Assessing Optimal XRB Initiation Points in Jail
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Extended-Release Buprenorphine (XRB), Sublingual Buprenorphine (SLB).
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: No limits · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail
Overview
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.
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 (S - Drug Sublingual Buprenorphine (SLB)
Maintenance of existing SLB prescription (treatment as usual).
Primary outcome measures
- Percentage of participants released from jail with at least 7 days of buprenorphine in their system [Time frame: Up to Month 6]
Secondary outcome measures (1)
- Percentage of participants continuing MOUD treatment in the community [Time frame: Up to Month 9]
Eligibility criteria
Inclusion criteria
- Incarcerated men able to provide written informed consent in English.\*
- Unsentenced.
- Entering the facility with a prescription for SLB and receiving SLB for at least the previous 3 days.
- Minimum anticipated jail stay is 4 days.
- Willing to accept being randomized to the experimental condition (i.e., transitioning to XRB while incarcerated).
Exclusion criteria
- Sentenced.
- Allergy, hypersensitivity or medical contraindication to either medication.
- Chronic pain requiring opioid pain management or other contraindicated medications.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Tufts University Health Sciences — Boston
- Baystate Health — Springfield
- Middlesex County House of Corrections — New Brunswick
- NYU Langone Health - 180 Madison Ave — New York
Identifiers
NCT: NCT06051890 · 23-00926