RECRUITING

Assessing Optimal XRB Initiation Points in Jail

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-02
Study Completion:2027-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06051890

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Incarcerated men able to provide written informed consent in English.\*
  2. * Unsentenced.
  3. * Entering the facility with a prescription for SLB and receiving SLB for at least the previous 3 days.
  4. * Minimum anticipated jail stay is 4 days.
  5. * Willing to accept being randomized to the experimental condition (i.e., transitioning to XRB while incarcerated).
  1. * Sentenced.
  2. * Allergy, hypersensitivity or medical contraindication to either medication.
  3. * Chronic pain requiring opioid pain management or other contraindicated medications.

Contacts and Locations

Study Contact

David Farabee
CONTACT
310-963-0009
David.farabee@nyulagone.org

Principal Investigator

David Farabee, PhD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: NYU Langone Health

  • David Farabee, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-02
Study Completion Date2027-03-01

Study Record Updates

Study Start Date2025-06-02
Study Completion Date2027-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder