Assessing Optimal XR-Buprenorphine Initiation Points in Jail

NYU Langone Health

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Conditions

Opioid Use Disorder

Interventions

Extended-Release Buprenorphine InjectionDRUG

Extended-release buprenorphine (XR-B, Sublocade) is manufactured by Indivior. XR-B 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release

Data derived from clinic records.

Time frame: Up to Month 6

Secondary Outcomes

Proportion of Participants who Initiate Medication for Opioid Use Disorder (MOUD) during Incarceration Period

Includes initiation of MOUD other than XR-B.

Time frame: Up to Month 6

Number of Days of Opioid Use at 1 Month Post-Release

Participants will self-report opioid use using the Timeline Followback (TLFB) method, which asks participants to estimate number of days of drug use over the previous month.

Time frame: 1 Month Post-Release (Up to Month 7)

Number of Days of Opioid Use at 3 Months Post-Release

Participants will self-report opioid use using the Timeline Followback (TLFB) method, which asks patients to estimate number of days of drug use over the previous month.

Time frame: 3 Months Post-Release (Up to Month 10)

Mean Opioid Craving Visual Analogue Scale (OC-VAS) Score during Incarceration Period

Participants indicate their level of craving for opioids by marking a 100mm visual analogue scale where 0 = no craving and 100 = maximal craving. The questionnaire is administered at baseline and then monthly over the incarceration phase.

Time frame: Up to Month 6

Mean K-6 Distress Scale Score during Incarceration Period

K-6 Distress Scale is a 6-item self-report measure of psychological distress. Participants rank each item on a 5-point Likert scale ranging from 0 (None of the time) to 4 (All of the time). The total score is the sum of responses and ranges from 0 to 24; higher scores indicate higher levels of psychological distress. The questionnaire is administered at baseline and then monthly over the incarceration phase.

Data from ClinicalTrials.gov

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