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Assessing Optimal XRB Initiation Points in Jail
Sponsor: NYU Langone Health
Summary
This application describes a 3-year, randomized controlled trial. Eligible, consenting adults (N=200) with existing sublingual buprenorphine (SLB) prescriptions who enter Middlesex County House of Corrections (MCHOC) as pre-trial detainees will be randomized at admission on a 1:1 basis to be inducted onto extended-release buprenorphine (XRB) at the time of admission (experimental condition) or remain in SLB (E-TAU; all participants will also receive naloxone). The two approaches will be compared with regard to (1) the percentage of participants released from jail with at least 7 days of buprenorphine in their system, (2) percentage of participants continuing MOUD treatment in the community, and (3) infractions related to buprenorphine diversion.
Official title: Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail
Key Details
Gender
MALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-06-02
Completion Date
2027-03-01
Last Updated
2025-09-10
Healthy Volunteers
No
Conditions
Interventions
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.
Sublingual Buprenorphine (SLB)
Maintenance of existing SLB prescription (treatment as usual).
Locations (4)
Tufts University Health Sciences
Boston, Massachusetts, United States
Baystate Health
Springfield, Massachusetts, United States
Middlesex County House of Corrections
New Brunswick, New Jersey, United States
NYU Langone Health - 180 Madison Ave
New York, New York, United States