Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1UG3DA050322-01
Preclinical and clinical evaluation of the NMDA modulator NYX-783 for OUD Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA Yale University DiLeone, Ralph New Haven, CT 2019
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002
Summary:

This study will conduct preclinical and clinical assessments of the NMDA modulator NYX-783 for treatment of opioid drug-seeking and relapse to opioid use disorder (OUD). NYX-783, a novel small molecule being developed by Aptinyx, has shown evidence of safety/tolerability in Phase 1 studies and is currently in Phase 2 trials for post-traumatic stress disorder. This project will test the safety, tolerability, and pharmacokinetics (PK) of NYX-718 in morphine-maintained patients in residential settings and then conduct a combined inpatient (safety/tolerability/PK) / outpatient (preliminary efficacy) study testing NYX-783’s effects on opioid use and relapse, stress/cue reactivity, craving, and quality of life in OUD subjects maintained on standard extended release naltrexone over a 10-week period. Successful completion of these studies will set the stage for larger scale Phase 2/3 studies of efficacy in OUD that will ultimately be required for FDA approval of NYX-783 for the treatment of drug-seeking and relapse in OUD.
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.
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
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.
1R33DA059884-01
ADAPT: Adaptive Decision Support for Addiction Treatment Translation of Research to Practice for the Treatment of Opioid Addiction Optimizing the Quality, Reach, and Impact of Addiction Services NIDA YALE UNIVERSITY MELNICK, EDWARD ROBERT New Haven, CT 2023
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-054
Summary:

Computerized clinical decision support tools offer a promising strategy to standardize and scale evidence-based practices to keep pace with the dynamic nature of the opioid crisis and overcome barriers to substance use disorder treatment. To change practice, such tools must be useful, usable, able to be integrated into routine care delivery, and supported by a multicomponent implementation strategy. This project will refine and evaluate the uptake, usability, and equity of a nationally disseminated multicomponent clinical decision support intervention to increase initiation of medication treatment for opioid use disorder in the emergency department.
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.
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.