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

Opioid Use Disorder Clinical Trial

— Optimal Bup  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06316830
• Other study ID #: STUDY00000075
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: March 2024
• Source: Rhode Island Hospital
• Contact: Alyssa Peachey, MHA
• Phone: 401-808-6950
• Email: alyssa_peachey[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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), decreased use of non-prescribed opioids (secondary outcome), decreased opioid cravings (secondary outcome), and decreased risk of fatal and non-fatal opioid overdose (secondary outcome).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: April 30, 2027
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	Brown University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Engagement	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.	six months post-randomization
Secondary	Use of non-prescribed opioids	Non-prescribed fentanyl and other opioid use will be assessed via urine drug screens (UDS) plus fentanyl test strip assessment on a monthly basis for six months after study enrollment.	six months post-randomization
Secondary	Control of Opioid Cravings	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.	six months post-randomization
Secondary	Rate of Non-fatal or Fatal Opioid Overdose	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.	twelve months post-randomization
Secondary	Use of non-prescribed opioids	Non-prescribed fentanyl and other opioid use will self reported via a Time Line Followback (TLFB) assessing ongoing non-prescribed opioid/fentanyl use at 1, 3, and 6 months.	six months post-randomization