Funded Projects

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

Although methadone is an effective treatment for opioid use disorder, many individuals drop out of treatment, putting them at risk of relapse and overdose. One of the factors associated with poor retention in methadone treatment is concurrent cocaine use. There is currently no effective medical treatment for cocaine use disorder. However, contingency management, in which individuals receive tangible rewards for desired behaviors such as abstinence, has been shown to be effective for cocaine use. This project will test the value of a digital therapy app, DynamiCare Health Contingency Management, in methadone treatment programs to promote treatment for polysubstance use.

NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01)
NOFO Number: PAR-19-327
Summary:

Currently no medications are approved by the U.S. Food and Drug Administration to treat cocaine use disorder, which compromises cognitive function associated with achieving goals such as working memory, the ability to update information, and mental flexibility. This project will test whether  stimulating dopamine activity in the brain with the drug rotigotine (approved to treat Parkinson’s disease) is effective for treating cocaine use disorder. Past research has also shown that rotigotine can improve nerve cell and cognitive function in Alzheimer’s disease. This project will conduct a clinical trial to test whether treatment with rotigotine combined with cognitive behavioral therapy can reduce cocaine use in people with cocaine use disorder.

NOFO Title: HEAL Initiative: Planning Grants for Efficacy or Effectiveness Trials of Recovery Support Services for Individuals Treated with Medications for Opioid Use Disorder (R34 Clinical Trial Optional)
NOFO Number: RFA-DA-22-034
Summary:

Many people intending to take medications for opioid use disorder, including buprenorphine, as part of their recovery pathway do not stay in treatment long enough to reduce risk for overdose. These individuals also often continue to use one or more other drugs during treatment, which may further raise their overdose risk. This project will develop and conduct a preliminary test of an innovative integrated intervention that combines buprenorphine treatment with recovery coaching and online cognitive behavioral therapy. This research will assess whether the approach reduces drug use during buprenorphine treatment and helps people stay in treatment longer.

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

Compared to people with stable housing, individuals experiencing homelessness are more likely to use both fentanyl and stimulants and experience drug-related harms. This project will examine fentanyl-stimulant polysubstance use patterns and how they evolve over time in response to changes to housing status. It will also assess use of overdose prevention and substance use disorder treatment interventions in homeless individuals who use both fentanyl and stimulants, including how polysubstance use patterns shape their risk of overdose over time. This research will also interact with community stakeholders toward translating the findings into future research, policy, and program recommendations.

NOFO Title: HEAL Initiative: HEAL Data2Action Innovation Projects (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-22-051
Summary:

First responders prevent many overdose deaths by providing life-saving resuscitation and giving naloxone to reverse an opioid overdose. This project will use a modeling approach to assess the impact of Good Samaritan Laws that protect people from certain criminal penalties if they call 911 to save an overdose victim by giving naloxone on overdose mortality. This research will develop and test a novel, scalable, telehealth platform that can be used at the time of an opioid overdose to link patients with access to medication for opioid use disorder, harm reduction services, and recovery support. The research will be informed by patient-outcome data.

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

Polysubstance use, especially use of both opioids and stimulants, is compounding the already devastating effects of the opioid crisis in underserved rural areas. This project builds on a previously established treatment model for opioid use disorder that uses telehealth and mobile treatment units, which seeks to engage people in activities they enjoy, to help them avoid negative behaviors such as drug use. This research will evaluate the effectiveness of a behavioral treatment approach delivered by peer recovery support specialists in rural areas and using mobile treatment units. The project will measure the intervention’s effect on treatment retention and polysubstance use – as well as evaluate the intervention’s feasibility, acceptability, adoption, and economic value.

NOFO Title: Emergency Awards: HEAL Initiative-Early-Stage Discovery of New Pain and Opioid Use Disorder Targets Within the Understudied Druggable Proteome (R21 Clinical Trial Not Allowed)
NOFO Number: TR22-011
Summary:

Chronic pain severely reduces the quality of life and ability to work for millions of Americans. Because misuse of opioids for chronic pain treatment contributes to opioid addiction and opioid overdose, there is an urgent need to study novel non-opioid mechanisms, targets, and treatment strategies for chronic pain. Many ion channels control the flow of electrical signals in peripheral sensory neurons and are thus key targets for understanding and treating chronic pain. This project will conduct detailed studies to identify major ion channel-related molecular activities, targets, and treatment strategies for chronic pain. In particular, this research will explore the role of a specific ion channel (lysosomal mechanosensitive ion channel, orTmem63A) in neuropathic pain resulting from nerve injury.

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

Opioids can be effective analgesics but can also be fatal due to opioid-induced respiratory depression after overdose. This project will use cutting-edge molecular, physiological, behavioral, and imaging techniques to better understand and distinguish opioid-induced respiratory depression and opioid-mediated analgesia. Nerve cell-specific, single-cell transcriptomic analysis will be used to identify functional markers expressed in nerve cells that play a specific role in opioid-induced respiratory depression, but not opioid analgesia. This research study will help to identify novel therapeutic targets that could selectively rescue opioid-induced respiratory depression while maintaining the beneficial pain-relieving effects of opioids. 

NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: PAR-20-092
Summary:

Fentanyl and its analogs are synthetic opioids that are 100 to 10,000 times more potent than morphine. Overdose from these opioids is extremely dangerous due to their ultra-potency and longer half-life than naloxone, the front-line treatment for fentanyl overdose. This research study will develop novel mu opioid receptor antagonists that bind to the same receptor as the opioid drugs and specifically counteract fentanyl and its analogs, thereby reversing the drugs’ acute toxicity more effectively and with fewer side effects than current treatments. The researchers will characterize novel fentanyl derivatives, identify promising compounds, and pursue preclinical development of these compounds as novel reversal agents against the acute toxicity of fentanyl. The goal is to file an Investigational New Drug application with the U.S. Food and Drug Administration.

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:

The goal of this project is to discover potential targets for emergency department-based interventions that could enhance access to addiction treatment among Black and Latino individuals, who face significant disparities in access to ongoing addiction treatment. Through qualitative interviews with Black, Latino, and non-Latino White patients receiving emergency department-initiated buprenorphine, the research will identify patterns of barriers and facilitators for continuation of opioid use disorder treatment outside of the emergency department through a referral. The study will also evaluate differences in factors previously identified as predictors of worse treatment outcomes in these patient groups, including opioid overdose, polysubstance use, major depressive disorder, and stigma.

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-19-020
Summary:

Relapse is common in people with opioid use disorder, and recovery attempts often fail within 6 months. This research project will test a novel virtual reality intervention to improve recovery outcomes for people recovering from opioid use disorder. By increasing future orientation and delay-of-reward behavior with a precision medicine personalized experience, the intervention is designed to enhance advantageous decision-making and increase positive future outcomes. The results of this study will provide critical data for creating a commercially viable software product for facilitating relapse prevention and improving opioid use disorder recovery outcomes.