Funded Projects

NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-036
Summary:

Structural and functional neuroimaging measures are prone to errors induced by subject motion. Many comorbid features of opioid exposure are likely to increase children’s in-scanner motion. In total, this raises substantial concern that existing neuroimaging methods are not sufficiently motion-robust to be used in studies of children ages 3–5. Researchers will address these concerns with a feasibility study, comparing the existing methods developed for the Adolescent Brain Cognitive Development (ABCD) study with novel methods we will develop and optimize for young children. They will evaluate research methods in a sample of 100 children and test whether novel technologies improve the quality of the raw imaging data and reduce motion biases in the derived measures. Researchers will determine predictors of successful imaging to inform sampling strategies in future studies. The primary outcomes will be novel, validated structural and functional neuroimaging imaging methods for young children and feasibility data to inform the design of future studies addressing developmental questions, particularly those related to opioid exposure.

NOFO Title: HEAL Initiative: Preventing Opioid Misuse and Co-Occurring Conditions by Intervening on Social Determinants (R01 - Clinical Trials Optional)
NOFO Number: RFA-DA-23-051
Summary:

Non-punishment, support-based preventive interventions in schools are needed to reduce misuse of opioids and other substances among youth. This project will test an intervention to improve school climate by introducing a learning approach that encourages behavior that is supportive and respectful in middle schools. ISLA reduces the use of exclusionary and discipline practices, such as suspensions and expulsions, that can be racially discriminating. The research aims to improve inclusive teaching practices, student engagement, student-teacher relationships, and school climate, while reducing student misuse of opioids and other substances.

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: The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-008
Summary:

New Mexico (NM) is an epicenter of the opioid crisis in the United States. Many challenging social determinants, including poverty and unemployment, contribute to high rates of opioid use disorder (OUD) in NM. The aims of the NM node are to (1) develop and maintain a highly efficient platform to conduct clinical trials that will inform evidence-based prevention and treatment of OUD; (2) collaborate on and lead research that addresses and improves outcomes across the OUD Cascade of Care (CoC); and (3) promote uptake of best practices in OUD prevention and care in NM and nationwide through effective dissemination of evidence-based innovations. NM node research will ensure the development of robust and generalizable methods for prevention, identification, and treatment of OUD, including evaluation and modification of the CoC to expand the local and national knowledge base.

NOFO Title: HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)
NOFO Number: RFA-NS-21-010
Summary:

Cholecystokinin B receptor (CCKBR) is a molecule found in the brain that helps regulate anxiety and depression but also influences the development of tolerance to opioids. CCKBR levels are also increased in models of nerve injury-induced (neuropathic) pain. Therefore, targeting CCKBR may offer a new approach to treating neuropathic pain and the associated anxiety and depression. Researchers have developed mouse antibodies that can inactivate CCKBR. However, to be usable in humans without causing an immune response, these antibodies need to be modified to include more human sequences. This project will use a fragment of the CCKBR antibody, modify it with the addition of human antibody sequences, and then select the clones that bind most strongly and specifically to human CCKBR. These will then be tested in cell and animal models of neuropathic pain to identify the most promising candidates for further evaluation in humans.

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: 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; PA-21-071
Summary:

Few integrated treatments are available that simultaneously address the fundamental causes of chronic pain and opioid misuse/opioid use disorder and focus on well-being among individuals with chronic pain and opioid misuse/opioid use disorder. This research will inform development of patient-centered interventions that increase quality of life and engagement in valued activities, are culturally appropriate for use by diverse patient populations, and reduce stigma related to chronic pain and opioid misuse/opioid use disorder. The results of this project will be used to inform future research focused on developing mobile health treatments for individuals with chronic pain and opioid use disorder, and for developing culturally appropriate treatments for chronic pain and opioid use disorder in Hispanic/Latino individuals.

NOFO Title: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp Clinical Trial Not Allowed)
NOFO Number: PA21-071
Summary:

There are currently few effective therapies available for chronic nerve injury-induced pain, associated anxiety, and depression. This project aims to extend previous research aiming to uncover the mechanism of action of artificially modified immune molecules (humanized cholecystokinin-2 receptor [CCKBR] single-chain variable fragments [scFv]) on human neurons and how it reverses chronic pain and anxiety-like behaviors in mouse models. This potential treatment approach offers important advantages over existing therapies, including extreme specificity, higher affinity, brain/nerve penetrance, safety, and reduced self-immunogenicity.

NOFO Title: HEAL Initiative: Harm Reduction Policies, Practices, and Modes of Delivery for Persons with Substance Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-22-046
Summary:

While some people who use drugs do not carry or use naloxone, others respond to multiple overdoses over short periods of time. This project aims to identify characteristics and experiences of these individuals, known as “overdose responders,” toward better understanding barriers to naloxone use. The research will also test interventions to support the well-being of responders and to increase the number of community members ready and willing to give naloxone to reverse overdose. 

NOFO Title: Development of Vaccines for the Treatment of Opioid Use Disorder
NOFO Number: BAA-DAIT-75N93019R00009
Summary:

High rates of relapse and overdose deaths pose significant challenges to the treatment of Opioid Use Disorder (OUD). Anti-opioid immunotherapies (i.e., vaccines and monoclonal antibodies) have great potential to reduce long-term opioid use and overdose, with minimal risk of side effects, when used in conjunction with pharmacological treatments and/or behavioral therapies. The ability of an anti-opioid vaccine to induce antibodies that render an opioid less effective, or less rewarding, and protect from accidental overdose could provide an important therapeutic option for patients undergoing treatment for OUD. The goal of this collaborative study is to design, develop, and evaluate vaccines for use in the treatment of opioid use disorder

NOFO Title: HEAL Initiative: Therapeutics Development for Opioid Use Disorder in Patients with Co-occurring Mental Disorders (UG3/UH3 - Clinical Trial Optional)
NOFO Number: RFA-DA-23-049
Summary:

People who have anxiety and/or depression are particularly susceptible to misusing opioids to avoid negative emotional states. This project aims to develop and test a fully autonomous (no-human operator) cognitive behavioral therapy-based digital therapeutic for people with co-occurring opioid use disorder and anxiety or depression. The goal is to specifically target compulsive opioid use motivated by the relief of unpleasant emotions. The researchers will modify an existing digital therapeutic and test its efficacy in this patient population.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Sickle cell disease (SCD) is an inherited hematologic disorder accompanied by severe pain, inflammation, and vascular injury. We propose that nociceptor activation by ongoing hypoxia/reperfusion (H/R) injury leads to the release of neuropeptides by sensory nerves in the skin, stimulating vascular insult and mast cell activation in SCD. In turn, mast cell tryptase activates protease-activated receptor 2 on sensory nerve endings, resulting in exaggerated neuroinflammation, vascular injury, and central sensitization. Our general hypothesis is that neurogenic inflammation contributes to pain in SCD and that cannabinoids provide analgesia by disrupting neurogenic inflammation and nociceptor sensitization. We also hypothesize that EEG and functional MRI can be used to optimize analgesic treatments in SCD. We propose to use transgenic sickle mice, and individual cells involved in evoking pain, to perform this translational study. A proof of principle study in humans will examine the effect of cannabis on pain in sickle patients.

NOFO Title: HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-031
Summary:

Novel treatments for opioid use disorder are urgently needed. Previous research has shown that angiotensin-converting enzyme (ACE) can control levels and activity of natural, “endogenous,” opioids in a way that might reduce the rewarding effects of opioids like fentanyl. ACE inhibitors have been used to treat hypertension for decades, with no evidence of addiction or dependence. This research will evaluate ACE effects on endogenous opioids toward generating new, domain-specific ACE inhibitors with optimized properties for treating opioid use disorder. The research will also test the behavioral impact of these compounds in preclinical models of opioid use disorder.