Injectable Buprenorphine in Prison: a Preference Trial

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2027

Conditions
Opioid Use DisorderIncarcerationMedications for Opioid Use DisorderBuprenorphine
Interventions
DRUG

Brixadi (Injectable Buprenorphine)

Brixadi comes in several doses and can be administered on a weekly or monthly basis. For clinical reasons (i.e., each patient will already be on a stable dose of MOUD in a setting without significant illicit opioid use), the monthly injection will be used. The approximately equivalent to the 300mg Sublocade dose is 96mg of Brixadi. The maximum dose is 128mg. Brixadi can be administered in the abdomen, buttocks, or triceps. Participants in the Brixadi treatment arm will be given one or more Brixadi injections each month prior to release from prison and each month after release. They can continue to receive the medication after the conclusion of the trial. Brixadi is covered by most Medicaid health insurances in the state of Rhode Island.

DRUG

Sublocade

Sublocade is a 100mg or 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. Participants in the Sublocade treatment arm will be given monthly Sublocade injections, as clinically indicated, each month prior to release from prison and each month after release. They can continue to receive the medication after the conclusion of the trial. Sublocade is covered by most Medicaid health insurances in the state of Rhode Island. The standard dosing schedule is two months of 300mg followed by monthly 100mg injections. To maximize real-world generalizability, the medication dosing will be determined by clinical indication of the provider who will have the flexibility to provide medication dosing based on their clinical acumen and/or shared decision-making.

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Lifespan

OTHER