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Principal Investigator: Justin Berk
Organization: RHODE ISLAND HOSPITAL
Fiscal Year: 2024
Award: $65,365
Funding agency: National Institute on Drug Abuse
PROJECT SUMMARY
This K23 application proposes novel research in opioid use disorder (OUD) treatment in a correctional
healthcare setting and a robust training plan to support the successful transition of the Dr. Justin Berk, MD
MPH MBA (PI) to independent clinician-scientist. His background in public health, health management, and
clinical medicine creates a strong foundation for further development as an expert scientist. He has assembled
a highly accomplished and diverse team of nationally recognized mentors and advisors with complementary
expertise in clinical trials and other research among vulnerable populations including qualitative methodologies
and implementation science. The proposed research work will provide hands-on experience instrumental to Dr.
Berk’s career progression as a clinical trialist preliminary data for a future multi-site R01 application. The
Rhode Island Department of Corrections (RIDOC) is an ideal setting for this type of pilot study.
Medications for opioid use disorder (MOUD) are an effective treatment in the community and among
incarcerated individuals. Given the high prevalence OUD in jails and prisons and the high risk of opioid
overdose upon release, the criminal justice (CJ) system offers a targeted opportunity to engage individuals in
treatment initiation. Despite the strong evidence-base for MOUD, few correctional facilities offer these life-
saving medications. A shifting policy landscape in legislation and court rulings will lead to more facilities
offering MOUD treatment. Delivery barriers, however, still exist. A new injectable extended-release form of
buprenorphine (XR-B) can help overcome these barriers, though there is no published literature on its
effectiveness or implementation in a CJ setting. This K23 proposes a randomized controlled trial (RCT) to
demonstrate preliminary effectiveness, acceptability, and feasibility of XR-B and uses a concomitant process
evaluation, with frameworks frequently used in implementation science, to investigate how this novel treatment
modality may be used in a CJ setting to prevent opioid overdose in the high-risk time of re-entry to the
community.
The specific aims of this K23 proposal include: (Aim 1) Compare XR-B initiation to treatment-as-usual
sublingual buprenorphine among incarcerated individuals on treatment engagement, re-incarceration,
overdose, buprenorphine adherence, and illicit opioid use. (Aim 2) Conduct a process evaluation using the RE-
AIM evaluative framework and iPARIHS implementation science framework to assess the implementation of
XR-B initiation and identify facilitators to and barriers of MOUD treatment in a CJ setting.
In order to achieve these aims and move towards research independence, Dr. Berk will receive training
and experience in clinical trial research, including supporting qualitative methodologies and implementation
science, and build a career to conduct high-impact and ethical research in a marginalized population.
Terms: <Active Follow-up><Address><Adherence><Assess implementation><Buprenorphine><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Caring><Cessation of life><Clinical><Clinical Medical Sciences><Clinical Medicine><Clinical Trials><Communities><Correctional Institutions><Criminal Justice><Data><Data Bases><Data Set><Databases><Death><Dedications><Development><Disparities><Disparity><Dropout><Drug Screening><Drugs><Effectiveness><Enrollment><Epidemic><Ethics><Evaluation><Event><Familiarity><Foundations><Funding><Future><General Population><General Public><Goals><Grant><High Prevalence><Implementation assessment><Imprisonment><Individual><Injectable><Institution><Intervention><Intervention Strategies><Interview><Investigators><Jail><Legislation><Life><Link><Literature><Measures><Medication><Mentors><Methodology><Methods><Modality><Monitor><NIH><National Institutes of Health><Overdose><Parents><Patients><Persons><Pharmaceutical Preparations><Pilot Projects><Policies><Population><Prisons><Public Health><Publishing><RE-AIM><Randomized, Controlled Trials><Reach, Effectiveness, Adoption, Implementation, and Maintenance><Research><Research Personnel><Research Resources><Researchers><Resources><Rhode Island><Risk><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Sampling><Scientist><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Site><Standardization><Statutes and Laws><Survey Instrument><Surveys><System><Time><Training><Treatment outcome><United States National Institutes of Health><Urine><Vulnerable Populations><Work><active followup><addiction><addictive disorder><barriers to implementation><care as usual><career><cohort><community setting><compare treatment><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><cost><court><data base><developmental><disparities in race><disparity due to race><drug/agent><effective therapy><effective treatment><effectiveness clinical trial><enroll><ethical><evaluate implementation><evaluation of implementation><evidence base><experience><facilitators to implementation><follow up><follow-up><followed up><followup><health care management><health care settings><health management><healthcare management><healthcare settings><high risk><illicit opiate><illicit opioid><implementation barriers><implementation challenges><implementation evaluation><implementation facilitators><implementation framework><implementation outcomes><implementation research framework><implementation science><implementation science framework><incarcerated><incarceration><inequality due to race><inequity due to race><interest><interventional strategy><marginalized group><marginalized individual><marginalized people><marginalized population><medication for opioid use disorder><mortality><novel><opiate consumption><opiate deaths><opiate drug use><opiate intake><opiate mortality><opiate overdose><opiate related overdose><opiate use><opiate use disorder><opioid consumption><opioid deaths><opioid drug overdose><opioid drug use><opioid induced overdose><opioid intake><opioid intoxication><opioid medication overdose><opioid mortality><opioid overdose><opioid overdose death><opioid poisoning><opioid related death><opioid related overdose><opioid toxicity><opioid use><opioid use disorder><parent><patient centered><patient oriented><pilot study><prevent><preventing><primary outcome><process evaluation><programs><race based disparity><race based inequality><race based inequity><race disparity><race related disparity><race related inequality><race related inequity><racial disparity><racial inequality><racial inequity><racially unequal><randomized control trial><reach, efficacy, adoption, implementation, and maintenance><reincarceration><secondary outcome><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><skills><social stigma><stigma><treatment as usual><treatment center><treatment comparison><trial comparing><uptake><usual care><vulnerable group><vulnerable individual><vulnerable people>