Opioid Use DisorderPhase 4NCT05481112

Assessing Optimal XR-Buprenorphine Initiation Points in Jail

A Phase 4 study testing Extended-Release Buprenorphine Injection in people with Opioid Use Disorder, run by NYU Langone Health at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Opioid Use Disorder
What is being tested?: Extended-Release Buprenorphine Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2023to 1 Feb 2026
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

NYU Langone Health
New York, New York, 10016

Other trials in United States

About this study

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).

Conditions: Opioid Use Disorder
Being tested: Extended-Release Buprenorphine Injection
Keywords: XR-Buprenorphine, Sublocade, Medication for Opioid Use Disorder (MOUD)
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Extended-Release Buprenorphine InjectionDrug
Also called Sublocade
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.

Study groups in NCT05481112
Study group	Role	What they receive
XR-B Induction at Admission	Experimental	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. Receives: Drug: Extended-Release Buprenorphine Injection
XR-B Induction at Pre-Release	Experimental	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. Receives: Drug: Extended-Release Buprenorphine Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release
Data derived from clinic records.
Measured: Up to Month 6

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20231 Feb 2026

First posted1 Aug 2022
Study start1 Nov 2023 (estimated)
Primary completion1 Nov 2025 (estimated)
Study completion1 Feb 2026 (estimated)

Why it stopped: This study was not initiated due to policy changes in Massachusetts (the proposed study sites).

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05481112
Sponsor's protocol ID: 22-00326
Status last verified: Feb 2024
First submitted: 28 Jul 2022
Last updated: 29 Feb 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder

All Opioid Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing Optimal XR-Buprenorphine Initiation Points in Jail
ClinicalTrials.gov ID: NCT05481112
Acronym / sponsor ID: 22-00326
Conditions: Opioid Use Disorder
Keywords: XR-Buprenorphine, Sublocade, Medication for Opioid Use Disorder (MOUD)
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: This study was not initiated due to policy changes in Massachusetts (the proposed study sites).
Enrolment: 0 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 1 Nov 2023 (estimated)
Primary completion: 1 Nov 2025 (estimated)
Study completion: 1 Feb 2026 (estimated)
First posted: 1 Aug 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
XR-B Induction at Admission	Experimental	Drug: Extended-Release Buprenorphine InjectionParticipants 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.
XR-B Induction at Pre-Release	Experimental	Drug: Extended-Release Buprenorphine InjectionParticipants 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Extended-Release Buprenorphine InjectionAlso: SublocadeExtended-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.	Drug	XR-B Induction at Admission, XR-B Induction at Pre-Release

Primary outcome

Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release
Time frame: Up to Month 6
Data derived from clinic records.

6 secondary outcomes

Proportion of Participants who Initiate Medication for Opioid Use Disorder (MOUD) during Incarceration Period
Time frame: Up to Month 6
Number of Days of Opioid Use at 1 Month Post-Release
Time frame: 1 Month Post-Release (Up to Month 7)
Number of Days of Opioid Use at 3 Months Post-Release
Time frame: 3 Months Post-Release (Up to Month 10)
Mean Opioid Craving Visual Analogue Scale (OC-VAS) Score during Incarceration Period
Time frame: Up to Month 6
Mean K-6 Distress Scale Score during Incarceration Period
Time frame: Up to Month 6
Proportion of Participants who Receive a Dose of XR-B Within 28 Days after Jail Release
Time frame: 1 Month Post-Release (Up to Month 7)

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
Individual participant dataSharing planned: Yes. 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.

Related trials for Opioid Use Disorder

Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Farabee, PhD principal investigator

NYU Langone Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Extended-Release Buprenorphine Injection in people with Opioid Use Disorder, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release (time frame: Up to Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05481112.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.