Assessing Optimal XR-Buprenorphine Initiation Points in Jail

Opioid Use Disorder Clinical Trial

Official title:

Assessing Optimal XR-Buprenorphine Initiation Points in Jail

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05481112
• Other study ID #: 22-00326
• Status: Withdrawn
• Phase: Phase 4
• Start date: November 1, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Drug:
• Extended-Release Buprenorphine Injection
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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

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	Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release	Data derived from clinic records.	Up to Month 6
Secondary	Proportion of Participants who Initiate Medication for Opioid Use Disorder (MOUD) during Incarceration Period	Includes initiation of MOUD other than XR-B.	Up to Month 6
Secondary	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.	1 Month Post-Release (Up to Month 7)
Secondary	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.	3 Months Post-Release (Up to Month 10)
Secondary	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.	Up to Month 6
Secondary	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.	Up to Month 6
Secondary	Proportion of Participants who Receive a Dose of XR-B Within 28 Days after Jail Release	Data derived from clinic records.	1 Month Post-Release (Up to Month 7)