Funded Projects

NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

Most people with opioid use disorder are either not in treatment or receive inconsistent treatment. Peer support is proven to be effective at engaging patients who are unwilling or unable to seek traditional treatment, but commonly available group support models are often separate from other clinical care or are otherwise hard for patients to access. This research will test a novel, machine learning enabled, digital peer support program added to an anonymous text-based social network that can provide 24/7 support for patients at all stages of recovery. The project will examine the ability of this digital service to engage and retain patients with opioid use disorder and will also develop novel techniques to automatically analyze patient messages for clinical and social determinants of health-related needs.

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:

Currently available treatments for opioid use disorder (OUD) are insufficient for many patients. Novel compounds that can promote alterations in brain connections (i.e., neural plasticity) possess enormous potential for improving substance use disorder (SUD) treatments. Psychedelic compounds induce neural plasticity and can elicit long-lasting, beneficial impacts on a wide variety of SUDs. However, these compounds have significant side effects, including hallucinations and cardiotoxicity. Researchers have developed a novel, synthetic derivative of the psychedelic ibogaine, called tabernanthalog, that does not have these side effects. This compound has demonstrated both short- and long-term therapeutic effects in a preclinical model of OUD. This research study will determine the molecular and neural mechanisms through which tabernanthalog affects opioid seeking. It will also evaluate whether the effects are specific to opioids and do not alter response to natural rewards and will examine the efficacy of tabernanthalog in a preclinical model of comorbid opioid and alcohol use disorder.

NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R43/R44 – Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-011
Summary:

Chronic pelvic pain is a debilitating condition that negatively affects the social and sexual quality of life for up to 20% of American women. Pelvic floor muscle (PFM) pain is caused by many factors, as well as by incorrect posture and excessive sensitization of the peripheral nervous system. This project will introduce a prototype of the Chronic Pelvic Pain (CPP) HomeTrainer that monitors, quantitatively and in real time, both PFM activation capacity and muscle interactions between the PFM and hip/trunk muscles and adapts the PFM training to the user’s needs in their own home. The proposed CPP HomeTrainer offers biofeedback to aid myofascial physical therapy and movement pattern training by tailoring the protocol to specifically correct interactions between the PFM and problematic hip/trunk muscles.

NOFO Title: HEAL Initiative: Advancing Health Equity in Pain Management (R61/R33 Clinical Trial Required)
NOFO Number: NS22-002
Summary:

Both pain experience and treatment response are determined by a variety of factors, including race and ethnicity. Inequities in access to healthcare and pain treatment affect patients from minority populations, such as Hispanic/Latino populations of all age groups. This study will develop and test an online intervention—Web-based Tailored Intervention for Preparation of Parents and Children for Outpatient Surgery (L-WebTIPS)—tailored for Latino families of children having outpatient surgeries. The intervention aims to lower child and family anxiety before surgery as well as to reduce post-surgical pain by enhancing parent self-efficacy and behavioral pain coping strategies. After an exploratory phase to assess usability and acceptability of the intervention, the study will evaluate the impact of L-WebTIPS on child pre-surgery anxiety and post-surgery pain as well assess other child and parent outcomes.

NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

Lumbar spinal surgery, an increasingly common surgery in adults with severe chronic back pain, is associated with acute post-surgical pain, costly postoperative opioid-related adverse effects, long hospital stays, high-risk for chronic post-surgical back pain, and persistent opioid use and dependence. Each individual responds differently to opioids based on their unique genetic and clinical factors, and the current trial-and-error approach to opioid use and prescribing promotes excessive opioid use, costly adverse outcomes, and poor surgical pain management. To address this issue, this research project will develop a preoperative diagnostic test that will use genetic and clinical information to proactively assess each person’s risk for opioid-related adverse events and chronic post-operative pain. The results will help clinicians provide personalized pain management to maximize pain relief while minimizing opioid-related safety risks, including opioid dependence.

NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed)
NOFO Number: NS21-029
Summary:

There is a continued need to discover and validate new targets for potential therapeutic strategies for effective and safe treatment of pain. This project focuses on the protein metadherin, also known as astrocyte elevated gene-1 protein (AEG-1), as a possible new target for pain treatment. Preliminary studies have shown that mice genetically engineered to lack metadherin had significantly lower inflammation and chronic pain-related behaviors. This project aims to further validate AEG-1 as a pain target and test whether reducing levels in white blood cells called macrophages might work as a therapeutic strategy to reduce chronic inflammatory and/or neuropathic pain using an innovative nanoparticle approach to target specific cells.

NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development [Small Molecules and Biologics] (R61 Clinical Trial Not Allowed)
NOFO Number: NS21-029
Summary:

Chronic pain from tissue injury often stems from long-term changes in spinal cord circuits that change nerve sensation. Reversing these changes may provide better pain therapeutics. Previous work in animal models showed that activating G protein-coupled receptor 37 (GPR37) dampens nerve signal intensity after long-term stimulation and alleviates pain behavioral responses. This project aims to validate GPR37 in the spinal cord as a useful target for new treatments for neuropathic pain. The work will facilitate screening and identification of new molecules that activate GPR37, which can then be tested for efficacy and safety in further research in animal models of pain.

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-22-066
Summary:

Pain is a common problem for people with end-stage renal disease that receive hemodialysis. Opioid use rates in this population are almost three times that of the general U.S. population over 65, putting them at significant risk for addiction. This research is testing treatments to manage chronic pain in this patient population. This project will develop educational materials to overcome barriers to telehealth toward enhancing research participation by American Indian/Alaska Native communities.

NOFO Title: Research Networks for the Study of Recovery Support Services for Persons Treated with Medications for Opioid Use Disorder (R24 Clinical Trial Optional)
NOFO Number: RFA-DA-20-014
Summary:

Individuals with opioid use disorder tend to be more in need of additional services; feel more isolated and marginalized; have less available resources such as education, training, employment, and housing opportunities (collectively known as “recovery capital”); and report lower quality of life than those with other substance use disorders. Recovery Community Centers (RCCs) are designed specifically to help grow recovery capital and enhance remission and quality of life. Preliminary evidence suggests RCCs are particularly valuable for people with opioid use disorder, but little is known about their clinical and public health benefits and cost-effectiveness. This project will organize activities on a national level to enhance research on RCCs. It builds on existing professional and academic resources, including an established recovery dissemination platform (i.e., the Recovery Research Institute).

NOFO Title: Research Networks for the Study of Recovery Support Services for Persons Treated with Medications for Opioid Use Disorder (R24 Clinical Trial Optional)
NOFO Number: RFA-DA-20-014
Summary:

Central Appalachia has been devastated by opioid use disorder and overdose deaths for decades. Treatment access is improving across that region, yet few individuals successfully remain on treatment with medications for opioid use disorder (MOUD). Peer recovery support services can be highly effective in improving treatment outcomes and recovery, but there is limited evidence of how they can be implemented and used most effectively, particularly for individuals receiving MOUD. This project will create the Studies To Advance Recovery Supports (STARS) Network that aims to expand the infrastructure necessary to implement and evaluate peer recovery support services for these individuals. It will build research capacities at universities and health partners, enroll MOUD clinics and peer recovery support professionals, and promote data harmonization across network partners.

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
Summary:

Negative Affect (NA) and stress are key features of Opioid Use Disorder (OUD) and often lead to drug use and relapse. The Autonomic Nervous System (ANS) dominates physiological responses to emotions and stress, yet its function and how it unfolds over time and in real-world settings remains understudied in the context of OUD. With new wearable technologies, ANS function can be measured through heart rate variability (HRV) and can be recorded continuously via wearable sensors, providing a non-invasive method to examine physiological mechanisms underlying stress and NA in real-world settings and in real-time. The present research will serve as a pilot study to assess 1. The role of autonomic function (indexed by HRV) as a marker of NA and stress in people with OUD 2. Participants’ adherence to wearing sensor devices and response rates to daily questionnaires. To achieve these objectives, we will monitor participants for 14 days and quantify self-reports measures of stress, overall daytime HRV patterns, and the magnitude, frequency, and duration of reduced HRV instances. Our findings can help advance technologies to address the opioid epidemic, and our understanding of physiological markers as objective measures and predictors of NA and stress in OUD.