Clinical trial NCT05481112: Assessing Optimal XR-Buprenorphine Initiation Points in Jail
Official title: Assessing Optimal XR-Buprenorphine Initiation Points in Jail
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Opioid Use Disorder
Keywords: XR-Buprenorphine
Sublocade
Medication for Opioid Use Disorder (MOUD)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to compare two approaches for commencing pharmacotherapy with injectable buprenorphine for opioid use disorder (OUD) among jail inmates: (1) at the time of admission or (2) shortly before release. A sample of eligible inmates with sentences of less than 180 days will be randomly assigned to (1) initiating extended-release buprenorphine (XR-B) treatment at the time of admission (n=80), or (2) initiating XR-B treatment within 30 prior to their scheduled release date (n=80). The groups will be compared with regard to (1) how likely they were to participate in treatment, (2) levels of in-jail opioid use (via post-release interviews), (3) continuation of pharmacotherapy and other OUD treatment in the community, and (4) levels of opioid use 4 and 12 weeks following discharge (self-report and incentivized voluntary urine tests).


Eligibility criteria: Inclusion Criteria:

1. Incarcerated adults able to provide written informed consent in English.
2. Currently sentenced with pending release date between 3-7 months.
3. Current moderate-to-severe opioid use disorder (DSM-5)
4. Reasonable likelihood of completing 3-months or longer of community treatment (i.e., no plans to be transferred out of state or to another correctional facility)
5. Willing to accept being randomized to initiating XR-B treatment at the time of jail admission or near the time of release.

Exclusion Criteria:

1. Severe medical or psychiatric disability making participation unsafe or regular follow-up unlikely, including patients with pre-existing moderate to severe hepatic impairment are not eligible to participate
2. Pregnancy, planning conception, or breast-feeding
3. Allergy, hypersensitivity or medical contraindication to either medication
4. Chronic pain requiring opioid pain management
5. On methadone or buprenorphine (SL-B) maintenance prior to incarceration AND intending to remain on methadone or buprenorphine maintenance upon return to the community.

Primary outcomes:
measure: Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release
timeFrame: Up to Month 6
Secondary outcomes:
measure: Proportion of Participants who Initiate Medication for Opioid Use Disorder (MOUD) during Incarceration Period
timeFrame: Up to Month 6
measure: Number of Days of Opioid Use at 1 Month Post-Release
timeFrame: 1 Month Post-Release (Up to Month 7)
measure: Number of Days of Opioid Use at 3 Months Post-Release
timeFrame: 3 Months Post-Release (Up to Month 10)
measure: Mean Opioid Craving Visual Analogue Scale (OC-VAS) Score during Incarceration Period
timeFrame: Up to Month 6
measure: Mean K-6 Distress Scale Score during Incarceration Period
timeFrame: Up to Month 6
measure: Proportion of Participants who Receive a Dose of XR-B Within 28 Days after Jail Release
timeFrame: 1 Month Post-Release (Up to Month 7)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: David Farabee, PhD
role: PRINCIPAL_INVESTIGATOR
References: