Recruiting
Phase 2
Phase 3

Buprenorphine

Sponsor:

Rhode Island Hospital

Code:

NCT06316830

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Buprenorphine

Study Details

Brief 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).

Conditions

Opioid Use Disorder

Study ID

NCT06316830

Start date

Jan 6, 2025

Status verified date

Oct, 2025

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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by the treating clinician \*Participants that become incarcerated/or in police custody during the study will be withdrawn.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Buprenorphine

Buprenorphine in a highly effective treatment for opioid use disorder (OUD). Buprenorphine dose guidelines for OUD treatment were determined by clinical trials conducted in populations with a history of heroin use. However, fentanyl is changing the calculation of treatment, and optimal buprenorphine dosing for people who use fentanyl is unknown.

Primary outcome measure

  • Treatment Engagement [ Time Frame: six months post-randomization ]

Central Contacts and Locations

Central contacts

Jackie Goldman

401-808-6950jacqueline_goldman1@brown.edu

Rachel Wightman, MD

rachel_wightman@brown.edu

Locations

Brown University

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

Jackie Goldman

401-808-6950jacqueline_goldman1@brown.edu

Principal Investigator:

Francesca Beaudoin

More Information

Sponsor

Rhode Island Hospital

Last update posted

Oct 23, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2025-10-23.