Assessing Optimal XRB Initiation Points in Jail

PHASE4RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

June 2, 2025

Primary Completion Date

December 1, 2026

Study Completion Date

March 1, 2027

Conditions
Opioid Use Disorder
Interventions
DRUG

Extended-Release Buprenorphine (XRB)

XRB (Sublocade) will be delivered as a pre-filled 2cc subcutaneous monthly injection, using a 300mg starting dose in most cases (100mg starting doses are available per the study team's clinical judgement). XRB consists of a depot injectable formulation in polymeric solution to the abdomen and releases buprenorphine over 28-days (4-weeks) by diffusion as the polymer biodegrades. Prior to an initial injection, the participant must be stable for several days or longer on sublingual buprenorphine (SLB) at doses of 8mg/day or higher. Participants will receive at least one XRB monthly injection prior to release, which investigators anticipate to usually be the 300mg dose. Some participants will be recruited earlier during the incarceration (or experience delayed release dates and then longer than anticipated incarcerations); XRB will be continued monthly from the time of induction to the day of release.

DRUG

Sublingual Buprenorphine (SLB)

Maintenance of existing SLB prescription (treatment as usual).

Trial Locations (4)

10016

RECRUITING

NYU Langone Health - 180 Madison Ave, New York

02111

RECRUITING

Tufts University Health Sciences, Boston

01199

RECRUITING

Baystate Health, Springfield

08902

RECRUITING

Middlesex County House of Corrections, New Brunswick

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

NYU Langone Health

OTHER