Buprenorphine for Individuals in Jail

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Friends Research Institute, Inc.
Study ID
NCT06306443
Phase
PHASE3
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • extended-release buprenorphine (XR-B) — DRUG
    buprenorphine

Study Details

This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months.

Key Dates

Start date
Jun 20, 2025
Status verified
May 2026
Primary completion
Jan 1, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: extended-release buprenorphine (XR-B)
    Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone. If they tolerate sl buprenorphine, on day 4 they will be administered an 8 mg dose of BRIXADI on day 5 (if they do not tolerate sl buprenorphine/naloxone we will extend sl dosing). During week two of dosing, they will receive 16 mg dose of BRIXADI will be given, based on the participant's response to the previous dose. During week three of dosing, they will receive a 24 mg dose of BRIXADI. During week four they will be administered a monthly dose of 64mg, 96mg, or 128mg. In all cases, the dose selected will be based on their response to the previous weeks' dose. We will endeavor to get you on the 96 mg or 128 mg monthly dose as there is a lack of opioid blockade data for the 64 mg monthly dose.
  • Active Comparator: sublingual buprenorphine (SL-B)
    Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone.

Primary Outcome Measure

urine toxicology [ Time Frame: 12-months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Baltimore Central Booking & Intake CenterBaltimoreMaryland21202
Michael Gordon, DPA
[email protected]
4108373977
Thomas R Blue, PhD
[email protected]
4108373977
Friends Research InstituteBaltimoreMaryland21201
Michael Gordon
[email protected]
4108373977

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Baltimore Central Booking & Intake Center· Baltimore, MDFriends Research Institute· Baltimore, MD

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