Clinical trial NCT06316830: Identifying Optimal Buprenorphine Dosing for Opioid Use Disorder Treatment and Prevention of Overdose
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Opioid Use Disorder
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2024-03-18
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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by the treating clinician \*Participants that become incarcerated/or in police custody during the study will be withdrawn.

Primary outcomes:
measure: Treatment Engagement
timeFrame: six months post-randomization
Secondary outcomes:
measure: Control of Opioid Cravings
timeFrame: six months post-randomization
measure: Treatment response based on use of non-prescribed opioids
timeFrame: six months post-randomization
Other outcomes:
measure: Rate of Non-fatal or Fatal Opioid Overdose
timeFrame: twelve months post-randomization
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
References:
citation: Chambers LC, Hallowell BD, Zullo AR, Paiva TJ, Berk J, Gaither R, Hampson AJ, Beaudoin FL, Wightman RS. Buprenorphine Dose and Time to Discontinuation Among Patients With Opioid Use Disorder in the Era of Fentanyl. JAMA Netw Open. 2023 Sep 5;6(9):e2334540. doi: 10.1001/jamanetworkopen.2023.34540.