Funded Projects

Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.

Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Sort descending Investigator(s) Location(s) Year Awarded
1R61DA059169-01
Leveraging Data to Action: Accelerating Emergency Department OUD Care by Improving Data Access and Infrastructure Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA YALE UNIVERSITY VENKATESH, ARJUN KRISHNA (contact); HAWK, KATHRYN; TAYLOR, RICHARD ANDREW New Haven, CO 2023
NOFO Title: HEAL Initiative: HEAL Data2Action – Innovation and Acceleration Projects, Phased Awards (R61/R33, Clinical Trial Optional)
NOFO Number: RFA-DA-23-057
Summary:

Emergency departments (EDs) are key settings for identifying and treating opioid use disorder (OUD), but EDs are underused for this purpose. This project aims to develop a data system that automates and integrates electronic health record and administrative data from EDs into the Clinical Emergency Department Registry, partnering with the American College of Emergency Physicians. The research will assess the digital readiness of ED systems before developing and deploying the enhanced ED OUD data infrastructure. This research aims to guide near-real time hospital quality improvement initiatives, toward development of a web-based, near-real time dashboard that can be used in EDs across the country.

1R21AT012430-01
Pain Management Strategies, Associated Psychological Variables, and Outcomes in Critical Limb Ischemia Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDCR YALE UNIVERSITY SMOLDEREN, KIM GERMAINE (contact); MENA-HURTADO, CARLOS New Haven, CT 2022
NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Management in Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011
Summary:

Critical limb ischemia is the most severe form of peripheral artery disease, is very painful, and can lead to amputation and even death. Most patients with this condition live with chronic pain, but comprehensive and effective treatment is lacking. This project will use existing data from three databases to study medical pain management approaches used over time by individuals with critical limb ischemia – toward creating an integrated, patient-centered, and multimodal pain management approach for this condition.

3UG1DA050072-02S2
Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN PATHS) study New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NIDA YALE UNIVERSITY Wang, Emily Ai-hua New Haven, CT 2020
NOFO Title: Notice of Special Interest (NOSI): NHLBI and NIDA Announce Availability of Administrative Supplements for HEAL Awardees to Address Sleep Impairments in OUD Treatment Response and Recovery Outcomes
NOFO Number: NOT-HL-20-746
Summary:

All forms of sleep deficiency can affect OUD treatment engagement and retention among people with OUD, particularly among people recently released from jail. Sleep deficiency may lead to a wide range of physical and psychological perturbations that may increase the likelihood of illicit opioid use, and disengagement in OUD treatment. This study will examine the association between sleep deficiency and OUD treatment retention in a sample of people receiving medications for OUD who were recently released from jail, to reduce morbidity and mortality from OUD among justice-involved individuals. The underlying rationale for this study is that sleep deficiency must be addressed in a holistic manner to support OUD treatment engagement. The specific aims are to 1) determine the prevalence of sleep deficiency and describe the sleep environment of a sample of people on MOUD recently released from jail; 2) estimate the association between sleep deficiency and OUD treatment retention; and 3) examine sleep environment as a potential mediator of sleep deficiency and OUD treatment retention in people recently released from jail. If successful, this study will provide data for the future development and testing of patient-centered interventions focusing on sleep deficiency among OUD treatment participants that enhance their retention in treatment

3UG1DA015831-21S3
National Institute on Drug Abuse Clinical Trial Network: New England Consortium Node Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIDA Yale University D’ONOFRIO, GAIL New Haven, CT 2022
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

The goal of this project is to discover potential targets for emergency department-based interventions that could enhance access to addiction treatment among Black and Latino individuals, who face significant disparities in access to ongoing addiction treatment. Through qualitative interviews with Black, Latino, and non-Latino White patients receiving emergency department-initiated buprenorphine, the research will identify patterns of barriers and facilitators for continuation of opioid use disorder treatment outside of the emergency department through a referral. The study will also evaluate differences in factors previously identified as predictors of worse treatment outcomes in these patient groups, including opioid overdose, polysubstance use, major depressive disorder, and stigma.

1U01HL150596-01
The Collaboration Linking Opioid Use Disorder and Sleep ("CLOUDS") Study New Strategies to Prevent and Treat Opioid Addiction Sleep Dysfunction as a Core Feature of Opioid Use Disorder and Recovery NHLBI Yale University YAGGI, HENRY KLAR (contact); BARRY, DECLAN T; REDEKER, NANCY S; SCHEINOST, DUSTIN New Haven, CT 2019
NOFO Title: HEAL Initiative: Sleep and Circadian-Dependent Mechanisms Contributing to Opiate Use Disorder (OUD) and Response to Medication Assisted Treatment (MAT) (U01 Clinical Trial Optional)
NOFO Number: RFA-HL-19-029
Summary:

Opioid use disorder (OUD) is a chronic and relapsing brain disease that affects over 2 million Americans. Despite effective evidence-based treatments in the form of behavioral interventions and FDA-approved medication for addiction treatment (MAT), relapse rates are high. The Collaboration Linking Opioid Use Disorder and Sleep Study will investigate patients on MAT to elucidate potential causal mechanisms between sleep deficiency and OUD. The aims of this study are to 1) test whether there are different neurocognitive connectivity patterns between patients with adequate vs. deficient sleep in brain systems involved in addiction and assess the extent to which these “neural fingerprints” predict ongoing opioid use; 2) evaluate the potential biologic, psychiatric, and pharmacologic mechanisms that explain the causal pathway between sleep deficiency and opioid use; and 3) test ecologic factors such as psychosocial, family, and neighborhood contextual factors associated with OUD and their contribution to sleep deficiency among patients in MAT.

1U01DK123817-01
Video-Telecare Collaborative Pain Management to Improve Function and Reduce Opioid Risk in Patients with End Stage Renal Disease Receiving Hemodialysis Clinical Research in Pain Management Integrated Approach to Pain and Opioid Use in Hemodialysis Patients NIDDK YALE UNIVERSITY BECKER, WILLIAM C (contact); CROWLEY, SUSAN T; ESSERMAN, DENISE ; HEAPY, ALICIA New Haven, CT 2019
NOFO Title: HEAL Initiative: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Clinical Centers (U01 Clinical Trial Required)
NOFO Number: RFA-DK-18-030
Summary:

Research on optimal long-term opioid therapy (LTOT) tapering strategies has lagged behind clinical needs. Patients with end-stage renal disease (ESRD) receiving hemodialysis (HD) may be especially vulnerable. This study will adapt the Collaborative Opioid Reassessment Program (CORP) and Cooperative Pain Education and Self-Management (COPES) interventions for patients receiving HD and LTOT and test their effectiveness in a pragmatic sequential multiple assignment randomized trial (SMART) design. Initial randomization will be to compare CORP-supported taper with (CORP-B) and without (CORP) buprenorphine rotation on the six-month composite outcome of LTOT dose reduction and pain response. This design will allow determination of which of the eight adaptive treatment strategies leads to the greatest reduction in six-month opioid dose and pain interference.

1UG3DA050251-01
A digital intervention to prevent the initiation of opioid misuse in adolescents in school-based health centers New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Yale University Fiellin, Lynn E. New Haven, CT 2019
NOFO Title: HEAL Initiative: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16–30) (UG3/UH3 Clinical Trial Required
NOFO Number: RFA-DA-19-035
Summary:

Most opioid misuse begins during adolescence and young adulthood. Adolescence is the best time for prevention interventions in settings like school-based health centers (HCs), yet few programs focus on preventing initiation of opioid misuse. This study harnesses the power of video game interventions and incorporates components of effective substance use prevention programs to develop an evidence-informed intervention to prevent the initiation of opioid misuse in adolescents. In partnership with the national School-Based Health Alliance (SBHA), researchers will develop and test a new video game intervention, PlaySmart. It will build on our previous video game intervention that has demonstrated efficacy in improving attitudes and knowledge related to risk behaviors. The study will evaluate the game in a randomized controlled trial (RCT) in 10 school-based HCs and examine strategies for implementing PlaySmart in school-based HCs nationally. This research has considerable potential for wide implementation, reach, and impact on high-risk adolescents through school-based HCs.

1RM1DA055310-01
HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers Clinical Research in Pain Management Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL) NIDA YALE UNIVERSITY BECKER, WILLIAM C (contact); BARRY, DECLAN T; FIELLIN, DAVID New Haven, CT 2021
NOFO Title: HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required)
NOFO Number: RFA-DA-21-030
Summary:

Health care services for patients with both chronic pain and opioid use disorder are fragmented in the United States. To develop effective and feasible interventions for chronic pain and opioid misuse/disorder that can be implemented in both general medical and addiction treatment settings, this research examines two different care-delivery strategies. The first project will compare the effectiveness of a pharmacist-led, collaborative care approach for patients prescribed long-term opioids who have chronic pain and  opioid misuse/disorder compared to a pharmacist program with a cognitive behavior therapy-based pain self-management program. The second project will examine the effectiveness of a multimodal, interdisciplinary chronic pain management program that includes cognitive behavioral therapy, exercise, and stress management. With input from stakeholders and individuals with lived experience, this research has the potential to generate novel, reproducible, and scalable findings that addresses fragmented care delivery for co-occurring chronic pain and opioid misuse/disorder.

1UG1DA050072-01
Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN PATHS) study Translation of Research to Practice for the Treatment of Opioid Addiction Justice Community Opioid Innovation Network (JCOIN) NIDA YALE UNIVERSITY WANG, EMILY AI-HUA New Haven, CT 2019
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-025
Summary:

Correctional settings have the potential to serve as key players in linking individuals with opioid use disorder (OUD) to treatment and health services upon release. Many individuals with OUD are being treated with medications, but these efforts will be ineffective if they fail to connect people to OUD treatment upon release. The Transitions Clinic Network (TCN) program provides enhanced primary care and OUD treatment for people recently released from incarceration. In TCN, formerly incarcerated community health workers are embedded within primary care teams and address social determinants of OUD, provide social support, help patients build trust in the health system, and advocate in interactions with the criminal justice system. This study will assess the effectiveness of the TCN: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN PATHS) intervention versus referral to standard primary care on opioid treatment cascade outcomes and whether housing, food access, criminal justice contact, and social support mediate this association.

3U24AT009769-02S1
PAIN MANAGEMENT COLLABORATORY COORDINATING CENTER (PMC3) New Strategies to Prevent and Treat Opioid Addiction NCCIH Yale University KERNS, ROBERT D; BRANDT, CYNTHIA A. NEW HAVEN, CT 2018
NOFO Title: NIH-DoD-VA Pain Management Collaboratory - Coordinating Center (U24)
NOFO Number: RFA-AT-17-002
Summary:

The Pain Management Collaboratory Coordinating Center (PMC3) will 1) provide national leadership and technical expertise in all aspects of research supporting the design and execution of high-impact demonstration projects that conduct cost-effective, large-scale, pragmatic clinical trials on non- pharmacological approaches for pain management and other comorbid conditions in veteran or military health care systems and 2) make data, tools, best practices, and resources from these and other projects available to facilitate research partnerships in VA and DoD health systems. The aims are to: 1) develop, adapt, and adopt technical policy guidelines and best practices for the effective design and conduct of pragmatic trials; 2) work collaboratively with and provide operational, technical, design, and other support to demonstration project teams to develop, initiate, and implement a research protocol; and 3) disseminate NIH–DoD–VA Pain Management Collaboratory–endorsed policies and best practices and lessons learned within military and veteran health care systems.

1U24DA058673-01
Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long-Term Opioid Therapy - Yale Resource Center (MIRHIQL-YRC) Clinical Research in Pain Management Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL) NIDA YALE UNIVERSITY BECKER, WILLIAM C (contact); BLACK, ANNE C; DEBAR LYNN L; EDMOND, SARA; ESSERMAN, DENISE New Haven, CT 2023
NOFO Title: HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL): Resource Center (U24- Clinical Trial Optional)
NOFO Number: RFA-DA-23-042
Summary:

Decreasing opioid dosing faster than advised by clinical recommendations often leaves chronic pain unaddressed and may increase the risk of overdose and suicide compared to continuing long-term opioid treatment. The MIRHIQL Resource Center will provide infrastructure support for the network as well as create a risk-benefit decision tool to help providers determine when opioids should be continued as prescribed, tapered, or tapered/discontinued. The center will first develop and validate a clinical definition for individuals who take long-term opioids, then study long-term outcomes in participants who receive treatment in primary care settings. This research will partner with many groups including individuals with lived experience, community health care providers who treat such individuals, research scientists, bioethicists, and professional societies

1R01DA047094-01A1
Guanfacine Target Engagement and Validation to Improve Substance Use Outcomes in Women Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA YALE UNIVERSITY Sinha, Rajita New Haven, CT 2019
NOFO Title: NIH Research Project Grant (Parent R01 Clinical Trial Required)
NOFO Number: PA-18-345
Summary:

There are currently no FDA-approved treatments for cocaine use disorder (CUD) or co-occurring substance use disorder. High relapse rates pose a major obstacle to treatment, and this is due in part to the way that high drug cravings reduce individuals’ cognitive flexibility in situations where they are stressed or exposed to drug-related cues. These effects appear to be stronger in women with CUD than in men. Building on preliminary data that a drug called Guanfacine reverses these effects in women, but not in men, this 3-year pilot clinical study will test whether Guanfacine will reduce cocaine use and increase abstinence and will use laboratory challenges to determine whether it reduces cravings and enhances cognitive flexibility in stressful or drug-cue-related situations.

3UH3DA050251-03S1
The Role of Family Functioning and Race/Ethnicity on the Efficacy of an Opioid Misuse Prevention Videogame Intervention for Adolescents New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA YALE UNIVERSITY FIELLIN, LYNN ELIZABETH New Haven, CT 2021
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

Most opioid misuse begins during adolescence and young adulthood. Adolescence is the best time for prevention interventions in settings like school-based health centers (HCs), yet few programs focus on preventing initiation of opioid misuse. This study harnesses the power of video game interventions and incorporates components of effective substance use prevention programs to develop an evidence-informed intervention to prevent the initiation of opioid misuse in adolescents. In partnership with the national School-Based Health Alliance (SBHA), researchers will develop and test a new video game intervention, PlaySmart. It will build on our previous video game intervention that has demonstrated efficacy in improving attitudes and knowledge related to risk behaviors. The study will evaluate the game in a randomized controlled trial in 10 school-based HCs and examine strategies for implementing PlaySmart in school-based HCs nationally. This research has considerable potential for wide implementation, reach, and impact on high-risk adolescents through school-based HCs.

3UG1 DA013035
Emergency Department-INitiated bupreNOrphine and VAlidaTIOn Network Trial (ED-INNOVATION) Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA YALE UNIVERSITY; NEW YORK UNIVERSITY Gail D'Onofrio/Roger Weiss; John Rotrosen/Edward Nunes New Haven, CT 2021
NOFO Number:
Summary:

Emergency department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing BUP is superior to referral alone in engaging patients with untreated opioid use disorder (OUD) in treatment at 30 days and is cost-effective. However, logistical barriers exist in translating research into practice. New BUP formulations such as the extended-release injectable BUP (CAM2038, XR-BUP) hold promise in addressing many of the barriers more effectively than sublingual buprenorphine (SL-BUP) by treating the patients’ symptoms for up to seven days. This study will recruit, train and provide resources to 30 ED sites throughout the U.S. using implementation facilitation strategies to address stigma and provide ED-initiated BUP for patients presenting with OUD who are not receiving medications for OUD. Once implementation is adequately achieved, the sites will conduct a randomized controlled trial (RCT) to compare the effectiveness of SL-BUP versus XR-BUP on ED patients’ engagement in formal addiction treatment seven days after their ED visit. In addition, in an ancillary component of the study, the use of XR-BUP will be assessed in ED patients with Clinical Opioid Withdrawal Scale (COWS) scores of 4-7.

2R44MD015912-03
Clinical Optimization of Ultrasonic Drug Delivery Technologies for Underserved Minority U.S. Veterans in Chronic Pain Cross-Cutting Research Small Business Programs NIMHD ZETROZ SYSTEMS, LLC LEWIS, GEORGE KENNETH Trumbull, CT 2023
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 - Clinical Trial Required)
NOFO Number: RFA-NS-20-010
Summary:

Osteoarthritis is one of the most common joint diseases affecting Americans. Osteoarthritis is particularly high among veterans with a service-related disability. This project will develop and refine a wireless ultrasound device that increases the penetration of over-the-counter pain medications into the body, which is expected to reduce pain. The research will conduct safety and clinical testing toward commercializing this technology. 

1R43DA049684-01
Non-intrusive detection of temporary neurologic impairment by opioids Cross-Cutting Research Small Business Programs NIDA ZXEREX CORPORATION BESSERMAN, RICHARD Scottsdale, AZ 2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
NOFO Number: PA-18-573
Summary:

With the exception of the Breathalyzer for alcohol, there is currently no available technology that can immediately identify neurologic impairment related to the use of licit or illicit drugs. The presently available methods for detecting opioids—which rely upon analysis of urine, blood, saliva, or hair—are expensive, time-consuming to implement, and can take days to deliver actionable information to meet the “fitness-for-duty” concerns of employers as well as the needs for immediate detection of drug use in the drug rehabilitation and public safety fields. This project intends to develop a non-invasive means of identifying temporary neurological impairment from prescription opioids using analysis of involuntary eye movements. The resultant biometric signature of opioid impairment will be incorporated into Zverex’s existing product library of oculomotor biosignatures, such as marijuana impairment and fatigue.