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NCT Number: NCT06316830

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Brown University

Providence, Rhode Island, 02912, United States

Location status: Recruiting

Location contact

Francesca Beaudoin

PRINCIPAL_INVESTIGATOR

Jackie Goldman

CONTACT

[email protected]

401-808-6950

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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by the treating clinician *Participants that become incarcerated/or in police custody during the study will be withdrawn.

Treatment and study plan

buprenorphine

Drug

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 outcomes

  1. Treatment Engagement

    Time frame: six 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.

Secondary outcomes

  1. Control of Opioid Cravings

    Time frame: six months post-randomization

    Measured using patient reported outcomes via the Opioid Craving Scale, a reliable, validated scale for people with opioid use disorder. The scale consists of three questions related to opioid cravings rated on a scale of 1-10 with 1 being not at all and 10 being extremely. A higher score denotes increased opioid cravings.

  2. Treatment response based on use of non-prescribed opioids

    Time frame: six months post-randomization

    Non-prescribed fentanyl and other opioid use will be assessed via urine drug screens including fentanyl (UDS) and self-report. UDS will be assessed monthly for six months after study enrollment. Self-reported will be assessed at 1, 3, and 6 months via a Time Line Followback (TLFB) assessing ongoing non-prescribed opioid/fentanyl over the preceding two weeks. Based on UDS and self-reported data, participants will be classified as treatment responders if they have (1) no evidence (negative UDS and negative self-report) of non-prescribed opioid use at ≥1 assessment in months 1 to 3 AND (2) no evidence of non-prescribed opioid use at ≥2 assessments in months 4 to 6.

Other outcomes

  1. Rate of Non-fatal or Fatal Opioid Overdose

    Time frame: twelve months post-randomization

    Non-fatal and fatal opioid overdoses will be assessed using statewide data from the Rhode Island Department of Health, including the Emergency Medical Services (EMS) Information System, Opioid Overdose Reporting System (OORS), and Office of the State Medical Examiners (OSME). All of these systems report non-fatal or fatal opioid overdoses which investigators will aggregate to arrive at the rate of non-fatal or fatal opioid overdoses.

Study contacts

Contact information is provided by the study sponsor or research team.

Jackie Goldman

CONTACT

[email protected]

401-808-6950

Rachel Wightman, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • Brown University

Registry information

Official study title

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

Acronym: Optimal Bup

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2024
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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