search
Back to results

Assessing Optimal XR-Buprenorphine Initiation Points in Jail

Primary Purpose

Opioid Use Disorder

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Extended-Release Buprenorphine Injection
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid Use Disorder focused on measuring XR-Buprenorphine, Sublocade, Medication for Opioid Use Disorder (MOUD)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

XR-B Induction at Admission

XR-B Induction at Pre-Release

Arm Description

Participants will initiate extended-release buprenorphine (XR-B) treatment at the time of admission. XR-B will be continued monthly from the time of induction to the day of release (up to 6 months), and up to 3 monthly injections will be offered in the community following release. Dosing: XR-B is available in two doses, 300mg and 100mg. Study clinicians will generally adhere to FDA-labeling on XR-B dosing, which recommends two months of 300-mg doses followed by maintenance doses of 100-mg monthly.

Participants will initiate extended-release buprenorphine (XR-B) treatment within 30 days of release. Participants will receive at least one XR-B monthly injection prior to release, and XR-B will be continued monthly from the time of induction to the day of release. Up to 3 monthly injections will be offered in the community following release. Dosing: XR-B is available in two doses, 300mg and 100mg. Study clinicians will generally adhere to FDA-labeling on XR-B dosing, which recommends two months of 300-mg doses followed by maintenance doses of 100-mg monthly.

Outcomes

Primary Outcome Measures

Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release
Data derived from clinic records.

Secondary Outcome Measures

Proportion of Participants who Initiate Medication for Opioid Use Disorder (MOUD) during Incarceration Period
Includes initiation of MOUD other than XR-B.
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.
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.
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.
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.
Proportion of Participants who Receive a Dose of XR-B Within 28 Days after Jail Release
Data derived from clinic records.

Full Information

First Posted
July 28, 2022
Last Updated
July 18, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05481112
Brief Title
Assessing Optimal XR-Buprenorphine Initiation Points in Jail
Official Title
Assessing Optimal XR-Buprenorphine Initiation Points in Jail
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
XR-Buprenorphine, Sublocade, Medication for Opioid Use Disorder (MOUD)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XR-B Induction at Admission
Arm Type
Experimental
Arm Description
Participants will initiate extended-release buprenorphine (XR-B) treatment at the time of admission. XR-B will be continued monthly from the time of induction to the day of release (up to 6 months), and up to 3 monthly injections will be offered in the community following release. Dosing: XR-B is available in two doses, 300mg and 100mg. Study clinicians will generally adhere to FDA-labeling on XR-B dosing, which recommends two months of 300-mg doses followed by maintenance doses of 100-mg monthly.
Arm Title
XR-B Induction at Pre-Release
Arm Type
Experimental
Arm Description
Participants will initiate extended-release buprenorphine (XR-B) treatment within 30 days of release. Participants will receive at least one XR-B monthly injection prior to release, and XR-B will be continued monthly from the time of induction to the day of release. Up to 3 monthly injections will be offered in the community following release. Dosing: XR-B is available in two doses, 300mg and 100mg. Study clinicians will generally adhere to FDA-labeling on XR-B dosing, which recommends two months of 300-mg doses followed by maintenance doses of 100-mg monthly.
Intervention Type
Drug
Intervention Name(s)
Extended-Release Buprenorphine Injection
Other Intervention Name(s)
Sublocade
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release
Description
Data derived from clinic records.
Time Frame
Up to Month 6
Secondary Outcome Measure Information:
Title
Proportion of Participants who Initiate Medication for Opioid Use Disorder (MOUD) during Incarceration Period
Description
Includes initiation of MOUD other than XR-B.
Time Frame
Up to Month 6
Title
Number of Days of Opioid Use at 1 Month Post-Release
Description
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)
Title
Number of Days of Opioid Use at 3 Months Post-Release
Description
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)
Title
Mean Opioid Craving Visual Analogue Scale (OC-VAS) Score during Incarceration Period
Description
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
Title
Mean K-6 Distress Scale Score during Incarceration Period
Description
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.
Time Frame
Up to Month 6
Title
Proportion of Participants who Receive a Dose of XR-B Within 28 Days after Jail Release
Description
Data derived from clinic records.
Time Frame
1 Month Post-Release (Up to Month 7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Incarcerated adults able to provide written informed consent in English. Currently sentenced with pending release date between 3-7 months. Current moderate-to-severe opioid use disorder (DSM-5) 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) Willing to accept being randomized to initiating XR-B treatment at the time of jail admission or near the time of release. Exclusion Criteria: 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 Pregnancy, planning conception, or breast-feeding Allergy, hypersensitivity or medical contraindication to either medication Chronic pain requiring opioid pain management On methadone or buprenorphine (SL-B) maintenance prior to incarceration AND intending to remain on methadone or buprenorphine maintenance upon return to the community.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Farabee, PhD
Phone
310-963-0009
Email
David.Farabee@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Farabee, PhD
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Farabee, PhD
Phone
310-963-0009
Email
David.Farabee@nyulangone.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David Farabee; david.farabee@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will have access to data upon reasonable request. Requests should be directed to david.farabee@nyulangone.org. To gain access, data requestors will need to sign a data access agreement

Learn more about this trial

Assessing Optimal XR-Buprenorphine Initiation Points in Jail

We'll reach out to this number within 24 hrs