Funded Projects

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

Including all population subgroups in clinical research is important to ensure that research results apply to the entire population and can be implemented effectively. However, many communities are underrepresented in health research due to individual, cultural, or structural reasons. This project aims to develop a Health Beliefs Toolkit that will be a readily accessible resource for researchers, providers, and community groups to help them engage diverse and minority populations in clinical research, particularly regarding substance use disorders. The project will examine, adapt, and test existing materials and resources targeting individual and structural barriers to research engagement. The toolkit will also assess individuals’ knowledge of health as well as health-related personal values and beliefs to enhance health and research “literacy.” The toolkit will be targeted to primary care providers, community health workers, peer counselors, agency representatives, and patient and non-patient groups to enhance practice-based research in underserved communities.

NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative template of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive and well curated research dataset to the scientific community at large. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The University of New Mexico Health Science Center study site is in a largely rural/mixed state with one of the highest rates of overdose in the nation. This site will enroll diverse mother-infant pairs and partners or caregivers, including Hispanic/Latinx and American Indian individuals.

NOFO Title: HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1 Clinical Trial Required)
NOFO Number: RFA-HD-21-031
Summary:

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. 

New Mexico is an epicenter of the opioid epidemic with high rates of maternal opioid use disorder and NOWS. This site has expertise in multi-center clinical trials for newborns, a history of high rates of study recruitment and follow-up, and a diverse population that includes Latinx and Native American women. The hospital currently cares for infants with NOWS in a variety of settings, including rooming in, a nursery, and a neonatal intensive care unit.

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:

There are a dearth of integrated treatments that simultaneously address the fundamental causes of chronic pain and opioid misuse/opioid use disorder and that focus on well-being among individuals with chronic pain and opioid misuse/disorder. This research will study how to improve the lives of patients with chronic pain and opioid misuse/disorder via tailored interventions that explicitly target increasing quality of life and engagement in valued activities, the cultural centering of interventions to meet the needs of diverse patient populations and reducing stigma of chronic pain and opioid misuse/disorder. Specific research projects will i) test the effectiveness, mechanisms, and implementation of an integrated psychosocial treatment for chronic pain and opioid use disorder among individuals receiving buprenorphine from outpatient treatment clinics, and ii) will use community-based participatory research methods to develop a culturally centered strategy for screening and brief intervention of chronic pain and opioid use disorder among American Indian/Alaska Native patients in primary care settings. This research will shed light on a difficult problem and improve health and wellbeing with a focus on diverse and underserved populations.

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:

The opioid antagonist naltrexone (NTX) is a proven treatment for opioid use disorder (OUD); however, lack of adherence is a serious limitation that has prevented NTX from reaching its maximum therapeutic potential. To address this limitation, BioCorRx is developing BICX102, a subcutaneous solid depot pellet of NTX, a single implantation of which can provide continual blockade of opioid receptors for up to 3 months. This can prevent patients from being adversely affected by almost any opioid relapse event, while improving efficacy and adherence to behavioral programs that support long-term management and recovery. This proposal comprises the steps required to achieve FDA approval. Successful development of BICX102 would result in a safe and effective 3-month subcutaneous depot pellet/implant containing NTX (1,000 mg) that would be far less reliant on patient compliance.

NOFO Title: HEAL Initiative: Understanding Polysubstance Use and Improving Service Delivery to Address Polysubstance Use (R01 Clinical Trial Optional)
NOFO Number: DA22-047
Summary:

Little is known about what motivates people to use multiple drugs. Understanding these factors is important for tailoring treatment services. Behavioral economic theory, which determines how much value individuals assign to drugs and potential negative consequences, provides a framework to understand the choices people make. This project will identify patterns, motivating factors, and long-term trajectories of opioid-involved polysubstance use behaviors and treatment. This research will use a range of methods to analyze substance use episodes as well as examine motives and preferences associated with polysubstance use behaviors and how they change over time. The findings will be combined into a toolkit to inform timing, type, and tailoring of interventions and policies to guide implementation of effective clinical strategies and policies for managing polysubstance use in healthcare systems.

NOFO Title: NIH Research Project Grant (Parent R01)
NOFO Number: PA-16-160
Summary:

Morbidity and mortality related to prescription opioids are accelerating in the United States. Identifying the factors that lead to new opioid dependence among opioid naïve patients is a critical opportunity to reduce prescription opioid dependence and unintended diversion. In the United States, the majority of individuals who become opioid dependent receive their first opioid prescription following surgical procedures, yet there are no clinical guidelines to inform appropriate postoperative opioid use. We will examine the patient factors that are associated with postoperative pain and opioid consumption among a cohort of patients undergoing common elective abdominal procedures. We will identify the provider characteristics in postoperative opioid prescribing practices, and design and implement a provider-directed intervention to optimize postoperative opioid prescribing. Findings will inform patients and providers regarding the risk of opioid dependence following surgery, and will establish a patient-centered data infrastructure that yields continuous feedback to providers regarding appropriate opioid prescribing practices.

NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002

NOFO Title: HEAL Initiative Limited Competition: Behavioral Research to Improve MAT: Ancillary Studies to Enhance Behavioral or Social Interventions to Improve Adherence to Medication Assisted Treatment for Opioid Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-AT-19-007
Summary:

Chronic pain may be linked to poorer outcomes in those using medication-assisted treatments (MAT) to treat opioid use disorders (OUD). Psychosocial interventions for pain have been effective in patients with chronic pain and substance use disorders, but these interventions have not been thoroughly examined in the OUD population receiving MAT. The study team previously refined and adapted a psychosocial pain management intervention (PPMI) to be delivered by telephone for patients with OUD receiving MAT. The current study will understand the potential applicability of this intervention to other high-risk groups, such as veterans, study the longer-term impact of PPMI, and gather data to inform the implementation of PPMI in MAT patients. This work will provide a robust test of the PPMI intervention to help enhance MAT outcomes in a larger and more representative group of participants while also paving the way for future implementation of interventions to improve MAT retention.

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:

The national public health opioid crisis has disproportionately burdened rural white populations and American Indian populations. To address this crisis, the Cherokee Nation and Emory University public health scientists will carry out an opioid prevention trial to be conducted in at-risk rural communities in the Cherokee Nation (in northeast Oklahoma) with populations of white and American Indian adolescents and young adults. The study will expand and integrate two established intervention approaches, consisting of community organizing and universal school-based brief intervention and referral to further enhance their effects in preventing and reducing opioid misuse. These interventions, called CMCA and CONNECT, were originally designed to target adolescent alcohol use, but showed significant beneficial effects on use of other drugs, including prescription drug misuse. The expanded, integrated interventions will be tested in a community-randomized trial with the goal of new systems for sustained implementation within existing structures of the Cherokee Nation.

NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. This study will be conducted at Emory University School of Medicine in Atlanta, Georgia, allowing access to a diverse population with a high representation of Black/African American women.

NOFO Title:
NOFO Number: PAR18-494

NOFO Title: Notice of Special Interest(NOSI): HEAL Initiative: Social Network Analyses to Reduce American Indian and Alaska Native Opioid Use Disorder and Related Risks for Suicide and Mental Health Disorders
NOFO Number: NOT-DA-20-033
Summary:

American Indian and Alaska Native (AI/AN) youth and young adults experience disproportionately high rates of suicide, mental health disorders, traumatic life events, and substance use disorder. More effective, culturally informed interventions are needed that are tailored to the specific needs of this population. This supplement will examine how a person?s social network contributes to their behavioral health (suicide risk, mental health, substance use) status and how this network can be leveraged to improve the uptake of prevention interventions. The long-term goal is to disseminate and translate the lessons learned into practical policy, organizational changes, and preventive innovations that optimize patient-centered health outcomes and ultimately reduce or eliminate the dramatic and tragic suicide-related health disparities among urban AI/AN YYAs.