Assessing Optimal XRB Initiation Points in Jail

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06051890
• Other study ID #: 23-00926
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 29, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: David Farabee
• Phone: 310-963-0009
• Email: David.farabee[@]nyulagone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Tufts University Health Sciences	Boston	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	Baystate Health	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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