National Advisory Council on Drug Abuse (NACDA) Approved Concepts

A concept describes the purpose, scope, and objectives of a potential funding opportunity. Concepts are posted to give interested researchers additional time to plan for application submissions. Approved concepts are usually developed into Requests For Applications (RFAs), Program Announcements that include set-aside funds (PASs), or Program Announcements with special receipt, referral and/or review considerations (PARs). The NACDA conducts most, but not all, NIDA concept clearances. Concepts may also be cleared through other public venues.

Please send questions regarding specific concepts to the program contact listed in the description. Please also note that to avoid any conflicting information, once a concept has been finalized as a published RFA (or similar funding announcement), it is deleted from this early notification, concept clearance list.

Concept Index:


Patient Engagement Resource Centers

Posted September 2022  

Background

Only 1 in 10 people who need SUD treatment ever receive it. When asked, patients and families note that available treatment options are unacceptable, undesirable, inconvenient, and inadequate to address their needs. For example, in responses to the 2020 NSDUH, individuals who met diagnostic criteria for SUD but did not receive treatment indicated the following most common reasons:  uninsured/could not afford; could not find a program that offered what they wanted; feared negative opinions of others; felt treatment wasn’t needed/could handle the problem on their own; did not have time. This NSDUH response pattern has been largely the same for two decades. Compounding these concerns are widely held perspectives (reinforced by popular media) that treatment comes in only one form: highly structured, largely institutionalized programs that are lengthy, expensive, and stigmatized. This means that efforts to implement new treatments into existing systems of care are unlikely to reduce the treatment gap. Likewise, recent efforts to integrate addiction services into general medical settings either have not permeated public awareness, or are not the solution patients are seeking.

Goal

The goal of this concept is to support the development of Patient Engagement Resource Centers that can effectively engage patients (including prospective patients, families of individuals with SUD, and persons in recovery) in meaningful dialogue to inform the design and delivery of high-quality treatment services that are responsive to their needs and preferences. Projects would take a user-centered design approach to identify and articulate patient perspectives on treatment and their desired structures and outcomes, and inform the development of new models of care that better align with these preferences. Projects would also be encouraged to test dissemination strategies to better educate the public about the full array of evidence-based treatment options available.

Lori Ducharme, Ph.D., Division of Epidemiology, Services, and Prevention Research


Leveraging Inpatient Medical or Surgical Hospitalizations to Improve Outcomes for People Who Use Drugs

Posted September 2022 

Background

In the United States, a relatively small number of high-need patients account for a disproportionately high level of healthcare utilization, including hospital admissions and costs. Having a substance use disorder (SUD) increases the risk of an individual falling into this high-risk, high-need population. Individuals with SUD can experience worse outcomes for their medical or surgical hospitalizations because of stigma or because their SUD may complicate the treatment in other ways (for example, poor venous access in people who inject drugs). At the same time, individuals being treated in medical or surgical wards may not receive evidence-based treatment for SUD or be linked to outpatient SUD treatment on discharge.

There are existing models for initiation of SUD treatment during general inpatient hospital stays, some of which involve linkage to care post-discharge (e.g., addiction consult services, consultation liaison psychiatry referrals, care coordinators, patient navigators, bridge clinics, etc.). Some of these have been studied formally for short time periods and/or at limited scale, with far more focus on the emergency department initiation and linkage than the inpatient components. There is literature to support the idea the hospital may be an appropriate place to screen for and assess SUDs, that SUDs may complicate or extend the hospital stay, and that initiation of treatment during hospitalization with linkage to continued outpatient care can be beneficial in reducing hospital readmissions.

Goal

The goals of this initiative are:

  • to identify the best inpatient screening, treatment initiation, and linkage models for different hospital and service systems, such as rural vs urban, large vs small hospitals, and safety net systems, including cost impacts and economic evaluations
  • to identify strategies to support the successful implementation, sustainability, and scalability of effective and cost-effective inpatient initiation and linkage interventions
  • to identify strategies to assure that patients can continue appropriate substance use disorder care after hospital discharge
  • to evaluate the impact of inpatient-to-outpatient linkage of substance use disorder care on hospital readmissions and long-term patient outcomes including morbidity, mortality, and substance use outcomes

Marcy Fitz-Randolph, DO, MPH, Division of Epidemiology, Services, and Prevention Research


Rapid Translation of Epidemiological Findings Into Interventions to Prevent Substance Use and Addiction

Posted September 2022 

Background

Epidemiologic studies, including the analysis of existing data, aim to identify risk and protective factors for substance use and addiction, furthering our understanding of the etiology of substance use and its consequences for individuals and communities. A natural next step for epidemiologic research is intervention development research, to determine if those identified risk and protective factors are modifiable. Longitudinal studies of risk groups could also facilitate a study of heterogeneity which, in turn, could lead to personalized approaches to intervention.  However, this translation can take many years or never occur if descriptive studies are done without a specific target prevention audience, stakeholder, intervention, or process (e.g., Blanco, Lopez & Goldstein, 2020). Often institutional incentives prioritize research that stays within a field and there are institutional challenges to the formation of the multidisciplinary teams and research approaches that enable true crosstalk between epidemiology and prevention. Successful and rapid translation requires active partnership between epidemiology and prevention science, creating cross-disciplinary teams with diverse scientific perspectives.

Goal

The goal of this initiative is to support bi-phasic research that would expedite translation from epidemiology into prevention science. This translation focused concept will support innovative epidemiologic research to provide the foundation for a targeted prevention intervention. Specifically, multi-disciplinary teams would be encouraged to use primary data collection or leverage existing data sets to identify populations experiencing risk for substance use or misuse and/or modifiable targets for prevention interventions.  A second phase of the research would then use the findings from the epidemiologic investigation to either a) adapt or target an existing intervention to increase effect size or reach a new population or b) develop a novel intervention to address a new prevention target. Additionally, this concept will aim to capitalize on bidirectional translational science, supporting studies of the ‘back translation’ from prevention to epidemiological inquiry.

Alexa Romberg, Ph.D., and Keva Collier Kidemu, M.D, M.P.H, M.B.A., Division of Epidemiology, Services, and Prevention Research 


Rural Community-Centered Prevention and Harm Reduction Research—Responding to the Fourth Wave Opioid/Psychostimulant Epidemic and its HIV/HCV Consequences in the U.S.

Posted September 2022 

Background

Data suggest that we have entered a fourth wave of the opioid epidemic, notable for the combination of opioids and stimulant misuse and continuing increases in overdose. There also is increasing recognition of mental illness as a co-occurring condition.  It is estimated that only 12.7% of individuals with co-occurring mental illness and SUD receive services for both.  Individuals who live in rural areas face unique challenges to accessing services such as greater stigma, fewer providers, more reliance on publicly funded services, and longer travel distance to service settings, with gaps in Wi-Fi coverage limiting the reach of telehealth.  The COVID pandemic has made it more difficult to receive treatment, prevention, and harm reduction services to reduce drug misuse and contain the spread of infectious diseases such as HIV and HCV.

Goal

In 2017, NIDA launched the Rural Opioid Initiative to inform community responses to promote comprehensive, integrated approaches to prevent HIV and hepatitis C virus (HCV) infection among people who inject drugs in rural US communities.   The proposed concept would build upon the success of this effort, testing interventions to improve substance use and infectious disease outcomes across the continuum of prevention and care, including health promotion, primary prevention, harm reduction, treatment, and recovery.  This concept capitalizes on prevention approaches that are not specific to a single substance. Projects supported through this effort would propose intervention strategies to address more than one point on a continuum of prevention and care, including strategies to intervene early to interrupt the progression from substance use to SUD.  Studies should test relevant theories of behavior change in the context of offering scalable interventions based on evidence-based practices to respond to the fourth wave of the opioid epidemic.  As with the first rural opioid initiative projects, this initiative will test strategies tailored to local communities, with attention to changing drug use trends, available health services, financing capabilities, and stigma in the context of receiving services.  Ultimately, the goal is to provide communities with packages of interventions that could be executed in response to community needs – be that a need to prevent new cases of OUD, stimulant use disorder, HIV, and HCV while providing high-quality harm reduction, treatment, and recovery services to individuals in rural areas who have opioid or other substance use disorders.

Aria Crump, Sc.D., Division of Epidemiology, Services, and Prevention Research,


Using Cost‐Effective Technology to Develop Accessible and Affordable Products to Reduce (or Even Eliminate) Disparities in Substance Use Disorder (SUD) Diagnosis and Treatment

Posted September 2022  

Background

More than 100,000 deaths from overdose were reported from April 2020 to April 2021 alone, continuing the upward trend from the previous decade. To stem the tide of deaths, there is a need to expand the current model of diagnosis and treatment.

Research suggests that 75% of the patients who receive treatment eventually recover and lead healthy normal life. Furthermore, it has been shown that long-term treatment significantly lowers rates of illicit drug use. Therefore, increasing the availability of treatment may help saving lives.

Currently, there are often significant barriers to receiving any treatment, which include geographical location, cost and stigma. In states with low population density, access to treatment can be hindered by the distance to treatment facility, especially in rural areas. Furthermore, the full cost of treatment (intervention services, patient care, tests, etc.) currently vary between $15k and $27k. Often, these numbers are deterrent to lead many individuals to not enter treatment as they think they cannot afford it. Stigma can also prevent a person from seeking help.

Therefore, there is a significant unmet need for better access to SUD diagnosis and treatment, together with the ability to quickly initiate and sustain it at the point of need. Many patients experience significant hurdles in finding appropriate treatment options, commuting for required appointments, getting the prescriptions filled, receiving sufficiently long treatment and staying in remission after recovery. The problem is that there is a paucity of field-deployed, cost-effective point-of-care technologies (POCT) that encompass the patient journey through SUD. Of specific interest would be technologies for use in low resource settings (e.g., community treatment centers in poor neighborhoods, jails, rural communities) that enable initiation and/or continuity of treatments. The availability of such technologies will allow to bring the treatment to the patient, and not the patient to the treatment.

Goal

This concept seeks to bring POC technologies SUD treatment in lower resource settings to commercialization. Specifically, the applications may address:

  • Cost-effective POCT devices and approaches for diagnostics and treatment,
  • POCT methods and devices that support therapeutic regiment while reducing the stigma from the treatment (technology that anonymizes the patient to everybody but the physician, eases access to prescription with exposing it to community, etc.)
  • Cost-effective POCT devices for physiological monitoring during the treatment and recovery.
  • POCT technologies that increase access to treatment in poor and rural communities, correctional facilities, as well as in tribal areas.
  • POCT devices for non-pharmacological treatment and/or sustained abstinence (TMS, US, VR, etc.)

Yordan Kostov, Ph.D., Office of Translational Initiatives and Program Innovations (OTIPI)  


Marijuana Farm and Analytics to Support the Availability of Consistent, High-Quality Material to Facilitate Cannabis Research

Posted September 2022  

Background

A contract to grow marijuana has existed since 1968, when it was under NIMH, and was established to ensure a pesticide/herbicide-free source of marijuana for scientific research.

Since the initial award, the contract site has been University of Mississippi, with Mahmoud ElSohly, becoming the project director in 1981.

The contract was the first federally legal source of cannabis for research and until recently, was the only DEA-approved manufacturer of bulk cannabis, although now there are five DEA-approved sites that can grow marijuana.

NIDA needs a continuous, standardized supply of cannabis and placebo material for research and clinical trials.  The existing contract also provides all the analytic services to determine content and purity of product produced by the Farm and from DEA and state agencies. 

Goals 

The purpose of this contract is to support the availability of consistent, high-quality material to facilitate cannabis research

  • Grow, harvest, and process cannabis plant material to produce standardized marijuana with different potencies for research.
  • Manufacture and distribute marijuana cigarettes to researchers.
  • Develop very low potency materials (almost no THC) to be used as a placebo for clinical trials.
  • Isolate and characterize different cannabis components for pharmacological studies.
  • Screen cultivars of different chemical profiles (THC, CBD and THC/CBD) for research purposes.
  • Prepare bulk quantities of specific cannabinoids (for example, THC, CBD, CBN, CBC, and CBG) as research-grade materials.
  • Ship cannabis materials to researchers throughout the U.S.
  • Follow good manufacturing practices of the US Food and Drug Administration (FDA) in preparing materials for clinical trials.
  • Initiate, maintain, and support Drug Master Files (DMF)s with the FDA.
  • Analyze confiscated cannabis products from DEA/State Agencies.

Jane B. Acri, Ph.D., Division of Therapeutics and Medical Consequences


Exploratory Clinical Neuroscience Research on Substance Use Disorders

Posted September 2022  

Background

According to The National Survey on Drug Use and Health, in 2017, approximately 19.7 million people aged 12 or older had a substance use disorder (SUD) in the past year, including 7.5 million people who had an illicit drug use disorder. Increased negative health consequences from opioid use are a leading public health problem in the US. In addition to this ongoing opioid crisis, the substance use landscape has witnessed several other recent developments: an increase in the use of psychostimulants, the growing popularity of e-cigarette consumption, and the legalization of medical and recreational marijuana. Together, these factors have renewed attention to the need for novel approaches to understanding the mechanisms underlying SUD, including clinical research studies that illuminate the neurobiological underpinnings of the disease.

Goal

This concept continues NIDA’s interest in exploratory clinical neuroscience research on SUD to support clinical research applications that are in early and conceptual stages of project development and focus on understanding the neurobiological mechanisms underlying SUD, including fundamental brain function relevant to substance use. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Topics that would be appropriate for this concept include, but are not limited to:

  • Investigation of individual differences in neural circuitry underpinning SUD-related behavior and outcomes, including studies to understand the neurobiology underlying important risk factors for drug use and addiction
  • Testing of environmental, behavioral, or pharmacological manipulations that leverage potential treatment or prevention targets in all phases of drug taking behavior seen in the progression to development of SUDs, and identification of mechanisms of action
  • Development of computational models of network-level neural function and connectivity in the context of SUD
  • Investigation of neurobiological mechanisms related to transdiagnostic factors shared by SUD and other psychiatric disorders
  • Studies characterizing the interactions of substance use and HIV/AIDS

Vani Pariyadath, Ph.D.,  Division of Neuroscience and Behavior


Responsible Analyses of Complex, Large-Scale Data

Posted September 2022  

Background

With the widescale availability of large, open datasets (e.g., ABCD), human neuroscience has shifted towards a population-level approach to understanding brain structure and function and its association with behavior. Because of the large sample sizes and heterogeneity of these datasets, there is a high likelihood that analyses will produce statistically significant effects with small effect sizes that may not be clinically or biologically meaningful. Responsible use of such data therefore requires knowledge of analytical and statistical considerations specific to large datasets, such as population inference, sampling variability, and covariate inclusion. However, with the increasing availability of open datasets, many investigators are attempting analyses of large-scale, complex data for the first time and with varied levels of sophistication. Further, recently, the spotlight has fallen on the social determinants of health or “the societal, environmental, and economic conditions that impact and affect health outcomes” (World Health Organization Commission final report, 2008). Along with this unprecedented motivation and opportunity to study socioenvironmental influences comes a responsibility to incorporate the broader social context and the suitability of the dataset when designing research questions (Simmons et al., 2021; Laird, 2021). Taken together, there is an urgent need for research training that contextualizes study design and statistical analyses with respect to social determinants of health.

References:

  • WHO Commission on Social Determinants of Health, and World Health Organization. Closing the gap in a generation: health equity through action on the social determinants of health: Commission on Social Determinants of Health final report. World Health Organization, 2008.
  • Laird, Angela R. "Large, open datasets for human connectomics research: Considerations for reproducible and responsible data use." NeuroImage244 (2021): 118579.
  • Simmons, Cortney, et al. "Responsible use of open-access developmental data: the adolescent brain cognitive development (ABCD) study." Psychological science6 (2021): 866-870.

Goal

This concept proposes to advance methodological rigor in NIDA-relevant research by supporting training on the responsible analyses of complex, large-scale datasets involving brain, behavioral, genomic, and socioenvironmental data through:

  • Hands on courses and activities aimed at data analysis
  • Curriculum development for the broader research community

Vani Pariyadath, Ph.D., Division of Neuroscience and Behavior

Elizabeth Hoffman, Ph.D., Division of Extramural Research


Translating Socioenvironmental Influences on Neurocognitive Development and Addiction Risk (TransSINDA)

Posted September 2022 

Background

There is a substantial body of evidence regarding the impacts of the social environment - defined as one’s social network and its interaction with the physical environment - on brain and cognitive development.  As recent examples, prospective longitudinal studies such as HBCD and ABCD are integrating approaches informed by public health, developmental cognitive psychology, and neuroscience to examine the impact of socioenvironmental factors on brain development in the context of risk for SUD and its comorbidities.  

Currently, there exists a gap in how socioenvironmental factors influencing SUD risk are incorporated into animal model research relevant to SUD. Multiple factors contribute to this gap, including a relative paucity of longitudinal non-human studies and computational models of early social environment in neurocognitive development and SUD risk phenotypes in adolescence and/or adulthood. A consortium of animal model research programs utilizing common research design elements and contributing data to a collaboratively designed and coordinated data archive would be foundational to supporting data-driven, translational computational approaches that will allow animal model findings to inform and be informed by human studies such as ABCD and HBCD.

Goal

The goal of this concept is to create pathways to support a coordinated animal research program aimed at addressing the overarching question: What are the mechanisms mediating the impact of the social environment during early life on neurobehavioral development and the emergence of SUD risk-relevant behaviors?  This program would support longitudinal research in animal models to discover and test causal mechanisms. Supported projects would be required to incorporate

  • Research questions informed by the human developmental research examining the impact of social environmental factors on neurocognitive development and SUD risk.
  • Animal model paradigms (e.g., from developmental psychobiology) that have been validated as mechanistic models of specific psychosocial or socioenvironmental factors impacting neurobehavioral development.
  • Research designs that incorporate 1) developmentally appropriate. precisely timed socioenvironmental and neurobiological manipulations, 2) longitudinal readouts of neurocognitive function and 3) adolescent/adult neurobehavioral phenotypes relevant to SUD risk.

Programs supported under this concept will leverage established paradigms for modeling early-life socioenvironmental factors and SUD-relevant neurocognitive phenotypes, and for which the “toolbox” for cell-specific and temporally precise manipulations of neural circuits is rapidly expanding. The supported programs will also address development of strategies and tools for optimal throughput of data collection and analysis, as well as tools for computational modeling using these data.

Holly Moore, Ph.D., and Janani Prabhakar, Ph.D., Division of Neuroscience and Behavior


Mechanistic Research on Neuromodulation for SUD Treatment

Posted September 2022 

Background

Given the marked heterogeneity in the etiology, pathophysiology and trajectory of substance use disorders (SUD), a toolbox of therapies will be required to mitigate this crisis. In addition to pharmacological, immunological and behavioral therapies, neuromodulation is gaining new interest, particularly given its efficacy in treating disorders that are often comorbid with SUD, such as depression.  Mechanistically guided use of neuromodulation promises to be a new avenue for SUD treatment. Current research on neuromodulation for SUD treatment has been based on knowledge gained from clinical trials and has been limited to specific preselected cortical targets (i.e. DLPFC/OFC) with little understanding of the mechanism of therapeutic effect.  The goal of this RFA is to identify mechanisms by which neuromodulation influences a broader set of cortical targets and related cognitive constructs relevant to SUD treatment.  It promises to identify and validate new neuromodulation targets outside of the clinical trials framework and to provide a more complete understanding of the behavioral and neurobiological effects of stimulation to new identified targets, leading to stronger mechanistic understanding of SUD and its treatment

Goal

In addition to providing direct insight into the causal mechanisms of SUD, the proposed concept would inform subsequent clinical trial design via the identification of both new treatment-relevant targets and selection of more proximal metrics of efficacy in subsequent clinical trials.

Further, a funding opportunity more directly focused on the mechanistic effects of neuromodulation will engage researchers without the background or necessary infrastructure to undertake a full-scale clinical trial.

John Fedota, Ph.D., Division of Neuroscience and Behavior


Advancing Psychedelics Research for Treating Addiction

Posted September 2022 

Background

Recent clinical studies with ketamine, 3, 4-methylenedioxy-N-methamphetamine (MDMA) and classical psychedelics such as lysergic acid diethylamide (LSD), N,N-dimethyltryptamine (DMT), ibogaine, mescaline and psilocybin have provided evidence regarding their therapeutic potential for treating psychiatric disorders. Moreover, observational data and preliminary studies have shown that these compounds induce persistent reductions in cannabis, opioid, and stimulant use thus indicating their potential for treating substance use disorders (SUD). Psychedelics have long been known to modulate the classical neurotransmitter systems while affecting neural, sensory, emotional, and cognitive function. Convergent evidence suggests that their therapeutic potential results from their ability to promote structural and functional synaptic plasticity through modulation of the function of several plasticity-related proteins. Despite such findings, there are prevailing knowledge gaps regarding their precise mechanisms of action on CNS receptors, signaling pathways, and on brain activity and connectivity, especially in the context of SUD. While certain neurobiological mechanisms underlying the physiological and pharmacological actions of psychedelics have been proposed, refinements of additional overarching experimental frameworks are necessary for advancing the field, especially to better understand the translational aspects of psychedelics, including sex differences. Moreover, across cognitive and emotional processes, more precise definitions of the specificity and duration of the post-acute effects of psychedelics are necessary to fully guide their therapeutic use. In addition to animal studies, it is necessary to replicate and extend the basic findings in mechanistic studies in humans since this will establish stronger links between the known pharmacologic effects and the relevant changes in cognitive, emotional, and social processes relevant to human SUD.

Goal

The overarching goal of this concept is to encourage research on mechanisms underlying the physiological and pharmacological actions of psychedelics. There is an emerging interest in the potential of psychedelics as therapeutics agents for neuropsychiatric disorders and for treating addiction. This concept will support basic and clinical research to address key knowledge gaps on psychedelics while encouraging collaborative efforts and multidisciplinary approaches to systematically evaluate the biological targets, mechanisms of action and other translational aspects of psychedelics including their safety, pharmacokinetics/pharmacodynamics, and efficacy, in the context of substance use disorders (SUD). 

Kiran Vemuri, Ph.D.,  and John Fedota, Ph.D., Division of Neurosciences and Behavior


Remote Assessment 1: Identifying and Addressing Barriers to Participant Engagement

Posted September 2022

Background

While recent technological advancements have allowed for greater use of remote assessments in neuroscience research, there has yet to be universal acceptance of these assessments across broad, diverse communities. Barriers to acceptance include, but are not limited to, the technological divide between geographic regions and access to digital spaces, lack of engagement with under-resourced communities, and historic mistrust of healthcare and academic institutions. Acceptance of remote interactions facilitated by technology will help reduce geographic and social barriers to research participation and access to clinical care. Importantly, greater use of remote platforms for research and clinical purposes will provide safety to highly vulnerable participants by removing them from a hospital or high-risk or traumatized setting.

Goal

This concept proposal is designed to investigate and address barriers to help NIDA investigators find avenues to increase participant engagement and retention through remote platforms. Bringing traditionally laboratory- or clinic-based assessments to remote settings requires adequate knowledge of the sociocultural environment within which these assessments are given. As such, this concept emphasizes an interdisciplinary approach to bring together researchers, epidemiologists, statisticians, clinicians, and community collaborators to not only increase inclusion of traditionally underrepresented groups in biomedical research, but to also develop tools that are sensitive to the geographic, social, economic, and organizational components that contribute to participation barriers and SUD outcome disparities. The overarching goal is to build effective community collaboration to ensure that development and deployment of validated virtual assessments adequately serve the community.

Janani Prabhakar, Ph.D. and John Fedota, Ph.D., Division of Neuroscience and Behavior


Remote Assessment 2: Validation and Expansion of Remote Assessments of SUD‐Relevant Behaviors

Posted September 2022

Background

An opportunity exists to leverage the advancement, acceptance, and ubiquity of personal technology to extend the clinical research environment beyond a laboratory-based setting and deeper into a wide range of community settings that better reflect the diversity of the nation.  The COVID-19 pandemic forced the vast majority of ongoing human clinical SUD research to shift rapidly towards some degree of remote data collection.  However, it remains unclear what measures collected outside of the traditional laboratory environment yield robust, reliable data, and how such remotely collected data can be compared and combined with traditional laboratory collected data.  This concept proposes the development of validated measures for low burden home and virtual assessments of SUD relevant data (e.g. subjective clinical instruments, cognitive tasks, environmental characterizations) as well as a concentrated effort to increase the temporal resolution of this data collection.  The exponentially higher temporal resolution over extended durations possible via remote assessment coupled with the use of validated measures and other passive environmental and behavioral characterizations deepens the characterization of SUD relevant phenotypes and better characterizes the interactions between individuals and their environment. 

Goal

The robust, remote data can be employed to better model the relevant behaviors of individuals across society in the natural environment in service of the next generation of SUD interventions.  To achieve this, the current concepts seeks the validation of remote assessment measures by comparing the data collected in laboratory settings to that collected remotely and the integration of data across multiple measures/sensor types to deepen the characterization of interactions between individuals and their natural environment.

John Fedota, Ph.D. and Janani Prabhakar, Ph.D., Division of Neuroscience and Behavior


NIDA International Program

Posted September 2022

Background

Substance use disorders are a global health crisis requiring trained scholars and clinicians around the world. NIDA seeks to contribute to the development of international researchers to collaborate on research and to conduct related activities to facilitate international research to address the problems of drug use, abuse and addiction in the United States and abroad. In past decades, this NIDA contract has supported Hubert H Humphrey Drug Use Research Fellowship, INVEST Postdoctoral Drug Use and Addiction Research Fellowship, and the annual International Forum (in conjunction with CPDD).

Goal

The goals of this program include (1) supporting substance use disorder research, (2) training international postdoctoral or senior researchers, (3) information dissemination, and (4) international policy development.

Lindsey Friend, Ph.D., Health Science Administrator, Office of Research Training Diversity and Disparities


NIH BRAIN Initiative: Brain & Behavioral Quantification and Synchronization

Posted February 2022

Background

Major advances in technology and computational approaches have advanced the study of brain structure and function.  Yet while current neurocognitive research designs typically capture high-resolution neural data, this often occurs in settings that do not solicit or capture complex, adaptive behavior.  Fortunately, there are now tools available that allow for high-resolution, multimodal measurement of behavior that, through computational modeling, can be integrated with simultaneously collected information about the physical, cognitive, and social environment in which the organism is embedded.   Using these advanced approaches, it is possible to develop theoretical and computational models that capture the full complexity and adaptive value of behavior and can lead to more complete and valid models of neurobehavioral function and its alteration by environmental and biological risk factors relevant to illnesses such substance use disorders.

Goal

The Brain-Behavioral Quantification and Synchronization initiative would advance basic research that 1) applies the most innovative technologies to collect high-resolution, multimodal behavioral and physiological data from organisms while also tracking changes in the complex environments in which the organisms are embedded; and 2) develops novel computational modeling approaches to integrate these multiplex data and reveal new insights about behavior.  Behavioral data that could be collected from the organism could include geographic location, posture and muscle configurations, autonomic function, respiratory patterns, speech and other sonic emissions, olfactory signals, and more.  These data would be synchronously collected with data reflecting physical changes and social signals in the organism’s environment.  Research designs that integrate cognitive, ethological, and evolutionary behavioral theories would be encouraged, as would diversity in the species to be studied. An emphasis would be placed on linking organismal and environmental data across levels of analysis collected to develop new computational and predictive models of neurobehavioral function as part of a dynamic complex system interfacing with the organism’s environment. 

Holly Moore, Ph.D., Health Science Officer, Division of Neuroscience and Behavior


Leading Addiction, Diversity, and Discovery in Education and Research (LADDER)

Posted February 2022

Background

The purpose of this program is to create new partnerships and collaborations between under-resourced universities (including Minority Serving Institutions) and the National Institute on Drug Abuse (NIDA) T32 funded institutions to jointly train substance use disorder researchers.  To achieve this goal, support will be provided to eligible domestic institutions that historically serve underrepresented and underserved populations or are in (IDeA)-eligible states (referred to as the home institution) to provide high quality training and mentoring that will prepare and empower scholars to lead the nations’ future substance use and addiction research workforce. Home institutions will partner with one or more NIDA funded T32 programs which would provide summer research experiences. In turn, T32 institutions can use this opportunity to diversify their T32 appointments as well as student body and research programs at large. The proposed research training programs will incorporate didactic, research experiences (in-person and/or virtual), mentoring, and career development elements to prepare trainees to transition to next career stage in substance use and addiction research. 

Goal

  • The purpose of this program is to provide funding for research resources to under-resourced universities for equipment and related costs;
  • Ensure that there is a diverse pool of undergraduate and graduate students who complete their degree, and successfully transition into substance use and addiction research-focused programs (e.g., Ph.D., or M.D./Ph.D., or postdoctoral fellowships) at NIDA funded research intensive institutions;
  • Promote the creation of new partnerships and collaborations between under resourced universities with NIDA T32 funded institutions. 

Albert Avila, Ph.D., Director, Office of Diversity and Health Disparities


Actionable Data to Inform Research‐Driven Decisions (HEAL Initiative Data2Action)

Posted September 2021

Background

Over the last year, the US saw a 30% increase in overdose deaths, totaling the largest number of annual overdoses in history, with 62% linked to synthetic opioids like fentanyl. While overdoses are rapidly increasing, lags in data availability (months or years) hamper efforts to proactively prepare for – or even nimbly react to – overdose surges. There is a need for actionable data to provide a precise picture of trends in opioid use and overdose in communities. Even if data lags are addressed, there are questions of who and how these data will be used to facilitate responses at national, state, and local levels. Enhanced methods of collection, new tools, technologies, or strategic access could offer data sources to inform implementation, to enhance available resources, or reduce opioid use and overdoses.

Goal

The goal of this concept is to attract researchers who have data in hand and new or existing tools or methods to conduct predictive analyses to 1) use data sources that accessible and analyzed on a timescale allowing for predictive and proactive responses and 2) leverage partnerships with key stakeholders to turn research results directly toward decisions and implementation.

Tisha Wiley, Ph.D., Division of Epidemiology, Services, and Prevention Research


Avenir Award Program for Genetics or Epigenetics of Substance Use Disorders

Posted September 2021

Background

Avenir means future in French, and this award supports early-stage investigators proposing highly innovative studies who may lack the preliminary data required for an R01 grant. The award program targets proposals showing principal investigators with promise of being tomorrow's leaders in the field. The precedence for this award has been established by previous NIDA Avenir Award Programs.

Goal

The Genetics or Epigenetics of Substance Use Disorders Avenir Award program supports studies that open new areas of research for the genetics or epigenetics of addiction. These studies may develop novel methods or approaches that can potentially be applied to the analysis of the genetics or epigenetics of addiction. Investigators outside the field of addiction interested in applying their approaches to the genetics or epigenetics of addiction are encouraged to apply.

Jonathan D. Pollock, Ph.D., Division of Neuroscience and Behavior


NIDA Abuse Liability Testing Initiative

Posted February 2021

Background

The NIDA Abuse Liability Testing Program predates all current NIDA employees, and it is not known when the program was initiated. The activities of the program likely predate the establishment of NIDA (in 1974) and may have been supported by NIMH at one time. The Controlled Substances Act of 1970 (Public Law No: 91-513) placed a large number of abused drugs under special controls, and the law also describes the process by which the Department of Health & Human Services and the Drug Enforcement Agency (DEA) should work together to review pharmacological and toxicological data and make decisions regarding the possible control of new drugs. While the law requires data review for each drug under consideration for possible scheduling, it does not address the question of who should generate the necessary data. If a new drug is a potential medication, the FDA requires the relevant pharmaceutical company to generate the data. However, in the case of a new “street drug,” the NIDA Abuse Liability Testing Program usually generates the necessary data. The DEA is responsible for either providing the newly identified street drugs to NIDA or providing funds to support their synthesis, and NIDA has had the primary responsibility for conducing the necessary in vitro and in vivo preclinical testing. Current trends in drug abuse dictate the specific compounds that require testing, and data from DEA street encounters and pathology testing guide compound prioritization. Planning for this testing is a regular topic of discussion at Inter-Agency Committee on Drug Control (ICDC) meetings, where representatives from NIDA, FDA and DEA participate as the core members. Synthetic cathinones (more commonly known as “bath salts”), synthetic cannabinoids, and fentanyl analogs have been recent priorities for testing.

Goal

The continuation of NIDA’s Abuse Liability Testing Program in 2021 and beyond will allow the Federal Government to generate essential pharmacological data to guide scheduling decisions for newly encountered “street drugs.”

David J. McCann, Ph.D., Division of Therapeutics and Medical Consequences


NIDA Drug Supply Program

Posted February 2021

Background

The NIDA Drug Supply Program (NDSP) is administered by the Division of Therapeutics and Medical Consequences (DTMC). In addition to funding research in drug abuse, addiction, prevention, and treatment, NIDA facilitates such research to accomplish its mission by providing chemicals and research probes that are either unavailable, difficult to obtain, or very expensive to buy to researchers. In addition, this program also provides analytical services and limited pharmacokinetic testing for researchers’ experimental samples.

The NDSP provides various controlled drugs, other chemical substances, and marijuana and nicotine research cigarettes for research purposes to investigators working in the area of drug abuse, drug addiction, and related disciplines at academic institutions and research laboratories both within the U. S. and elsewhere worldwide. The availability of controlled substances is regulated by the United States Drug Enforcement Administration (DEA), Department of Justice under the Controlled Substances Act (CSA), and the U.N. Convention on Psychotropic Substances. Materials in the NDSP are prepared, stored, and distributed in full compliance with all local, federal and international regulations. The controlled drugs produced and distributed within the NDSP include hallucinogens, stimulants, sedatives and hypnotics, narcotics, designer drugs, cannabinoids, marijuana, as well as many other categories of controlled substances. The NDSP also maintains an inventory of other chemical substances such as opioid peptides, radio- and mass-labeled compounds, and drug metabolites. In addition, continuous efforts are made to synthesize new compounds and add them to the inventory in response to the developing needs of the research community. The stability and purity of all such compounds are periodically monitored and maintained.

During the last 40 years, the NDSP has provided approximately 20,000 compound shipments to researchers from an inventory of ca. 2,200 batches of more than 900 individual compounds. A group of more than 2,000 investigators have received materials from the NDSP since its inception.

Goal

The continuation of NIDA’s Drug Supply Program in 2021 and beyond will allow the Federal Government to continue to provide DEA controlled and non-controlled compounds that are unavailable, difficult to obtain, or very expensive to buy to researchers. Additionally, state-of-the-art analytical services will continue to be available to researchers that would otherwise struggle to have access to similar resources.

Richard “Rik” Kline, Ph.D., Division of Therapeutics and Medical Consequences