Opioid Use DisorderPhase 4NCT06880718
Injectable Buprenorphine in Prison: A Preference Trial
A Phase 4 study testing Brixadi (Injectable Buprenorphine) and Sublocade in people with Opioid Use Disorder and Incarceration, run by Lifespan at 1 site in United States.
Trial summary
The goal of this pilot trial is to compare two branded extended-release buprenorphine (XR-B) formulations (Sublocade vs. Brixadi) to explore how they improve treatment retention after release from prison among incarcerated individuals with opioid use disorder (OUD) who are transitioning back into the community. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Incarceration, Medications for Opioid Use Disorder
- What is being tested?
- Brixadi (Injectable Buprenorphine) and Sublocade
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2026to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be at least 18 years of age and incarcerated in the RIDOC facility,
- be currently diagnosed with OUD and enrolled in the RIDOC MOUD program,
- have an expected release date within 120 days of study enrollment,
- have an interest in XR-B and
- be English speaking
Who cannot join
- individuals who are pregnant or planning conception,
- diagnosed with a severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely,
- have a release date within 21 days of initiation, or
- have previously had an allergy to buprenorphine. Post-enrollment exclusion will include individuals if there is a change in release date beyond the 120 days and therefore no longer meet original inclusion criteria. These individuals would return to usual MOUD care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Department of Corrections
Cranston, Rhode Island, 02920
Jessica Miggliacio, 401-462-6721, Jessica.Migliaccio@doc.ri.gov
About this study
Official title: Injectable Buprenorphine During Transition Out of Prison: A Partially Randomized Preference Pilot Trial
The goal of this pilot trial is to compare two branded extended-release buprenorphine (XR-B) formulations (Sublocade vs. Brixadi) to explore how they improve treatment retention after release from prison among incarcerated individuals with opioid use disorder (OUD) who are transitioning back into the community.
The main question it aims to answer are:
Read more
How do Sublocade and Brixadi compare in terms of feasibility, acceptability, and effectiveness? Does giving people a choice of medication affect how well they stay in treatment?
Using a partially randomized preference trial approach, there will be a comparison between participants who choose their XR-B formulation to those who are randomly assigned to see if patient preference influences treatment outcomes. The trial is a hybrid implementation-effectiveness trial.
Participants will:
- Choose which medication they prefer or be randomly assigned if they don't have a preference.
- Receive monthly injections of either Sublocade or Brixadi before and after release from prison.
- Complete surveys and clinical assessments on treatment experience and acceptability.
- Be monitored for treatment retention, opioid use, and adverse events for six months post-release.
Researchers will compare the two treatments to see which one works better for people leaving prison and if allowing people to choose their treatment improves results.
Read the detailed description
This study is a pilot hybrid effectiveness-implementation trial using a partially randomized preference trial (PRPT) design to evaluate two formulations of extended-release buprenorphine (XR-B)-Sublocade and Brixadi-for the treatment of opioid use disorder (OUD) in individuals transitioning from prison to the community. The study is being conducted in collaboration with the Rhode Island Department of Corrections (RIDOC) to assess treatment retention, feasibility, and acceptability and other implementation outcomes in a carceral setting.
STUDY OBJECTIVES As a hybrid trial, the study will assess effectiveness and implementation outcomes. The primary objective of this study is to compare effectiveness (post-release treatment retention) among participants who receive Sublocade or Brixadi before and after release from prison. The study also aims to evaluate the impact of patient preference on treatment outcomes, including differences in retention between those who choose their treatment and those who are randomized. The study will also assess implementation outcomes including feasibility, acceptability, and fidelity.
STUDY DESIGN This is a pilot hybrid effectiveness-implementation trial that incorporates a partially randomized preference trial (PRPT) design.
Participants with a clear preference for either Sublocade or Brixadi will receive their preferred treatment. Participants with no strong preference will be randomized 1:1 using a stratified block randomization approach, stratified by gender, with blocks of four. Randomization assignments will be concealed using opaque sealed envelopes. The study is open-label, meaning both participants and study staff will be aware of treatment assignments. Given the preference-based design, blinding is not feasible.
STUDY SETTING The study will recruit participants from RIDOC, which has a long-standing MOUD program. Eligible participants are incarcerated individuals with upcoming release dates that express interest in XR-B and have no contraindications to treatment.
INTERVENTION Participants will receive either Sublocade or Brixadi based on their assignment. Interventions will be provided monthly. Participants are allowed to change treatments or discontinue any time.
OUTCOME MEASURES
The study will assess implementation, service, and client outcomes based on the Proctor et al. framework:
- Implementation Outcomes (acceptability, feasibility, appropriateness, fidelity) Acceptability: Initial treatment preferences, in-facility retention, and the Acceptability of Intervention Measure (AIM). Feasibility: Feasibility of Intervention Measure (FIM) and study enrollment rates. Appropriateness: Intervention Appropriateness Measure (IAM). Fidelity: Proportion of XR-B doses administered within the appropriate dosing window (26-35 days).
- Service Outcomes (effectiveness, safety, equity) Effectiveness: Post-release retention in MOUD treatment Safety: Incidence of adverse events associated with XR-B administration.
- Client Outcomes (satisfaction, function, symptomatology) Treatment Satisfaction: Modified Treatment Satisfaction Questionnaire (TSQM-9). Opioid Use: Self-reported opioid use and urine toxicology screens (with missing tests assumed positive).
Health Service Utilization: Emergency department visits and hospitalizations (tracked via electronic health records).
Cravings: Opioid Craving Visual Analog Scale (OC-VAS).
SAMPLE SIZE This is a pilot study with a target enrollment of 60 participants (30 per treatment arm).
DATA COLLECTION Data Sources: Data will be collected through self-reported surveys, clinical records, urine toxicology tests, and statewide administrative databases (including the Rhode Island Prescription Drug Monitoring Program).
Data Security: All identifiable information will be stored in a secure, HIPAA-compliant system with restricted access.
STATISTICAL ANALYSIS PLAN Primary Analysis: Logistic regression will be used to compare treatment retention across study arms.
Secondary Analyses: Feasibility, acceptability, and safety outcomes will be analyzed using ordinal logistic regression (e.g., AIM, FIM, IAM). Kaplan-Meier survival curves will assess time-to-treatment discontinuation. Generalized estimating equations (GEE) will be used to model repeated measures outcomes such as opioid cravings and treatment satisfaction over time. Differences in treatment satisfaction and opioid use will be analyzed using linear regression for continuous variables and logistic regression for binary variables.
Sensitivity Analysis: Sensitivity analyses will include intent-to-treat (ITT), per-protocol (PP), and modified intent-to-treat (mITT) approaches. ITT analysis will include all randomized participants in their assigned groups, regardless of treatment adherence. PP analysis will focus on participants who complete at least two months of XR-B post-release to assess effectiveness among those who adhere to treatment. The mITT analysis will exclude participants who become ineligible due to changes in release dates post-enrollment to better estimate true treatment effects. Multiple imputation will be used for missing data, and additional sensitivity analyses will assess the robustness of findings across different assumptions regarding missingness.
SAFETY MONITORING AND ADVERSE EVENTS Adverse events (AEs) and serious adverse events (SAEs) will be monitored using the Systematic Assessment for Treatment Emergent Events (SAFTEE) framework. A Data and Safety Monitoring Board (DSMB) will oversee study progress and participant safety. All unanticipated problems, protocol deviations, and safety concerns will be reported to the Brown University Health IRB and RIDOC Medical Review Board.
LIMITATIONS As a pilot study, this study is not powered to detect small differences in effectiveness. Findings may not generalize beyond Rhode Island's correctional system. Findings will inform a larger, multi-site hybrid trial evaluating XR-B formulations in diverse correctional settings.
- Being tested
- Brixadi (Injectable Buprenorphine), Sublocade
- Keywords
- opioid use disorder, incarceration, prison, long-acting injectable, buprenorphine, XR-B
- 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.
Brixadi (Injectable Buprenorphine)Drug
Also called CAM2308, Buvidal
Brixadi comes in several doses and can be administered on a weekly or monthly basis. For clinical reasons (i.e., each patient will already be on a stable dose of MOUD in a setting without significant illicit opioid use), the monthly injection will be used. The approximately equivalent to the 300mg Sublocade dose is 96mg of Brixadi. The maximum dose is 128mg. Brixadi can be administered in the abdomen, buttocks, or triceps. Participants in the Brixadi treatment arm will be given one or more Brixadi injections each month prior to release from prison and each month after release. They can continue to receive the medication after the conclusion of the trial. Brixadi is covered by most Medicaid health insurances in the state of Rhode Island.
SublocadeDrug
Sublocade is a 100mg or 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. Participants in the Sublocade treatment arm will be given monthly Sublocade injections, as clinically indicated, each month prior to release from prison and each month after release. They can continue to receive the medication after the conclusion of the trial. Sublocade is covered by most Medicaid health insurances in the state of Rhode Island. The standard dosing schedule is two months of 300mg followed by monthly 100mg injections. To maximize real-world generalizability, the medication dosing will be determined by clinical indication of the provider who will have the flexibility to provide medication dosing based on their clinical acumen and/or shared decision-making.
| Study group | Role | What they receive |
|---|---|---|
| Sublocade | Active comparator | Participants receive Sublocade-branded injectable buprenorphine. Receives: Drug: Sublocade |
| Brixadi | Active comparator | Participants receive Brixadi-branded injectable buprenorphine. Receives: Drug: Brixadi (Injectable Buprenorphine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary Effectiveness
Preliminary Effectiveness will be measured through rates of community treatment continuation post-release. Outpatient treatment engagement over the first three months post-release will be assessed using study records of CPC Recovery Clinic follow-up appointments. For patients that do not follow at the CPC Recovery Clinic, statewide administrative data from the Rhode Island Prescription Drug Monitoring Program (PDMP) database covering community pharmacy fills of buprenorphine products will be used to supplement treatment retention outcomes. PDMP data will also be used to track community treatment continuation for all participants from three to six months post-release. Participants will be logged as continuing buprenorphine treatment at each month if: (1) CPC Recovery Clinic records show that they were present at their scheduled follow-up visit, or (2) the PDMP indicates that they continued treatment elsewhere and have not had a gap of more than 30 days in dispensed medication.
Measured: 3 months post-release
Implementation Outcomes: Acceptability
Acceptability will be measured through initial patient preference, in-facility treatment retention, and the validated Acceptability of Intervention Measure (AIM).
The Acceptability of Intervention Measure (AIM) assesses the extent to which an intervention is perceived as satisfactory or agreeable by stakeholders. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater acceptability of the intervention.
Measured: Baseline, Immediately after the intervention
Implementation Outcomes: Feasibility
Feasibility will be measured by the validated Feasibility of Intervention Measure (FIM) and enrollment rates.
The Feasibility of Intervention Measure (FIM) evaluates the degree to which an intervention can be successfully used or implemented within a given setting. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater feasibility of implementing the intervention.
Measured: Baseline, Immediately after the intervention
Implementation Outcomes: Appropriateness
Appropriateness will be measured by the validated Intervention Appropriateness Measure (IAM).
The Appropriateness of Intervention Measure (IAM) measures how well an intervention fits with the setting, needs, or problem it is intended to address. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater perceived appropriateness of the intervention.
Measured: Baseline, Immediately after the intervention
Implementation Outcomes: Fidelity
Fidelity will be measured by the proportion of doses administered within the 26-35 day range of appropriate dosing cadence.
Measured: Baseline, Immediately after the intervention
Secondary outcomes (5)
Client Outcomes: Satisfaction
Treatment Satisfaction will be assessed using a modified version of the previously validated Treatment Satisfaction Questionnaire for Medication (TSQM-9) after each in-facility injection.
TSQM scoring is by domain and each domain score is computed by summing the individual TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, 100 as highly satisfied.
Measured: During the intervention
Client Outcomes: Function - Healthcare Utilization
Healthcare utilization will be assessed using emergency department or hospital visits will be tracked using Rhode Island Hospital CPC Recovery Clinic Electronic Medical Record data.
Measured: During the intervention
Client Outcomes: Function - Recidivism
Reincarceration will be tracked using RIDOC administrative data identifying return to jail or prison.
Measured: During the intervention, 3 months after the intervention
Client Outcomes: Treatment Satisfaction
Treatment Satisfaction will be assessed using a modified version of the previously validated Treatment Satisfaction Questionnaire for Medication (TSQM-9) after each in-facility injection.
Measured: During the intervention
Client Outcomes: Function - Return to Use
Illicit opioid abstinence will be assessed through urine toxicology screening at each CPC Recovery Clinic follow-up appointment.
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start18 Feb 2026
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifespan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Justin Berk, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880718
- Sponsor's protocol ID
- IRB 2210402
- Other IDs
- K23DA055695
- Status last verified
- May 2026
- First submitted
- 5 Mar 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After all data have been collected and study results have been published, de-identified data will be made available to other qualified researchers upon request. Each data request will be evaluated by the PI to ensure that it meets reasonable standards of scientific integrity. The researchers have carefully selected standardized and widely-used assessments to promote data sharing and integration into larger databases and to allow other researchers the ability to analyze the data, including by conducting meta-analyses. The researchers will submit primary results for publication by the end of the project period and will have final de-identified datasets available within six months of the end of the project period.
Publications
Berk J, Cook M, Martin M, Lee JD, Koinis-Mitchell D, Brinkley-Rubinstein L, Drainoni ML, Rich J. Injectable buprenorphine during transition out of prison: A pilot partially randomized preference trial protocol. Contemp Clin Trials. 2025 Sep;156:108004. doi: 10.1016/j.cct.2025.108004. Epub 2025 Jul 9.
PubMed 40645369
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injectable Buprenorphine During Transition Out of Prison: A Partially Randomized Preference Pilot Trial
- ClinicalTrials.gov ID
- NCT06880718
- Acronym / sponsor ID
- IRB 2210402
- Keywords
- opioid use disorder, incarceration, prison, long-acting injectable, buprenorphine, XR-B
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- LifespanUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Mar 2025 (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.
The goal of this pilot trial is to compare two branded extended-release buprenorphine (XR-B) formulations (Sublocade vs. Brixadi) to explore how they improve treatment retention after release from prison among incarcerated individuals with opioid use disorder (OUD) who are transitioning back into the community.
The main question it aims to answer are:
How do Sublocade and Brixadi compare in terms of feasibility, acceptability, and effectiveness? Does giving people a choice of medication affect how well they stay in treatment?
Using a partially randomized preference trial approach, there will be a comparison between participants who choose their XR-B formulation to those who are randomly assigned to see if patient preference influences treatment outcomes. The trial is a hybrid implementation-effectiveness trial.
Participants will:
- Choose which medication they prefer or be randomly assigned if they don't have a preference.
- Receive monthly injections of either Sublocade or Brixadi before and after release from prison.
- Complete surveys and clinical assessments on treatment experience and acceptability.
- Be monitored for treatment retention, opioid use, and adverse events for six months post-release.
Researchers will compare the two treatments to see which one works better for people leaving prison and if allowing people to choose their treatment improves results.
Detailed description
This study is a pilot hybrid effectiveness-implementation trial using a partially randomized preference trial (PRPT) design to evaluate two formulations of extended-release buprenorphine (XR-B)-Sublocade and Brixadi-for the treatment of opioid use disorder (OUD) in individuals transitioning from prison to the community. The study is being conducted in collaboration with the Rhode Island Department of Corrections (RIDOC) to assess treatment retention, feasibility, and acceptability and other implementation outcomes in a carceral setting.
STUDY OBJECTIVES As a hybrid trial, the study will assess effectiveness and implementation outcomes. The primary objective of this study is to compare effectiveness (post-release treatment retention) among participants who receive Sublocade or Brixadi before and after release from prison. The study also aims to evaluate the impact of patient preference on treatment outcomes, including differences in retention between those who choose their treatment and those who are randomized. The study will also assess implementation outcomes including feasibility, acceptability, and fidelity.
STUDY DESIGN This is a pilot hybrid effectiveness-implementation trial that incorporates a partially randomized preference trial (PRPT) design.
Participants with a clear preference for either Sublocade or Brixadi will receive their preferred treatment. Participants with no strong preference will be randomized 1:1 using a stratified block randomization approach, stratified by gender, with blocks of four. Randomization assignments will be concealed using opaque sealed envelopes. The study is open-label, meaning both participants and study staff will be aware of treatment assignments. Given the preference-based design, blinding is not feasible.
STUDY SETTING The study will recruit participants from RIDOC, which has a long-standing MOUD program. Eligible participants are incarcerated individuals with upcoming release dates that express interest in XR-B and have no contraindications to treatment.
INTERVENTION Participants will receive either Sublocade or Brixadi based on their assignment. Interventions will be provided monthly. Participants are allowed to change treatments or discontinue any time.
OUTCOME MEASURES
The study will assess implementation, service, and client outcomes based on the Proctor et al. framework:
- Implementation Outcomes (acceptability, feasibility, appropriateness, fidelity) Acceptability: Initial treatment preferences, in-facility retention, and the Acceptability of Intervention Measure (AIM). Feasibility: Feasibility of Intervention Measure (FIM) and study enrollment rates. Appropriateness: Intervention Appropriateness Measure (IAM). Fidelity: Proportion of XR-B doses administered within the appropriate dosing window (26-35 days).
- Service Outcomes (effectiveness, safety, equity) Effectiveness: Post-release retention in MOUD treatment Safety: Incidence of adverse events associated with XR-B administration.
- Client Outcomes (satisfaction, function, symptomatology) Treatment Satisfaction: Modified Treatment Satisfaction Questionnaire (TSQM-9). Opioid Use: Self-reported opioid use and urine toxicology screens (with missing tests assumed positive).
Health Service Utilization: Emergency department visits and hospitalizations (tracked via electronic health records).
Cravings: Opioid Craving Visual Analog Scale (OC-VAS).
SAMPLE SIZE This is a pilot study with a target enrollment of 60 participants (30 per treatment arm).
DATA COLLECTION Data Sources: Data will be collected through self-reported surveys, clinical records, urine toxicology tests, and statewide administrative databases (including the Rhode Island Prescription Drug Monitoring Program).
Data Security: All identifiable information will be stored in a secure, HIPAA-compliant system with restricted access.
STATISTICAL ANALYSIS PLAN Primary Analysis: Logistic regression will be used to compare treatment retention across study arms.
Secondary Analyses: Feasibility, acceptability, and safety outcomes will be analyzed using ordinal logistic regression (e.g., AIM, FIM, IAM). Kaplan-Meier survival curves will assess time-to-treatment discontinuation. Generalized estimating equations (GEE) will be used to model repeated measures outcomes such as opioid cravings and treatment satisfaction over time. Differences in treatment satisfaction and opioid use will be analyzed using linear regression for continuous variables and logistic regression for binary variables.
Sensitivity Analysis: Sensitivity analyses will include intent-to-treat (ITT), per-protocol (PP), and modified intent-to-treat (mITT) approaches. ITT analysis will include all randomized participants in their assigned groups, regardless of treatment adherence. PP analysis will focus on participants who complete at least two months of XR-B post-release to assess effectiveness among those who adhere to treatment. The mITT analysis will exclude participants who become ineligible due to changes in release dates post-enrollment to better estimate true treatment effects. Multiple imputation will be used for missing data, and additional sensitivity analyses will assess the robustness of findings across different assumptions regarding missingness.
SAFETY MONITORING AND ADVERSE EVENTS Adverse events (AEs) and serious adverse events (SAEs) will be monitored using the Systematic Assessment for Treatment Emergent Events (SAFTEE) framework. A Data and Safety Monitoring Board (DSMB) will oversee study progress and participant safety. All unanticipated problems, protocol deviations, and safety concerns will be reported to the Brown University Health IRB and RIDOC Medical Review Board.
LIMITATIONS As a pilot study, this study is not powered to detect small differences in effectiveness. Findings may not generalize beyond Rhode Island's correctional system. Findings will inform a larger, multi-site hybrid trial evaluating XR-B formulations in diverse correctional settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublocade | Active comparator | Drug: SublocadeParticipants receive Sublocade-branded injectable buprenorphine. |
| Brixadi | Active comparator | Drug: Brixadi (Injectable Buprenorphine)Participants receive Brixadi-branded injectable buprenorphine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- be at least 18 years of age and incarcerated in the RIDOC facility,
- be currently diagnosed with OUD and enrolled in the RIDOC MOUD program,
- have an expected release date within 120 days of study enrollment,
- have an interest in XR-B and
- be English speaking
Key exclusion criteria (4 listed)
- individuals who are pregnant or planning conception,
- diagnosed with a severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely,
- have a release date within 21 days of initiation, or
- have previously had an allergy to buprenorphine. Post-enrollment exclusion will include individuals if there is a change in release date beyond the 120 days and therefore no longer meet original inclusion criteria. These individuals would return to usual MOUD care.
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 |
|---|---|---|
| Brixadi (Injectable Buprenorphine)Also: CAM2308, BuvidalBrixadi comes in several doses and can be administered on a weekly or monthly basis. For clinical reasons (i.e., each patient will already be on a stable dose of MOUD in a setting without significant illicit opioid use), the monthly injection will be used. The approximately equivalent to the 300mg Sublocade dose is 96mg of Brixadi. The maximum dose is 128mg. Brixadi can be administered in the abdomen, buttocks, or triceps. Participants in the Brixadi treatment arm will be given one or more Brixadi injections each month prior to release from prison and each month after release. They can continue to receive the medication after the conclusion of the trial. Brixadi is covered by most Medicaid health insurances in the state of Rhode Island. | Drug | Brixadi |
| SublocadeSublocade is a 100mg or 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. Participants in the Sublocade treatment arm will be given monthly Sublocade injections, as clinically indicated, each month prior to release from prison and each month after release. They can continue to receive the medication after the conclusion of the trial. Sublocade is covered by most Medicaid health insurances in the state of Rhode Island. The standard dosing schedule is two months of 300mg followed by monthly 100mg injections. To maximize real-world generalizability, the medication dosing will be determined by clinical indication of the provider who will have the flexibility to provide medication dosing based on their clinical acumen and/or shared decision-making. | Drug | Sublocade |
Primary outcome
Preliminary Effectiveness
Time frame: 3 months post-release
Preliminary Effectiveness will be measured through rates of community treatment continuation post-release. Outpatient treatment engagement over the first three months post-release will be assessed using study records of CPC Recovery Clinic follow-up appointments. For patients that do not follow at the CPC Recovery Clinic, statewide administrative data from the Rhode Island Prescription Drug Monitoring Program (PDMP) database covering community pharmacy fills of buprenorphine products will be used to supplement treatment retention outcomes. PDMP data will also be used to track community treatment continuation for all participants from three to six months post-release. Participants will be logged as continuing buprenorphine treatment at each month if: (1) CPC Recovery Clinic records show that they were present at their scheduled follow-up visit, or (2) the PDMP indicates that they continued treatment elsewhere and have not had a gap of more than 30 days in dispensed medication.
Implementation Outcomes: Acceptability
Time frame: Baseline, Immediately after the intervention
Acceptability will be measured through initial patient preference, in-facility treatment retention, and the validated Acceptability of Intervention Measure (AIM). The Acceptability of Intervention Measure (AIM) assesses the extent to which an intervention is perceived as satisfactory or agreeable by stakeholders. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater acceptability of the intervention.
Implementation Outcomes: Feasibility
Time frame: Baseline, Immediately after the intervention
Feasibility will be measured by the validated Feasibility of Intervention Measure (FIM) and enrollment rates. The Feasibility of Intervention Measure (FIM) evaluates the degree to which an intervention can be successfully used or implemented within a given setting. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater feasibility of implementing the intervention.
Implementation Outcomes: Appropriateness
Time frame: Baseline, Immediately after the intervention
Appropriateness will be measured by the validated Intervention Appropriateness Measure (IAM). The Appropriateness of Intervention Measure (IAM) measures how well an intervention fits with the setting, needs, or problem it is intended to address. Scores are calculated using a 5-point Likert scale, where 1 = Completely Disagree and 5 = Completely Agree. The minimum possible score is 1, and the maximum possible score is 5. Higher scores indicate greater perceived appropriateness of the intervention.
Implementation Outcomes: Fidelity
Time frame: Baseline, Immediately after the intervention
Fidelity will be measured by the proportion of doses administered within the 26-35 day range of appropriate dosing cadence.
5 secondary outcomes
Client Outcomes: Satisfaction
Time frame: During the intervention
Client Outcomes: Function - Healthcare Utilization
Time frame: During the intervention
Client Outcomes: Function - Recidivism
Time frame: During the intervention, 3 months after the intervention
Client Outcomes: Treatment Satisfaction
Time frame: During the intervention
Client Outcomes: Function - Return to Use
Time frame: During the intervention
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 15 May 2026.
- Derived from this study: PubMed 40645369Berk J, Cook M, Martin M, Lee JD, Koinis-Mitchell D, Brinkley-Rubinstein L, Drainoni ML, Rich J. Injectable buprenorphine during transition out of prison: A pilot partially randomized preference trial protocol. Contemp Clin Trials. 2025 Sep;156:108004. doi: 10.1016/j.cct.2025.108004. Epub 2025 Jul 9.
- Individual participant dataSharing planned: Yes. After all data have been collected and study results have been published, de-identified data will be made available to other qualified researchers upon request. Each data request will be evaluated by the PI to ensure that it meets reasonable standards of scientific integrity. The researchers have carefully selected standardized and widely-used assessments to promote data sharing and integration into larger databases and to allow other researchers the ability to analyze the data, including by conducting meta-analyses. The researchers will submit primary results for publication by the end of the project period and will have final de-identified datasets available within six months of the end of the project period.
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Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Opioid Use Disorder, Alcohol Intoxication
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)
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
RecruitingObservational study
Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
Opioid-Related Disorders, Drug Addiction
Active, not recruiting
Facilitating Opioid Care Connections
Opioid Court Model, Medication to Treat 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.
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 Brixadi (Injectable Buprenorphine) and Sublocade in people with Opioid Use Disorder and Incarceration, run by Lifespan 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 4 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 15 May 2026. 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?
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 Justin Berk, MD MPH MBA ((401) 680-1074, justin_berk@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary Effectiveness (time frame: 3 months post-release). The study lists 5 primary outcomes in all. 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 NCT06880718, which also lists 1 linked publication.
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 15 May 2026.