Funded Projects

This proposal aims to test the impact of an empirically derived implementation strategy—under real-world conditions and across multiple child service systems—on successful adoption and sustainment of two evidence-based programs that address adolescent substance abuse: Treatment Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and Multidimensional Family Therapy (MDFT). The overarching goal of this proposal is to evaluate whether the integration of implementation fidelity (fidelity to the implementation process) with intervention fidelity (fidelity to the clinical intervention) can increase the probability that a new organizational site not only successfully adopts a program but develops the infrastructure to ensure it can sustain. This study will (a) evaluate the effect of stages of implementation completion coaching strategy (SIC-CS) on outcomes of program adoption and sustainment, (b) extend the SIC to include measurement of sustainment, and (c) examine cost and resource patterns most likely to yield sustainable programs.

Effective medication-based treatment could prevent overdose deaths and help individuals recover from opioid use disorder, but only a fraction of those in need access treatment or receive a medication approved by the U.S. Food and Drug Administration. One way to improve people’s choice to seek and stay in treatment is to improve training for addiction treatment counselors beyond current methods that rely on brief online or in-person workshops. The goal of this research project is to develop and evaluate the technical feasibility and commercial viability of a scalable digital program to train behavioral addiction professionals in Community Reinforcement and Family Training (CRAFT), an evidence-based approach to increase treatment entry, using ongoing counselor training with feedback and coaching.

Novel treatments for opioid use disorder are critically needed as the addiction and overdose crises continue. Neuromodulation is a promising supplemental treatment to standard care. The overarching project seeks to evaluate low-intensity focused ultrasound that targets the nucleus accumbens, a primary component of the brain’s reward neurocircuitry. This supplement will expand the number of participants in part of the study and will increase the project’s overall impact consistent with the original objectives and aims of the parent grant.

With nearly 116 million people suffering from chronic pain in the United States, there is a need for new analgesics without the risks posed by opioids. Antagonists acting at TRPV1 receptor have long been recognized as one of the most promising novel classes of non-opioid analgesics. Initial tests in humans have confirmed that this class of drugs produces analgesia and is safe and well-tolerated, but side effects include hyperthermia and partial loss of heat sensitivity, leading to most research being halted. This project will conduct a set of preclinical proof-of-concept studies in rats to support the claims that, at doses that have minimal, clinically acceptable, or negligible impact on cardiovascular function, a2 adrenoceptor agonists can diminish thermoregulatory effects of TRPV1 receptor antagonists.

The goal of this proposal is to launch an innovative, multi-modal neuroimaging program that will investigate the longitudinal trajectory of the neurodevelopment of irritability across the preschool period. Differentiating clinically salient irritability from developmentally normative temperamental variation has proven to be a difficult task. This is made even more challenging during the preschool period, when irritability has hit its normative peak and measuring neurodevelopment is impeded by methodological constraints. This research will (1) identify specific biomarkers underlying preschool vulnerability for psychopathology by examining neural maturation in executive function as a predictor for clinical outcome; and (2) examine how the parenting environment moderates this vulnerability, with the overarching objective of identifying aberrant irritable trajectories as the foundation for future brain-based behavioral intervention. Primary analyses will (1) probe underlying executive function as a predictor of clinical outcome; and (2) examine parent-child neural synchrony as a predictor of executive function maturation.

The Great Lakes Node (GLN) of the NIDA-supported Drug Abuse Clinical Trials Network (CTN) will serve as a vital Midwestern hub for the CTN and expand on the success of the CTN approach. The GLN aims include (1) identify substance misuse research and intervention protocols focused on systems-based practice; (2) establish a digital and computation health core for studies in mHealth, eHealth, artificial intelligence, natural language processing, and telehealth interventions; (3) bring substantial expertise with youth/adolescent health and seniors/aging to examine prevention strategies to mitigate these life-course pathways; (4) support work on opioid misuse that focuses on health disparities, including socioeconomic, geographic, sexual orientation, and gender identity; (5) leverage experience in professional education and practice-based learning to test the impact of professional education on opioid and substance use treatment; and (6) expand the pipeline of early investigators interested in substance misuse research.

There is a critical need to expand research infrastructure to develop, test, and implement new clinical interventions and evidence-based opioid use disorder (OUD) treatment into diverse clinical settings. The University of Utah’s Greater Intermountain Node (GIN) will expand the existing NIDA Clinical Trial Network’s (CTN) infrastructure by developing and testing innovative OUD interventions, expanding the settings for CTN research, and bringing new research acumen to the CTN. GIN brings expertise in three spheres of OUD research: (1) non-addiction health care settings, (2) large health systems of care, and (3) implementation science. GIN’s specific aims include (1) enhance CTN’s ability to conduct research in primary care and non-addiction care settings; (2) enhance CTN’s ability to conduct research within integrated systems of care with “big data” resources; and (3) enhance CTN’s implementation of science research to integrate and disseminate evidence-based addiction care into diverse non-addiction and health system targets.

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.

The incidence of Neonatal Opioid Withdrawal Syndrome (NOWS) in the United States has increased more than fivefold since 2004 to almost 7 per 1,000 hospital births. It is unknown how these effects are modulated by associated maternal, neonatal, and environmental factors and how the environment, maternal health, and parenting styles modify trajectories of brain connectivity and neurodevelopment. This study leverages the established infrastructure and longstanding collaborations of four clinical sites and the data coordinating center of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network to address current critical knowledge gaps in childhood brain structure and connectivity and on medical, developmental, and behavioral trajectories in early childhood. The study will analyze a well-characterized observational cohort using clinical and neuroimaging measures to improve understanding of the structural and functional sequelae resulting from prenatal opioid exposure and NOWS and their interactions with the maternal-infant dyad.

Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS. 

This project is part of a multi-center, randomized controlled clinical trial that directly compares NOWS treatments—morphine, methadone, and buprenorphine—and takes into account other types of non-drug therapies, such as behavioral interventions. The goal is to generate results that can inform clinical practice guidelines and give newborns with NOWS the best start possible. 

Arkansas is a rural state with the second highest opioid prescription rate in the nation and is in the top 3 states nationwide for opioid prescriptions to pregnant mothers. This site has extensive experience in opioid research and conducting multi-center clinical trials. It also provides care to a diverse population.

Neonatal Opioid Withdrawal Syndrome (NOWS) is a condition that occurs when newborns are exposed to opioids during pregnancy. Symptoms often include tremors, excessive crying, sleep deprivation, and swallowing difficulties. Cases are rising, with a newborn affected by NOWS approximately every 15 minutes. Currently, healthcare providers in the United States lack standard, evidence-based treatments for NOWS. 

This project is part of a multi-center, randomized controlled clinical trial that directly compares NOWS treatments—morphine, methadone, and buprenorphine—and takes into account other types of non-drug therapies, such as behavioral interventions. The goal is to generate results that can inform clinical practice guidelines and give newborns with NOWS the best start possible. 

Ohio and Kentucky have high rates of opioid-related overdose deaths in the nation. This site is a large regional perinatal center, providing clinical services for approximately 25,000 newborns each year. It also actively participates in other HEAL Initiative studies.

Although there are effective prevention and treatment programs and services to address opioid misuse, opioid use disorder (OUD), and overdose, gaps remain between those needing and those receiving prevention and treatment, in part because of a need to better understand how to make these programs and services most effective at a local level. The National Institutes of Health (NIH) and the Substance Abuse and Mental Health Services Administration (SAMHSA) launched the HEALing Communities Study to generate evidence about how tools for preventing and treating opioid misuse and OUD are most effective at the local level. This multisite implementation research study will test the impact of an integrated set of evidence-based practices across health care, behavioral health, justice, and other community-based settings. The goal of the study is to reduce opioid-related overdose deaths by 40 percent over three years. The University of Kentucky is partnering with academic institutions in three other states to study the impact of these efforts in 67 highly affected communities. The study will also look at the effectiveness of coordinated systems of care designed to increase the number of individuals receiving medication to treat OUD, increase the distribution of naloxone, and reduce high-risk opioid prescribing.

Although there are effective prevention and treatment programs and services to address opioid misuse, opioid use disorder (OUD), and overdose, gaps remain between those needing and those receiving prevention and treatment, in part because of a need to better understand how to make these programs and services most effective at a local level. The National Institutes of Health (NIH) and the Substance Abuse and Mental Health Services Administration (SAMHSA) launched the HEALing Communities Study to generate evidence about how tools for preventing and treating opioid misuse and OUD are most effective at the local level. This multisite implementation research study will test the impact of an integrated set of evidence-based practices across health care, behavioral health, justice, and other community-based settings. The goal of the study is to reduce opioid-related overdose deaths by 40 percent over three years. Columbia University is partnering with academic institutions in three other states to study the impact of these efforts in 67 highly affected communities. The study will also look at the effectiveness of coordinated systems of care designed to increase the number of individuals receiving medication to treat OUD, increase the distribution of naloxone, and reduce high-risk opioid prescribing.