Opioid Use DisorderNCT06354465
Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: Qualitative Interviews
An observational study of Opioid Use Disorder and Criminal Justice, run by Lifespan at 1 site in United States.
Trial summary
This qualitative study investigates the potential benefits and challenges of using a once-a-month injectable medication, known as extended-release buprenorphine (XR-B), to treat individuals with opioid use disorder (OUD) within a correctional setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, Criminal Justice, Treatment Adherence and Compliance
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 1 Jul 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Incarcerated individuals include participants in the RIDOC MOUD program. Organizational stakeholders inlcude clinicians, Wardens, leadership and/or other staff involved in the MOUD program.
Incarcerated individuals, inclusion criteria:
- English speaking
- Over the age of 18
- Diagnosed with opioid use disorder
Incarcerated individuals, Exclusion Criteria:
- Diagnosed with "Severe, Persistent, Mental Illness (SPMI)" Rationale for Exclusion: These individuals suffer from severe mental health disease and therefore warrant greater protection, have greater risk for coercion, and offer insights to severe co-diagnosis treatment that, while important, remain outside the scope of general MAT implementation.
Organizational Stakeholders, Inclusion Criteria:
- Employed or contracted by Rhode Island Department of Corrections (for organizational staff interviews) and involved with the Medication for Addiction Treatment (MAT) program
Organizational Stakeholders, Exclusion Criteria:
- If not permitted by their organizational union to participate
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Department of Corrections
Cranston, Rhode Island, 02920
Jessica Migliaccio, 401-462-3921, doc.planning@doc.ri.gov
About this study
This qualitative study investigates the potential benefits and challenges of using a once-a-month injectable medication, known as extended-release buprenorphine (XR-B), to treat individuals with opioid use disorder (OUD) within a correctional setting. The research aims to understand if XR-B can be a feasible and effective alternative to the standard daily treatment and to identify which groups within the prison population may benefit the most from this treatment. In-depth interviews are conducted with incarcerated individuals and relevant stakeholders.
- Keywords
- addiction, criminal justice, Medications for opioid use disorder
- Medical subject headings
- Opioid-Related Disorders, Treatment Adherence and Compliance, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Incarcerated Individuals | Incarcerated individuals will be recruited across the Rhode Island Department of Corrections (RIDOC)facility during the required group sessions for treatment; this is consistent with previous NIH-funded studies at RIDOC. The interviews will be described and participants will be able to sign up confidentially. Participants who are eligible for Medications for Opioid Use Disorder (MOUD) but decide not to pursue treatment will still be interviewed to provide better understanding of the key factors that drive program participation. These individuals can be recruited through routine clinical care by addiction medicine providers. Every precaution will be taken to ensure confidentiality and protection of all participants. | |
| Stakeholders | Organizational stakeholders (clinicians, Wardens, leadership and/or other staff) will be recruited through snowball sampling. I will individually approach leaders of each facility to recruit correctional individuals interested in participating and will also allow participants to confidentially sign up at administrative meetings related to Medication for Addiction Treatment (MAT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Transcripts
A directed content analysis will identify key themes in structured interviews
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Jul 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 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, Lifespan
- Investigators
- Justin Berk, MD, Principal investigator, Lifespan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354465
- Sponsor's protocol ID
- IRB1967355
- Other IDs
- K23DA055695
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Given the sensitivity of data, some individual data may be censored but will be available to other researchers in aggregate.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: Qualitative Interviews
- ClinicalTrials.gov ID
- NCT06354465
- Acronym / sponsor ID
- IRB1967355
- Keywords
- addiction, criminal justice, Medications for opioid use disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- LifespanUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 9 Apr 2024 (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 qualitative study investigates the potential benefits and challenges of using a once-a-month injectable medication, known as extended-release buprenorphine (XR-B), to treat individuals with opioid use disorder (OUD) within a correctional setting. The research aims to understand if XR-B can be a feasible and effective alternative to the standard daily treatment and to identify which groups within the prison population may benefit the most from this treatment. In-depth interviews are conducted with incarcerated individuals and relevant stakeholders.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incarcerated Individuals | – | –Incarcerated individuals will be recruited across the Rhode Island Department of Corrections (RIDOC)facility during the required group sessions for treatment; this is consistent with previous NIH-funded studies at RIDOC. The interviews will be described and participants will be able to sign up confidentially. Participants who are eligible for Medications for Opioid Use Disorder (MOUD) but decide not to pursue treatment will still be interviewed to provide better understanding of the key factors that drive program participation. These individuals can be recruited through routine clinical care by addiction medicine providers. Every precaution will be taken to ensure confidentiality and protection of all participants. |
| Stakeholders | – | –Organizational stakeholders (clinicians, Wardens, leadership and/or other staff) will be recruited through snowball sampling. I will individually approach leaders of each facility to recruit correctional individuals interested in participating and will also allow participants to confidentially sign up at administrative meetings related to Medication for Addiction Treatment (MAT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Incarcerated individuals include participants in the RIDOC MOUD program. Organizational stakeholders inlcude clinicians, Wardens, leadership and/or other staff involved in the MOUD program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Qualitative Transcripts
Time frame: 1 year
A directed content analysis will identify key themes in structured interviews
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: Undecided. Given the sensitivity of data, some individual data may be censored but will be available to other researchers in aggregate.
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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.
Justin Berk, MD principal investigator
Lifespan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder and Criminal Justice, 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?
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: status not confirmed, as of the sponsor's last update on 9 Apr 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin Berk, MD (8064333960, justin_berk@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Transcripts (time frame: 1 year). 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 9 Apr 2024.