Assessing Optimal XRB Initiation Points in Jail
ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
AgeNot listed
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Sentenced.
Allergy, hypersensitivity or medical contraindication to either medication.
Chronic pain requiring opioid pain management or other contraindicated medications.
Trial design
Treatments tested in this trial
- Extended-Release Buprenorphine (XRB)
- Sublingual Buprenorphine (SLB)
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
NYU Langone Health
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov