Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
200 participants
INTERVENTIONAL
2025-06-02
2027-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transition to Extended-Release Buprenorphine (XRB)
Participants randomized to transition to treatment with XRB.
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
Participants randomized to remain on-treatment with SLB.
Sublingual Buprenorphine (SLB)
Maintenance of existing SLB prescription (treatment as usual).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Allergy, hypersensitivity or medical contraindication to either medication.
* Chronic pain requiring opioid pain management or other contraindicated medications.
MALE
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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David Farabee, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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23-00926
Identifier Type: -
Identifier Source: org_study_id
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