Assessing Optimal XRB Initiation Points in Jail

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
NYU Langone Health
Study ID
NCT06051890
Phase
PHASE4
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Sublingual Buprenorphine (SLB) — DRUG
    Maintenance of existing SLB prescription (treatment as usual).

Study Details

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.

Key Dates

Start date
Jun 2, 2025
Status verified
Sep 2025
Primary completion
Dec 1, 2026
Completion
Mar 1, 2027

Study Design

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

Arms

  • Experimental: Transition to Extended-Release Buprenorphine (XRB)
    Participants randomized to transition to treatment with XRB.
  • Active Comparator: Sublingual Buprenorphine (SLB) Maintenance
    Participants randomized to remain on-treatment with SLB.

Primary Outcome Measure

Percentage of participants released from jail with at least 7 days of buprenorphine in their system [ Time Frame: Up to Month 6 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Tufts University Health SciencesBostonMassachusetts02111
Thomas Stopka, Ph.D. (PRINCIPAL_INVESTIGATOR)
Baystate HealthSpringfieldMassachusetts01199
Peter Friedmann, MD (PRINCIPAL_INVESTIGATOR)
Middlesex County House of CorrectionsNew BrunswickNew Jersey08902
732-297-3636
Kashif Siddiqi (PRINCIPAL_INVESTIGATOR)
NYU Langone Health - 180 Madison AveNew YorkNew York10016-

Find similar trials in Boston, MA

By research site
Tufts University Health Sciences· Boston, MABaystate Health· Springfield, MAMiddlesex County House of Corrections· New Brunswick, NJNYU Langone Health - 180 Madison Ave· New York, NY

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