Current Studies

Affiliated Faculty: Sandra Springer, MD; Kevin Knight, PhD; Elisabeth Ank Nijhawan, MD
Funder: National Institute on Drug Abuse
Mechanism: U01
Period: 2020-2025

Improving HIV and opioid use disorder (OUD) management and implementation for criminal justice (CJ)- involved individuals requires effective approaches to screening, linkage and adherence to integrated services across community agencies and service providers. Addressing risk through Community Treatment for Infectious disease and Opioid use disorder Now (ACTION) among justice-involved populations is a 5-year Hybrid Type 1 Effectiveness- Implementation RCT that compares two models [Patient Navigation or Mobile Health Unit service delivery] of linking individuals recently released from prison and jail to the continuum of community-based HIV and OUD prevention and treatment services.

• $11.5M Grant Supports Study of Linkage to Community-Based Opioid Addiction and HIV Prevention and Treatment Services for Persons Released from Prison
• Yale ACTION Study Enrolling Patients

Affiliated Faculty: Jaimie Meyer, MD, MS
Funder: Substance Abuse and Mental Health Services Administration
Mechanism: Grants for the Benefit of Homeless Individuals
Period: 2019-2024

Comprehensive Housing and Addiction Management Network for Greater New Haven (CHANGE) aims to expand and enhance community infrastructure integrating housing, behavioral health, and addiction treatment services for highly vulnerable populations at risk for or living with HIV with a history of incarceration. By creating a “Patient-Centered Medical Home” enrolling up to fifty participants per year, CHANGE aims to improve reintegration post-incarceration and reduce recidivism. This will be achieved by 1) creating and enhancing sustainable partnerships with co-location of services for HIV, HCV, substance use and behavioral health treatment using the Community Healthcare Van (a mobile medical clinic); the city's largest HUD provider who will provide harm reduction services, HIV prevention, housing coordination and navigation services; and the Connecticut Department of Correction; 2) fully engaging and retaining individuals experiencing homelessness in quality primary care, mental health and substance use treatment; and 3) facilitating increased access to stable/permanent housing for people at-risk for or living with HIV who are transitioning from jail or prison.

• Experience Delivering an Integrated Service Model to People with Criminal Justice System Involvement and Housing Insecurity (BMC Public Health 2023)
• Meyer Lab
• Project CHANGE Website

Affiliated Faculty: Sandra Springer, MD; Kathleen T. Brady, MD, PhD; Frances Rudnick Levin, MD; Edward V. Nunes, MD
Funder: National Center for Advancing Translational Sciences
Mechanism: U01
Period: 2019-2024

Hospitalization presents a critical time to intervene among individuals with co-occurring opioid use disorder (OUD) and related infections such as HCV, HIV, bacteremia, and endocarditis. An injectable long-acting monthly formulation of buprenorphine (LAB) has a potential advantage for initiating MOUD treatment within hospital settings and bridging to treatment after discharge. Coordinated Medical Treatment of Opioid Use Disorder and Infectious Disease (Project COMMIT) is a multi-site RCT comparing two models of care for patients admitted with OUD and confirmed or suspected infection: addiction treatment standard of care versus LAB initiated while inpatient.

• InSTRIDE/Springer Lab

Affiliated Faculty: Thomas Kerr, PhD; Ryan McNeil, PhD
Funder: National Institute on Drug Abuse
Mechanism: R01
Period: 2017-2028

While fentanyl is a critical driver of North America’s overdose epidemic, rising fentanyl-stimulant polysubstance use and ongoing drug supply changes are worsening the situation and pose challenges to overdose prevention and addiction treatment approaches. Based in Vancouver, Canada, this study employs an innovative ethno-epidemiological approach to characterize how evolving drug use patterns and supply changes impact overdose vulnerability and intersect with social, structural, and environmental influences to impact the effectiveness of overdose prevention interventions. The study additionally explores social, structural, and environmental influences on treatment outcomes for existing and emerging opioid agonist treatment approaches among fentanyl-stimulant polysubstance- using and novel psychoactive substances exposed people who use drugs.

• $11.5M Grant Supports Study of Linkage to Community-Based Opioid Addiction and HIV Prevention and Treatment Services for Persons Released from Prison
• Yale ACTION Study Enrolling Patients

Affiliated Faculty: Kathryn Hawk, MD, MHS
Funder: National Institute on Alcohol Abuse and Alcoholism
Mechanism: R01
Period: 2023-2028

The emergency department (ED) encounter presents a unique opportunity to screen, enhance motivation, initiate medications, and refer to continuation care patients with alcohol use disorder (AUD) who both seek and do not seek alcohol use disorder (AUD) treatment. This open label RCT will evaluate two ED-based intervention models to increase AUD treatment provision and patient engagement: (1) Screening, Brief Intervention and Referral to Treatment (SBIRT), and (2) SBIRT with ED-initiated medications for AUD. Medications offered will include gabapentin and extended release or oral naltrexone.

• $11.5M Grant Supports Study of Linkage to Community-Based Opioid Addiction and HIV Prevention and Treatment Services for Persons Released from Prison
• Yale ACTION Study Enrolling Patients

Affiliated Faculty: Sandra A. Springer, MD
Funder: National Institute on Drug Abuse
Mechanism: DP1
Period: 2022-2027

Funded under the NIH Director’s Pioneer Award Program, this project aims to: 1) train people who live in communities affected by overdose to be community health workers (CHWs) and provide HIV testing and rapid diagnosis of OUD; 2) create mobile hubs that are pharmacies and clinics on wheels, to dispense pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), and medications for OUD (MOUD) anywhere; 3) develop mobile rapid response teams, comprised of CHWs and pharmacists with 24-hour support from online clinicians, that can bring medications to people with OUD where they ‘live’; and 4) collaborate with researchers to prioritize intervention where outbreaks of HIV are most likely to occur and provide a collaboration hub for others working in the fields of HIV and substance use disorders.

Affiliated Faculty: E. Jennifer Edelman, MD, MHS; Brian Kiluk, PhD; Melissa Weimer, DO, MCR
Funder: National Institute on Alcohol Abuse and Alcoholism
Mechanism: R01
Period: 2021-2026

Enhancing Hospital-initiated Alcohol TreatmeNT to InCrease Engagement (Project ENHANCE) is an RCT that will evaluate different treatment strategies to promote post-hospital discharge treatment engagement and alcohol reduction among individuals with untreated AUD. Patients eligible include those hospitalized for any reason, with alcohol use disorder, who were not receiving treatment prior to hospitalization, and who speak English or Spanish. Participants will be randomized to three treatments: brief counseling with referral to treatment, brief counseling with referral to treatment + facilitated initiation of medications for alcohol use disorder (MAUD), or brief counseling with referral to treatment + facilitated initiation of MAUD + ability to complete computerized sessions of cognitive behavioral therapy (CBT4CBT).

• Faculty in Addiction Medicine and Psychiatry to Expand Access to Treatments for Alcohol Use Disorder for Patients During and After Hospitalization
• Bringing CBT4CBT to the Hospital Setting to Reach a Diverse Sample of Patients with Alcohol Use Disorder: Project ENHANCE (Yale Addiction Medicine Grand Rounds)

Affiliated Faculty: Haidong Lu, PhD
Funder: National Institute on Drug Abuse
Mechanism: K99
Period: 2023-2025

Despite evidence supporting the effectiveness of medications for opioid use disorder (MOUD), access to these medications is still insufficient, with most patients remaining untreated. Enhancing knowledge about real-world effectiveness and guiding optimal use of MOUD in the clinical care of patients is of critical importance. This study, by leveraging electronic medical records from the Veterans Affairs, state-of-the-art data models, machine learning algorithms and causal inference methods, aims to provide a timely and unique opportunity to close these knowledge gaps and answer a set of timely questions centering around OUD care.

Affiliated Faculty: Emily Caterina Williams, MD; E. Jennifer Edelman, MD, MHS
Funder: National Institute on Alcohol Abuse and Alcoholism
Mechanism: R34
Period: 2022-2025

Informing and Promoting Shared Decision-making or HIV Prevention and Alcohol Reduction: Engaging Diverse Veterans to Refine and Pilot a Decision Aid (SHARE) employs sequential mixed methods guided by socioecological theory, the Consolidated Framework for Implementation Science, and the Discover/Design/Build/Test (DDBT) process to understand the impact of unhealthy alcohol use on the pre-exposure prophylaxis (PrEP) care continuum and then refine an existing decision aid to increase PrEP initiation in primary care at the point of alcohol-related care in the VA.

• $11.5M Grant Supports Study of Linkage to Community-Based Opioid Addiction and HIV Prevention and Treatment Services for Persons Released from Prison
• Yale ACTION Study Enrolling Patients

Affiliated Faculty: Jaimie Meyer, MD, MS
Funder: National Institute on Drug Abuse
Mechanism: R01
Period: 2023-2027

There is urgent need to reach women involved in criminal justice (WICJ) for lifesaving, evidence-based pre-exposure prophylaxis (PrEP) and medications for opioid use disorder (MOUD), using innovative healthcare delivery models that surmount existing social and structural barriers to engagement. This study aims to test innovative interventions to reduce stigma and improve the PrEP and opioid use disorder (OUD) care continua in women involved in the criminal legal system (WICJ). A validated decision aid and eHealth will remotely deliver integrated PrEP and MOUD to community based-WICJ with OUD in New Haven, Connecticut and Birmingham, Alabama.

Affiliated Faculty: Rajita Sinha, PhD; David Fiellin, MD
Funder: National Institute on Alcohol Abuse and Alcoholism
Mechanism: R01
Period: 2021-2026

Withdrawal symptoms of alcohol use disorder (AUD) are associated with greater treatment failure risk and higher rates of relapse and alcohol intake. Efficacy of current approved medications in AUD are modest, and none have been shown to be efficacious in those with alcohol withdrawal (AW). This study will evaluate the medication Prazosin in individuals with AUD + AW to improve alcohol outcomes, craving, and reduce associated anxiety and depression symptoms and improve physical health.

Affiliated Faculty: E. Jennifer Edelman, MD, MHS
Funder: National Institute on Drug Abuse
Mechanism: R01
Period: 2020-2026
NIH RePORTER Profile:https://reporter.nih.gov/search/4grImDyr3ES4EWB8bHBUDQ/project-details/10405633

Affiliated Faculty: Tami P. Sullivan, PhD; E. Jennifer Edelman, MD, MHS; Dawn M. Johnson, PhD
Funder: National Institute on Drug Abuse
Mechanism: R61
Period: 2023-2025
NIH RePORTER Profile:https://reporter.nih.gov/search/4grImDyr3ES4EWB8bHBUDQ/project-details/10812139

Affiliated Faculty: E. Jennifer Edelman, MD, MHS
Funder: National Cancer Institute
Mechanism: R01
Period: 2019-2025

Smoking is the leading threat to health of patients living with HIV (PLWH). A SMART Approach to Treating Tobacco Use Disorder in Persons Living with HIV (SMARTTT) is a two-arm, two-stage RCT aiming to (1) study the effectiveness of a dynamic treatment approach to reduce prevalence of smoking among PLWH and to identify the optimal approach; (2), study the effectiveness of various dynamic regimens on CD4 count, HIV viral suppression, and VACS index (validated measure of morbidity and mortality risk); and (3) identify barriers and facilitators to intervention delivery. Participants will be randomized to either combination nicotine replacement therapy (NRT) or combination NRT + contingency management (CM). At 12 weeks, responders in both arms will receive 12 more weeks of the same treatment. Non-responders will be re-randomized to 12 weeks of treatment, with varenicline or varenicline + CM. The intervention will be delivered by trained clinical pharmacists.

• A SMARTTT Approach to Treating Tobacco Use Disorder in Persons with HIV (SMARTTT): Rationale and Design for a Hybrid Type 1 Effectiveness-Implementation Study (Contemporary Clinical Trials 2021)
• Practices, Attitudes, and Confidence Related to Tobacco Treatment Interventions in HIV Clinics: A Multisite Cross-Sectional Survey (Translational Behavioral Medicine 2022)

Affiliated Faculty: Gail D’Onofrio, MD, MS; Kathryn Hawk, MD, MHS
Funder: National Institute on Drug Abuse
Mechanism: UG1
Period: 2023-2025

Narrowing the OUD treatment gap by expanding access to treatment beyond specialized drug treatment settings is a public health priority, and the Emergency Department (ED), offering access 24 hours, 7 days a week, 365 days a year, is a logical point of intervention. This multi-site randomized, double-blind, double-dummy clinical trial of emergency department (ED) patients with moderate to severe OUD will compare standard ED buprenorphine induction with high dose buprenorphine induction to evaluate engagement in continued OUD treatment and differences in outcomes of craving, tolerability, withdrawal symptoms, and use of illicit drugs.

Affiliated Faculty: Rebekah Heckmann, MD, MPA; Nasim S. Sabounchi, PhD
Funder: National Institute on Drug Abuse
Mechanism: R61
Period: 2022-2024

This HD2A Innovation Project aims to (1) implement a novel, scalable, evidence-based intervention that links people who have overdosed with access to medication for opioid use disorder, harm reduction services, and recovery supports, and (2) to collect high-quality data about the processes and outcomes associated with deployment of this platform that can be integrated with an existing system dynamics (SD) model to determine if, where, when, and what interventions should be implemented in the future.