Assessing Optimal XRB Initiation Points in Jail

Assessing Optimal Extended-Release Buprenorphine (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.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Drug: Extended-Release Buprenorphine (XRB); Drug: Sublingual Buprenorphine (SLB)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: David Farabee; Phone Number: 310-963-0009; Email: David.farabee@nyulagone.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University Health Sciences
    • Springfield, Massachusetts, United States, 01199
      • Baystate Health
  • New Jersey
    • New Brunswick, New Jersey, United States, 08902
      • Middlesex County House of Corrections
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health - 180 Madison Ave

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transition to Extended-Release Buprenorphine (XRB); Participants randomized to transition to treatment with XRB.	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 (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
Active Comparator: Sublingual Buprenorphine (SLB) Maintenance; Participants randomized to remain on-treatment with SLB.	Drug: Sublingual Buprenorphine (SLB); Maintenance of existing SLB prescription (treatment as usual).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants released from jail with at least 7 days of buprenorphine in their system	The percentage of participants leaving jail with at least 7 days of buprenorphine protection in their system. Measured using clinical and jail records.	Up to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants continuing MOUD treatment in the community	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.	Up to Month 9

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: David Farabee, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): July 29, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: September 18, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: 23-00926

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the de-identified individual participant data collected during the trial will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: david.farabee@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to david.farabee@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes