Center for Addiction Research, Education, and Service (CARES)

Nalini Negi, Ph.D., MSW, Associate Professor, University of Maryland School of Social Work, Principal Investigator
Wendy Camelo Castillo, MD MSc Ph.D., Assistant Professor, University of Maryland School of Pharmacy, Co-Principal Investigator
Fernando Wagner, Sc.D., MPH, Professor, University of Maryland School of Social Work, Co-Principal Investigator

Project Description: Latinos who are mostly foreign-born and monolingual are among the fastest-growing groups in Baltimore. With CARES funding, we will gather important Phase I pilot data for a NIH R01 proposal to implement a larger research program to build an integrated system of care for under-insured or uninsurable substance-using Latino im/migrants (LM). Using Community Based Participatory Research (CBPR) principles, six focus groups with LM and six with behavioral health specialists (BHS) will be conducted to elucidate barriers and facilitators to SUD services in Baltimore. Next, a Community Advisory Board (CAB) consisting of LM and BHS will co-initiate the building of a “system of care” approach for substance-using underinsured, and uninsurable Latino immigrants in Baltimore. This application represents an important step toward decreasing health disparities among an extremely vulnerable and underserved population, Latino immigrants. 

Brook W. Kearley, Ph.D. Research Assistant Professor, University of Maryland School of Social Work, Principal Investigator 
Annabelle M. Belcher, Ph.D., Assistant Professor, University of Maryland School of Medicine, Co-Investigator 
Alexandra Wimberly, Ph.D. Assistant Professor, University of Maryland School of Social Work, Co-Investigator

Project Description: This qualitative study will assess potential barriers to staff acceptability of medication for opioid use disorder (MOUD) programs in detention centers.  Study aims include A1a. Assess staff acceptance of soon-to-be-implemented MOUD programs at four geographically diverse Maryland jails; A1b: Assess for types of stigmas held by these staff, including (1) perceptions of MOUD efficacy, (2) attitudes towards MOUD, and (3) stigma against people who use opioids (PWUO); A2. Assess any differences in perceptions and attitudes towards MOUD and PWUO between various levels of staff in these detention center settings (leadership, line officer, health/medical, discharge coordination staff) across the sites; and A3. Assess the feasibility of a staff-tailored training intervention designed to address barriers to MOUD acceptability. 

Bethany DiPaula, Pharm.D., BCPP, FASHP, Professor, University of Maryland School of Pharmacy, Principal Investigator 
Catherine Cooke, PharmD, MS, BCPS, PAHM, Research Associate Professor, University of Maryland School of Pharmacy, Principal Investigator

Project Description: Inadequate access to medications for opioid use disorder (OUD) contributes to undertreatment and has been exacerbated by the COVID pandemic. Variable pharmacy access to buprenorphine has been raised as a local and national issue, yet data on the extent of this problem, contributing factors, and solutions are limited and conflicting. This project will assess the availability of buprenorphine/naloxone in Maryland community pharmacies and real-world obstacles that pharmacists face when stocking and dispensing this medication for the treatment of OUD. Based on the findings, the researchers will propose targeted strategies to address the obstacles. The goal is to improve treatment access and care for individuals with OUD.

Max Spaderna, MD, Assistant Professor, University of Maryland School of Medicine, Principal Investigator 
Charles Callahan, DO, Adjunct Professor, University of Maryland School of Medicine, Co-Principal Investigator 
Aaron D. Greenblatt, MD, Assistant Professor, University of Maryland School Medicine, Co-Principal Investigator 
Samuel B. Little, Ph.D., Clinical Associate Professor, University of Maryland School of Social Work, Co-Principal Investigator 

Project Description: Providing permanent housing benefits homeless individuals with opioid use disorder, but this is often difficult to provide, The Social Work Assistance and Stipends for Housing (SASH) study will give six months of housing stipends that can be used for a broad range of temporary housing options to homeless individuals receiving methadone for opioid use disorder treatment. These stipends will be accompanied by 12 months of Social Work assistance aimed at finding permanent housing for the participants. The purpose of SASH is to determine whether these interventions will improve outcomes for housing, quality of life, opioid use disorder, and methadone treatment.

Michelle Tuten, Ph.D., MSW, Associate Professor, School of Social Work, Principal Investigator
Aaron Greenblat, MD, Assistant Professor, Scool of Medicine, Co-Principal Investigator 
Eric Weintraub, MD, Associate Professor, School of Medicine, Co-Principal Investigator

The proposed study represents phase I of a multi-phase research plan to develop a smoking cessation intervention tailored to the specific needs of a population enrolled in OUD treatment. Phase I consists of a survey study of the demographic characteristics and smoking behaviors of patients enrolled in OUD treatment at baseline, and an initial efficacy trial for N=20 participants randomly assigned to receive smoking cessation medications combined with contingency management (CM) for daily medication ingestion (Enhanced smoking cessation [ESC: n=10]) or usual care (UC: n=10). These data will help us determine the population’s level of interest in smoking cessation intervention and provide initial data on whether enhanced care shows promise as a smoking reduction intervention. 

Specific Aims: 
AIM 1. To assess the demographic and smoking behaviors of N=50 patients enrolled in OUD treatment at baseline.  
AIM 2a. To compare participants randomly assigned to receive ESC or UC on demographic and smoking behaviors at baseline and 1, 3, and 6 months post-treatment (AIM 1).
AIM 2b. to assess the initial efficacy of ESC (n=10) relative to UC (n=10) on a proportion of the population who fill a prescription for smoking cessation medications, self-reported smoking quantity and frequency, self-reported NRT use, carbon monoxide levels, and substance use at 1, 3, and 6 months post-treatment enrollment.  
AIM 3. To assess the level of medication adherence (medication ingestion/scheduled observation sessions) for ESC participants.  

Annabelle M. Belcher, Ph.D., Assistant Professor, School of Medicine, Principal Investigator 
Todd Gould, MD, Professor, School of Medicine, Co-Principal Investigator
Eric Weintraub, MD, Associate Professor, School of Medicine, Co-Principal Investigator
Sarah Kattakuzhy, MD, Assistant professor, School of Medicine, Co-Principal Investigator

Methadone is a first-line, evidence-based treatment for opioid use disorder (OUD). Unfortunately, retention and adherence in methadone treatment is a major challenge. OUD patients frequently present with co-morbid depression (OUDCD), a risk factor for poor OUD treatment outcomes, overdose, and suicide. The last two decades have seen an exciting and transformational development in the treatment of depression – ketamine. As a safe, rapid-acting anti-depressant deliverable within the context of methadone maintenance treatment, ketamine could feasibly change the landscape of treatment for OUD patients with comorbid depression. This proposal seeks to evaluate implementation outcomes (feasibility and patient acceptance) as well as preliminary efficacy of ketamine on methadone treatment outcomes for OUD patients with comorbid depression and depressive symptoms presenting for methadone treatment.

Specific Aims:
SA1: Assess the feasibility and acceptance of a two-week regimen of sub- anesthetic antidepressant doses of ketamine as an adjunct to methadone in a racially diverse, low-income sample (n=6) of patients seeking treatment for opioid use disorder. 
SA2: Measure the impact of this ketamine dosing protocol on 1- and 3- month methadone maintenance treatment retention and depression.

Marik Moen, Ph.D., MPH, MSN, RN, Assistant Professor, School of Nursing, Principal Investigator
Max Spaderna, MD, Assistant Professor, School Of Medicine, Co-Principal Investigator 
Sarah Kattakuzhy, MD, Assistant Professor, School of Medicine, Co-Principal Investigator 
Aaron Greenblatt, MD, Assistant Professor, School of Medicine, Co-Principal Investigator

Substance use disorders (SUD) are among the greatest public health challenges facing the United States, resulting in millions of lives and billions of dollars lost. Improving research on SUD is necessary to address the public health crisis of substance misuse and disorders. Further, we recognize that successful employment and treatment for persons with SUD can prevent death and illness, but social determinants of health (e.g., housing, income, transportation, education) are barriers to treatment. As programs and employers seek to address these health-related social needs (HRSN), they are missing the stakeholder (patient, staff, and employer) perspective on how assessing unmet needs is viewed, what social needs are most relevant, and what to do about them. If we fail to grasp the stakeholder preferences and values, we miss opportunities to address critical problems, appropriately allocate resources, or adapt care/interventions for improved outcomes. To address the need for improved SUD research and lack of patient-centered approaches to addressing health-related social needs, the PURPLE and PEARL projects are collaborating to implement the following projects.

Improving Patient and Provider Engagement in Addiction Research Through A Longitudinal Research Collaborative - PEARL 
PEARL’s main objective to improve substance use research and incorporate the lived experience of individuals with substance use in the research process through the creation of a collaborative research council comprised of patients, staff, and investigators who will evaluate and develop addiction research. PEARL will consist of two interventions, the Research Advisory Council (RAC) and the Research Advisory Forum (RAF). The RAC will be comprised of investigators, staff, and patients of the ATP, and will meet quarterly to discuss and provide feedback on current protocols and various aspects of research including recruitment and compensation of study participants, study operations, study risks and benefits, promotion of justice and cultural relevance, and new ideas for substance use research projects. The semi-annual RAF open meeting will be led by patient RAC members as a forum to solicit feedback on several topics including making research projects more valid and meaningful to patients, addressing gaps in care that may inform the development of new investigations, and allowing Principal Investigators (PIs) to disseminate their research findings directly to the affected population.

Promoting Understanding in social needs Research Projects by Listening and Engagement - PURPLE 
PURPLE’s main objective is to help establish the PEARL RAC and then engage RAC members in guiding a qualitative research study. The PURPLE study seeks to gain firsthand expertise about the preferred methods of assessing, documenting, and addressing HRSN from persons with substance use disorders, from direct-service staff, and employers of persons with SUD. PURPLE will engage the PATIENTS program from the School of Pharmacy to facilitate implementation of the 10-Step Patient Engagement Framework and work with faculty from the Schools of Nursing, Social Work, and Medicine and ATP partners to implement the study. All interventions will be held at the University of Maryland Addiction Treatment Program (ATP), a certified substance use treatment program that collocates medical care, wellness programs, and research.

Bethany A. DiPaula, PharmD, BCPP, School of Pharmacy, Principal Investigator

Catherine E. Cooke, MS, PharmD, BCPS, PAHM, School of Pharmacy, Co-Principal Investigator

Project Goal

Expand access to medications for managing opioid use disorder (OUD) by establishing strategies for the financing of a physician-pharmacist collaborative model

Problem and Significance

Opioid use disorder (OUD) is a national emergency that requires additional resources to address. Evidence-based medications have been shown to decrease morbidity and mortality and increase treatment retention but are underused. The shortage of healthcare providers trained and available to manage patients with OUD medications contributes to undertreatment.

Employing new strategies and engaging all qualified healthcare professionals are key elements to increasing access to treatment for patients with OUD.  The physician-pharmacist collaborative model is an innovative solution to addressing workforce needs for patients with OUD. Utilizing pharmacists with extensive education and skills in medication management can reduce the resource gap in available care for patients with OUD. Close collaboration between prescribers and pharmacists can optimize medication selection, improve patient safety, and expand access to care. However, pharmacists do not have a traditional payment model to provide these services, which limits their ability to collaborate in non-acute care settings.

 Approach

Semi-structured interviews will be used to elicit third-party payer perspectives on expanding access to OUD medications through financing of physician-pharmacist collaborative model. A white paper will be produced describing the identified barriers and proposed solutions. A survey of the third-party payers will assess the impact of the White Paper.

Bradford Schwartz, MD, School of Medicine, Principal Investigator

Zach Dezman, MD, MS, School of Medicine, Co-Investigator

Christopher J. Welsh, MD, School of Medicine, Co-Investigator

Emergency Department-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) is emerging as an effective bridge to substance abuse treatment. The implementation of SBIRT via peer recovery coaches (PRC) is a relatively new phenomenon in the emergency department. PRC’s are typically non-professional community health educators, many of who are in long-term recovery themselves, who receive training in motivational interviewing. PRCs have successfully piloted ED-based SBIRT programs in many of the large-volume ED sites in the University of Maryland Medical System (UMMS) network, boasting improved linkage to care, 30-day retention rates, and higher patient satisfaction. Smaller ED’s with lower patient volumes and tighter budgets often do not have access to SBIRT. We evaluated the impact of a telemedicine model, utilizing Peer Recovery Coaches to deliver SBIRT, in two freestanding emergency departments. We hypothesized that the intervention of telemedicine to deliver SBIRT would be non-inferior to in-person communication in regard to patient referrals to outpatient substance abuse treatment as well as 30-day retention rates in treatment. Interestingly, this study occurred during the COVID pandemic. 

Sarah Kattakuzhy, M.D., School of Medicine, Principal Investigator

Maryland is among the top five states in the incidence of opioid-related deaths, with a rate of 32.2 deaths/100,000 persons, more than twice the national average. Despite the significant burden of disease attributable to opioid use disorder (OUD), and a wealth of data linking accessible treatment services to improved outcomes, implementation of evidence-based therapy remains poor. Barriers to the treatment of OUD exist at the patient, provider, and health system levels. However, stigma– both explicit and implicit- is the common driver of these barriers, reinforcing the gap between treatment need and uptake. Bias and poor education within the medical community serve to exacerbate this gap, limiting the number of patients who seek OUD care, and perpetuating the broken systems that reinforce addiction. To address the opioid epidemic, the healthcare workforce must not only expand but address stigma and bias through comprehensive, culturally-competent, interdisciplinary education in OUD.

The project Accelerating Interdisciplinary Resident Education in Opioid Use Disorder and Harm Reduction (AIROH) is an OUD education intervention to improve the knowledge and skills of residents on the front lines of the opioid epidemic and augment the physician workforce able to provide comprehensive, culturally-competent, and evidence-based care to patients with OUD. This initiative consists of two parallel interventions:

• OUD Primer: a didactic curriculum completed by every first-year (PGY-1) IM and FM resident at UMB, which includes longitudinal didactic education and buprenorphine waiver training.
• OUD Elective: an optional two-week elective that would provide an expanded didactic curriculum along with immersive clinical experience for second and third-year (PGY-2/3) IM and FM residents.

The project is led by a multidisciplinary team spanning the Departments of Medicine, Family & Community Medicine, and Psychiatry, including Drs. Sarah Kattakuzhy, Aaron Greenblatt, Dani Baek, Britt Gayle, and Elana Rosenthal.

To evaluate the success of the OUD Primer and OUD Elective interventions, all residents participating in the AIROH initiative will complete a survey entitled “Knowledge of and Attitude towards OUD” (KAO) before and after the OUD Primer or OUD Elective. The survey includes knowledge questions pertaining to diagnosis and management of OUD, as well as attitude questions, self-reflective assessments of bias and confidence in caring for individuals with OUD.

In 2020, the AIROH Program was initiated, conducting fall training sessions for PGY-1 FM and IM residents, including buprenorphine waiver training completion. Preliminary outcome data from the KAO was accepted for presentation at the American Society of Addiction Medicine 2021 conference. In 2021, we will complete didactic training, and hold the OUD Elective for PGY-2 and 3 residents. Beginning in July 2021, AIROH is poised to transition as a funded permanent training program, managed by the Maryland Addiction Consult Service, with expansion into the advanced practice provider and healthcare student populations- exemplifying the power of the CARES grant program.  

Jodi Jacobson Frey, PhD, MSW, LCSW-C, CEAP, School of Social Work, Co-Principal Investigator

Marianne Cloeren, MD, MPH, FACOEM, FACP, School of Medicine, Co-Principal Investigator

Although clinical outcomes are improved in patients with opioid use disorders who hold employment, many of these individuals do not work. This study seeks to provide valuable data for the multiphase interprofessional project, “Operation PROSPER – Peer Reintegration and Other Services Promoting Employment in Recovery”, which will identify and help to systematically overcome the barriers to employment faced by individuals receiving Medication Assisted Treatment (MAT) for Opioid Use Disorder (OUD) in University of Maryland clinics. More specifically, this study will concentrate on defining the gap in critical soft skills among adults receiving MAT; therefore, a focus will be on identifying areas needing improvement and support to prepare adults for interviews, to obtain jobs, and to sustain employment. This study has four aims, the first being to provide data on strengths and gaps in vocational soft skills using the ERS and perceived work disability using the World Health Organization Disability Assessment Schedule 2.0 among working-age patients receiving MAT and meeting inclusion criteria. The second aim is to assess, through focus groups with counselors and clinic administrators, and interviews with a sample of patients, the feasibility and potential benefit of using the ERS and customized ERS Action Planning tool as a prevocational service to support treatment offered at MAT programs for patients with OUD seeking employment.The third aim is to use asset mapping techniques to describe and summarize currently existing resources and partnerships throughout Baltimore City (and State of Maryland as appropriate) to meet the needs identified in the ERS Action Planning tool. Finally, the fourth aim is to compare results from the asset map to data collected from counselors, participants, and a sample of employers and workforce development program staff to identify gaps in resources and services identified as needs by the ERS Action Planning tool. The results of this study will produce much-needed information on strengths and gaps for obtaining and sustaining employment, with specific attention to soft skills and the needs of patients with OUD who are in recovery with MAT.

Zachary Dezman, MD, MS, School of Medicine, Principal Investigator

It has been reported that fentanyl positivity may paradoxically worsen withdrawal in patients undergoing buprenorphine induction in the emergency department (ED). In this study, we will determine the overall prevalence of fentanyl use, and then stratify these patients by complaint. It is hypothesized that patients who are positive for fentanyl and are undergoing buprenorphine induction in the ED will be more likely to suffer from episodes of worsening withdrawal, or require a prolonged induction (multiple small doses spaced over 6-8 hours), than those who are fentanyl-negative. This research will add to the current dearth of information related to the impact of fentanyl use.

Kristen Rawlett, PhD, FNP-BC, School of Nursing, Co-Principal Investigator

Alexandra Wimberly, PhD, MSW, MPH, School of Social Work, Co-Principal Investigator

This study addresses the following treatment gaps: 1.) the need for women- focused services for those with opioid use disorder (OUD); 2.) the need to understand factors that impact medication assisted treatment (MAT) adherence, and 3.) the need to understand whether mindfulness interventions are a feasible and acceptable intervention to address MAT adherence. Accordingly, the aims of this study are to first adapt an existing mindfulness intervention for use with MAT adherence. Through running focus groups with women receiving methadone, this study seeks to understand the strengths and challenges of women as it relates to MAT adherence; and incorporate this learning in the mindfulness curriculum. Second, we will pilot the adapted mindfulness intervention for MAT adherence with women who are receiving methadone and test its impact on MAT adherence and substance use. Finally, this study will assess predictors of MAT adherence by controlling for the effects of demographics, self-stigma and motivation on MAT adherence and conducting qualitative interviews to better understand determinants of MAT adherence.

Victoria Selby, PhD, CRNP, UMB School of Nursing, Co-Principal Investigator

Marc Fishman, Maryland Treatment Centers (MTC) Medical Director, Co-Principal Investigator

Kevin Wenzel, PhD, MTC Research Scientist, Clinical Psychologist, Investigator

The Youth Opioid Recovery Support (YORS) model is a promising, innovative, inter-professional, behavioral approach that attempts to address barriers to opioid treatment engagement in the vulnerable young adult population, especially difficulties with medication adherence. Components of YORS include assertive outreach, home-delivered medication administration, contingency management, and family engagement.  The purpose of this study is to evaluate a pilot enhancement of the YORS intervention in patients who have chosen either extended-release naltrexone or extended-release buprenorphine for treatment, use of standard reimbursement to cover clinical services, and transitioning back to clinic-based care after an intensive phase of home delivery. The first aim of this study is to evaluate feasibility and preliminary efficacy of the enhanced YORS intervention compared to recent historical data from a pilot RCT including both a YORS intervention group as a benchmark and a TAU group as a control, on the outcomes of doses of medication received, rates of opioid relapse, and total number of opioid positive urine tests. The second aim is to demonstrate the benefits of the enhanced YORS intervention in a pre-post evaluation using each participant as their own control, on the secondary outcomes of HIV risk behaviors, criminal behaviors, functional improvement, overdoses, and pattern of crisis services utilization. The third aim is to assess whether the intensive YORS intervention has the possibility of priming less intensive continuing care by measuring the rate of receipt of a clinic-based dose in the month following the last home-delivered dose. Thus, this study will glean key information that will be used to improve engagement and medication adherence for youth with OUD.

Mathangi Gopalakrishnan, MPharm, PhD, School of Pharmacy – Principle Investigator
Dina E. El-Metwally, MB, BCh, PhD, School of Medicine – Co-Investigator
Jessica Biggs, PharmD, BCPPS, UMMC – Co-Investigator
Megan Ehret, PharmD, MS, BCPP, School of Pharmacy – Co-Investigator
Vijay Ivaturi, MS, PhD, School of Pharmacy – Co-Investigator

Opioid use in pregnant mothers and its sequelae among their infants leading to neonatal abstinence syndrome (NAS) is a major public health concern in the United States (US).  Current treatment recommendations are often empiric dosing of morphine or methadone and most follow intuition-based approaches that could potentially lead to increased lengths of hospital stay (LOS) and add to economic burden.  The purpose of this study is to develop an adaptive-individualized dosing strategy (clinical decision support system) for morphine that can guide real-time NAS therapeutic decisions in a clinical setting. The specific aims of the research include: (i) design and conduct of a retrospective cohort study to collect data on infants with NAS admitted to the UMMC, NICU between 2013 and 2017, (ii) utilize advanced data analytical methodologies to develop and validate an adaptive-individualized morphine dosing strategy using the UMMC data and (iii) develop a prototype clinician friendly web-based application that can provide the individualized morphine dosing recommendations in real time.  The proposed collaborative translational research between UMB-SOP, UMB-SOM and UMMC is envisaged to assist clinicians to make informed individualized morphine dosing decisions, that can potentially lead to better clinical outcomes (reduced LOS) in infants suffering from NAS.  Efficient utilization of advancements in science and technology to improve NAS related patient care needs can inherently have a greater societal impact, serving both the baby and their mothers to lead healthier lives and reduce economic burden.

Sara B. Murthi, MD, School of Medicine – Principal Investigator
Luana Colloca, MD, PhD, School of Nursing – Principle Investigator

The purpose of this study is to validate innovative, inexpensive strategies to reduce opioid use in all aspects of trauma care. There are two main goals of this research study, the first is to establish a method of outpatient follow-up for the Relieving Traumatic Pain: A Pilot Study (RTP). The second goal is to develop a phone application with data collection and educational capabilities. Thus, the first aim of this study is to develop a phone application for data collection that can then be used to: (a.) collect long term outcome data related to pain severity, pain interference, and the use of opioids for RTP; and (b.) identify the risk factors associated with the risk of opioid dependence. The second aim is to create and assess a phone based educational tool in collaboration with clinical experts and beta test that tool with those admitted to the shock trauma center who are prescribed opioids and receive the educational tool in comparison those who do not receive the educational tool.

John Cagle, MSW, PhD, School of Social Work – Principal Investigator
Mary Lynn McPherson, MA, PharmD, School of Pharmacy – Co-Investigator
Paul Sacco, LCSW, PhD, School of Social Work – Co-Investigator
Jodi Frey, LCSW-C, PhD, School of Social Work – Co-Investigator

There is currently a dearth of knowledge related to how hospices monitor controlled medications in homes or facilities, and if, and how, these controlled medications are disposed of after an expected death. The purpose of this study is to address that gap in knowledge, and in turn help prevent substance misuse and diversion.  The first aim of the study is to provide national estimates on the prevalence of: (a.) drug diversion in hospice, both suspected and confirmed; (b.) opioids being left in the home after a patient death; and (c.) screening by hospice providers for patient/family risk of substance misuse or addiction. The second aim is to use qualitative survey data to describe and summarize: (a.) promising practices and policies that hospice providers are currently employing to prevent drug diversion; (b.) strategies to detect and respond when drug diversion occurs; and (c.) how to screen, and modify practice, for patients/families who are at risk for substance misuse or addiction. The findings will be used to create a list of best practice strategies and policies for hospice agencies on: (a.) drug diversion prevention and intervention; and (b.) the screening and treatment of patients/families at risk for substance misuse or addiction. Further, these will then be disseminated to hospices nationally to improve drug diversion prevention efforts, provide indicators and risk factors for diversion and recommend response strategies for when diversion occurs. The results will also inform future intervention research to improve drug diversion prevention efforts in hospice that, importantly, do not hamper pain management efforts.

The reference list is not included in the 5-page limit for the proposal.

Yes, faculty salaries are supported by SSG funding and should be included in the budget. Faculty requesting salary support should ensure that any salary support is approved by their respective school deans or department heads, as appropriate. 

There are no specified limits on the amount of salary support that can be requested.

The SSG proposal should specify the team's plans to apply for external funding and how the SSG pilot funding will enhance the team's prospect of obtaining future funding.