950
Email the study team

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Eligibility criteria

Inclusion

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

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
Concomitant medication use deemed to present potential for serious medication interaction by the treating clinician \*Participants that become incarcerated/or in police custody during the study will be withdrawn.

What this trial measures

  • Treatment Engagementsix months post-randomization

    The primary outcome is the percentage of participants retained in buprenorphine treatment. Participants will be classified as retained in buprenorphine treatment at six months post- randomization if (1) the study site data indicate that they remained engaged in treatment or (2) the PDMP suggest that they continued treatment elsewhere and have not had a gap of more than 27 days in medication on-hand based on fill dates and days' supply.