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

Lifespan

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Opioid Use Disorder

Treatments: Drug: Buprenorphine

Study type: Interventional

Funder types: Other

Identifiers

NCT06316830

STUDY00000075

Details and patient eligibility

About

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), improved treatment response based on use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (exploratory outcome).

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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by the treating clinician *Participants that become incarcerated/or in police custody during the study will be withdrawn.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

High Maintenance Daily Dose (24mg)

Experimental group

Description:

The experimental intervention is a high daily maintenance dose of buprenorphine (24 mg) plus any usual clinical care the participant receives at the clinic. This high daily dose is the upper limit of the FDA-approved dose range and was selected based on preclinical studies, clinician anecdotes, case reports, and retrospective analyses suggesting improved effectiveness of higher buprenorphine doses among patients with a history of fentanyl use. Underlying pharmacodynamic principles support that the 24 mg daily dose of buprenorphine is likely to be well-tolerated, safe, and better control cravings among people with a history of fentanyl use.

Treatment:

Drug: Buprenorphine

Standard Maintenance Daily Dose (16mg)

Active Comparator group

Description:

The control intervention is the FDA-recommended target daily maintenance dose of buprenorphine (16 mg) plus any usual clinical care the participant receives at the clinic.

Treatment:

Drug: Buprenorphine