Randomized Clinical Trial of a 16 mg vs. 24 mg Maintenance Daily Dose of Buprenorphine to Increase Retention in Treatment Among People With Opioid Use Disorder

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Rhode Island
Brown University
RECRUITING
Providence
Contact Information
Primary
Alyssa Peachey, MHA
alyssa_peachey@brown.edu
401-808-6950
Backup
Rachel Wightman, MD
rachel_wightman@brown.edu
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 250
Treatments
Experimental: High Maintenance Daily Dose (24mg)
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.
Active_comparator: Standard Maintenance Daily Dose (16mg)
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.
Related Therapeutic Areas
Sponsors
Collaborators: Brown University
Leads: Rhode Island Hospital

This content was sourced from clinicaltrials.gov

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