Opioid Use DisorderPhase 4NCT06051890
Assessing Optimal XRB Initiation Points in Jail
A Phase 4 study testing Extended-Release Buprenorphine (XRB) and Sublingual Buprenorphine (SLB) in people with Opioid Use Disorder, run by NYU Langone Health at 4 sites in United States.
Trial summary
This application describes a 3-year, randomized controlled trial. Eligible, consenting adults (N=200) with existing sublingual buprenorphine (SLB) prescriptions who enter Middlesex County House of Corrections (MCHOC) as pre-trial detainees will be randomized at admission on a 1:1 basis to be inducted onto… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Extended-Release Buprenorphine (XRB) and Sublingual Buprenorphine (SLB)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Jun 2025to 1 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Incarcerated men able to provide written informed consent in English.*
- Unsentenced.
- Entering the facility with a prescription for SLB and receiving SLB for at least the previous 3 days.
- Minimum anticipated jail stay is 4 days.
- Willing to accept being randomized to the experimental condition (i.e., transitioning to XRB while incarcerated).
Who cannot join
- Sentenced.
- Allergy, hypersensitivity or medical contraindication to either medication.
- Chronic pain requiring opioid pain management or other contraindicated medications.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Tufts University Health Sciences
Boston, Massachusetts, 02111
Thomas Stopka, Ph.D.
- Recruiting
Middlesex County House of Corrections
New Brunswick, New Jersey, 08902
732-297-3636
Kashif Siddiqi
- Recruiting
NYU Langone Health - 180 Madison Ave
New York, New York, 10016
- Recruiting
Baystate Health
Springfield, Massachusetts, 01199
Peter Friedmann, MD
About this study
Official title: Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail
This application describes a 3-year, randomized controlled trial. Eligible, consenting adults (N=200) with existing sublingual buprenorphine (SLB) prescriptions who enter Middlesex County House of Corrections (MCHOC) as pre-trial detainees will be randomized at admission on a 1:1 basis to be inducted onto extended-release buprenorphine (XRB) at the time of admission (experimental condition) or remain in SLB (E-TAU; all participants will also receive naloxone). The two approaches will be compared with regard to (1) the percentage of participants released from jail with at least 7 days of buprenorphine in their system, (2) percentage of participants continuing MOUD treatment in the community, and (3) infractions related to buprenorphine diversion.
- Conditions
- Opioid Use Disorder
- Being tested
- Extended-Release Buprenorphine (XRB), Sublingual Buprenorphine (SLB)
- 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 (XRB)Drug
Also called Sublocade
XRB (Sublocade) will be delivered as a pre-filled 2cc subcutaneous monthly injection, using a 300mg starting dose in most cases (100mg starting doses are available per the study team's clinical judgement). XRB 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. Prior to an initial injection, the participant must be stable for several days or longer on sublingual buprenorphine (SLB) at doses of 8mg/day or higher. Participants will receive at least one XRB monthly injection prior to release, which investigators anticipate to usually be the 300mg dose. Some participants will be recruited earlier during the incarceration (or experience delayed release dates and then longer than anticipated incarcerations); XRB will be continued monthly from the time of induction to the day of release.
Sublingual Buprenorphine (SLB)Drug
Maintenance of existing SLB prescription (treatment as usual).
| Study group | Role | What they receive |
|---|---|---|
| Transition to Extended-Release Buprenorphine (XRB) | Experimental | Participants randomized to transition to treatment with XRB. Receives: Drug: Extended-Release Buprenorphine (XRB) |
| Sublingual Buprenorphine (SLB) Maintenance | Active comparator | Participants randomized to remain on-treatment with SLB. Receives: Drug: Sublingual Buprenorphine (SLB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants released from jail with at least 7 days of buprenorphine in their system
The percentage of participants leaving jail with at least 7 days of buprenorphine protection in their system. Measured using clinical and jail records.
Measured: Up to Month 6
Secondary outcomes (1)
Percentage of participants continuing MOUD treatment in the community
Percentage of participants who continue to access medication for opioid use disorder (MOUD) once released from jail. This will be based on community clinic records indicating admission and retention.
Measured: Up to Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start2 Jun 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- David Farabee, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051890
- Sponsor's protocol ID
- 23-00926
- Status last verified
- Aug 2026
- First submitted
- 18 Sep 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the de-identified individual participant data collected during the trial 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@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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Optimal Extended-Release Buprenorphine (XRB) Initiation Points in Jail
- ClinicalTrials.gov ID
- NCT06051890
- Acronym / sponsor ID
- 23-00926
- Conditions
- Opioid Use Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 25 Sep 2023 (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.
This application describes a 3-year, randomized controlled trial. Eligible, consenting adults (N=200) with existing sublingual buprenorphine (SLB) prescriptions who enter Middlesex County House of Corrections (MCHOC) as pre-trial detainees will be randomized at admission on a 1:1 basis to be inducted onto extended-release buprenorphine (XRB) at the time of admission (experimental condition) or remain in SLB (E-TAU; all participants will also receive naloxone). The two approaches will be compared with regard to (1) the percentage of participants released from jail with at least 7 days of buprenorphine in their system, (2) percentage of participants continuing MOUD treatment in the community, and (3) infractions related to buprenorphine diversion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transition to Extended-Release Buprenorphine (XRB) | Experimental | Drug: Extended-Release Buprenorphine (XRB)Participants randomized to transition to treatment with XRB. |
| Sublingual Buprenorphine (SLB) Maintenance | Active comparator | Drug: Sublingual Buprenorphine (SLB)Participants randomized to remain on-treatment with SLB. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Incarcerated men able to provide written informed consent in English.*
- Unsentenced.
- Entering the facility with a prescription for SLB and receiving SLB for at least the previous 3 days.
- Minimum anticipated jail stay is 4 days.
- Willing to accept being randomized to the experimental condition (i.e., transitioning to XRB while incarcerated).
Key exclusion criteria (3 listed)
- Sentenced.
- Allergy, hypersensitivity or medical contraindication to either medication.
- Chronic pain requiring opioid pain management or other contraindicated medications.
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 (XRB)Also: SublocadeXRB (Sublocade) will be delivered as a pre-filled 2cc subcutaneous monthly injection, using a 300mg starting dose in most cases (100mg starting doses are available per the study team's clinical judgement). XRB 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. Prior to an initial injection, the participant must be stable for several days or longer on sublingual buprenorphine (SLB) at doses of 8mg/day or higher. Participants will receive at least one XRB monthly injection prior to release, which investigators anticipate to usually be the 300mg dose. Some participants will be recruited earlier during the incarceration (or experience delayed release dates and then longer than anticipated incarcerations); XRB will be continued monthly from the time of induction to the day of release. | Drug | Transition to Extended-Release Buprenorphine (XRB) |
| Sublingual Buprenorphine (SLB)Maintenance of existing SLB prescription (treatment as usual). | Drug | Sublingual Buprenorphine (SLB) Maintenance |
Primary outcome
Percentage of participants released from jail with at least 7 days of buprenorphine in their system
Time frame: Up to Month 6
The percentage of participants leaving jail with at least 7 days of buprenorphine protection in their system. Measured using clinical and jail records.
1 secondary outcome
Percentage of participants continuing MOUD treatment in the community
Time frame: Up to Month 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. All of the de-identified individual participant data collected during the trial 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@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
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)
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Not yet recruiting
Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for OUD
Opioid Use Disorder
Not yet recruitingEarly Phase 1
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
RecruitingObservational study
Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
Opioid-Related Disorders, Drug Addiction
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.
David Farabee, PhD principal investigator
NYU Langone Health
4 sites 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 (XRB) and Sublingual Buprenorphine (SLB) in people with Opioid Use Disorder, run by NYU Langone Health at 4 sites 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 3 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: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Farabee (310-963-0009, David.farabee@nyulagone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants released from jail with at least 7 days of buprenorphine in their system (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?
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 7 Aug 2026.