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NCT Number: NCT06051890

Assessing Optimal XRB Initiation Points in Jail

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Tufts University Health Sciences, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extended-Release Buprenorphine (XRB)

Drug

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.

Other names: Sublocade

Sublingual Buprenorphine (SLB)

Drug

Maintenance of existing SLB prescription (treatment as usual).

Primary outcomes

  1. Percentage of participants released from jail with at least 7 days of buprenorphine in their system

    Time frame: Up to Month 6

    The percentage of participants leaving jail with at least 7 days of buprenorphine protection in their system. Measured using clinical and jail records.

Secondary outcomes

  1. Percentage of participants continuing MOUD treatment in the community

    Time frame: Up to Month 9

    Percentage of participants who continue to access medication for opioid use disorder (MOUD) once released from jail. This will be based on community clinic records indicating admission and retention.

Study contacts

Contact information is provided by the study sponsor or research team.

David Farabee

CONTACT

[email protected]

310-963-0009

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 25, 2023
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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