Substance Use & Opioids
Funding for substance use disorder treatment and recovery.
Rural Emergency Medical Services Training
This program recruits and trains EMS personnel to provide immediate emergency care and rapid hospital transport in rural communities. As first responders, EMS personnel deliver life-saving interventions—such as opioid overdose reversal, buprenorphine initiation, CPR, and oxygen administration—helping reduce strain on local hospital resources.
Strategic Prevention Framework - Partnerships for Success for Communities/Tribes
The purpose of the SPF-PFS-Communities/Tribes program is to help prevent and reduce the initiation and progression of substance use and its related problems by supporting the development and delivery of community-based substance use prevention services that strengthen protective factors, reduce risk factors, build resilience, and promote well-being; and expand and strengthen the capacity of prevention providers serving communities and tribes to implement evidence-based, evidence-informed, and community-defined evidence-based prevention strategies.
Sober Truth on Preventing Underage Drinking Act Grants
The purpose of the STOP Act Grants program is to prevent and reduce alcohol use among youth and young adults ages 12 to 20 in communities throughout the United States.
Screening, Brief Intervention and Referral to Treatment
The purpose of this program is to implement the Screening, Brief Intervention, and Referral to Treatment public health model for children, adolescents, and/or adults in primary care and community health settings (e.g., health centers, hospital systems, HMOs, PPOs, health plans, FQHCs, behavioral health centers, pediatric health care providers offices, children’s hospitals) and schools, with a focus on screening for underage drinking, opioid use, and other substance use.
Preventing Drug Overdoses: Community Prevention and Response
The purpose of this program is to develop and implement a community-wide prevention program of drug overdose deaths by expanding access to FDA-approved opioid overdose reversal medications.
State Pilot Program for Treatment for Pregnant and Postpartum Women
The purpose of this program is to strengthen and expand integrated, evidence-based substance use disorder (SUD) and maternal mental health services for pregnant and postpartum women and their families. The program seeks to improve maternal and infant health outcomes by addressing SUD and co-occurring substance use and mental health conditions through comprehensive screening, treatment, recovery supports, and workforce development. Priority populations include pregnant and postpartum women with primary diagnoses of SUDs, including opioid use disorder, and co-occurring mental health conditions, their infants and families, and communities disproportionately impacted by maternal morbidity and mortality.
First Responders-Comprehensive Addiction and Recovery Act
The purpose of the FR-CARA program is to train first responders and communities in administering and distributing FDA-approved opioid overdose reversal medications.
Strategic Prevention Framework - Partnerships for Success for States
The purpose of the SPF-PFS States program is to help prevent and reduce the initiation and progression of substance use and its related problems by supporting the development and delivery of community-based substance use prevention services that strengthen protective factors, reduce risk factors, build resilience, and promote well-being; and expand and strengthen the capacity of prevention providers serving communities and tribes to implement evidence-based, evidence-informed, and community-defined evidence-based prevention strategies.
Behavioral Health Partnerships for Early Diversion of Adults and Youth
The purpose of this program is to develop and implement infrastructure that supports programs that divert adults and/or youth with a mental illness or a co-occurring substance use disorder from the criminal and/or juvenile justice systems prior to arrest and booking.
Promoting Integration of Primary and Behavioral Health Care: States
The purpose of this program is to: promote full integration and collaboration in clinical practices between physical and behavioral health care; support the improvement of integrated care models for physical and behavioral health care to improve overall wellness and physical health status; and promote the implementation and improvement of bidirectional integrated care services, including evidence-based or evidence-informed screening, assessment, diagnosis, prevention, treatment, and recovery services for mental and substance use disorders, and co-occurring physical health conditions and chronic diseases.
Behavioral Health Mobile Crisis Team Partnerships
The purpose of this program is to establish new, or enhance existing, mobile crisis teams that serve children, youth, and adults experiencing mental health or substance use crises. Its focus is the expansion of behavioral health crisis response capacity and the development of structured partnerships that reduce reliance on law enforcement and emergency departments for behavioral health crises.
Grants to Expand Substance Use Disorder Treatment Capacity in Adult and Family Treatment Drug Courts
The purpose of this program is to expand substance use disorder (SUD) treatment and recovery support services in existing drug courts. Grant recipients will be required to implement a coordinated, multisystem approach that combines the legal authority of treatment drug courts with evidence-based SUD treatment services. Key stakeholders include the judiciary, prosecution, defense attorneys, probation services, law enforcement, mental health professionals, social service agencies, and treatment providers. The objective is to disrupt the recurring pattern of criminal behavior, substance use, and incarceration or other legal consequences.
Services Program for Residential Treatment for Pregnant and Postpartum Women
The purpose of this program is to provide comprehensive services for pregnant and postpartum women with substance use disorders across the continuum of residential settings that support treatment and sustain recovery. Treatment and recovery support services should be provided to pregnant and postpartum women and their dependent children who may reside with the women while in treatment.
Medication-Assisted Treatment - Prescription Drug and Opioid Addiction
The purpose of this program is to expand access to medications for opioid use disorder, increasing availability of treatment and recovery for individuals with opioid use disorder, and to reduce illicit opioid use and prescription opioid misuse and overdose.
Emergency Department Alternatives to Opioids
The purpose of the program is to establish and implement practices which will help organizations develop alternatives to pharmacological opioid interventions for pain, reduce the potential harmful consequences of opioid use for pain care in hospitals and emergency departments, thereby promoting safer pain treatment and reducing the risk of future opioid misuse and possible opioid overdose.
Treatment, Recovery, and Workforce Support
The purpose of the Treatment, Recovery and Workforce Support program is to support individuals in substance use disorder or co-occurring disorder treatment and recovery to live independently and participate in the workforce.
Tribal Opioid Response
The purpose of the TOR program is to assist in addressing the opioid overdose crisis in Tribal communities by increasing access to FDA-approved medications for opioid use disorder, and supporting the continuum of prevention, treatment, and recovery support services for opioid use disorder and co-occurring substance use disorders. This program also supports prevention, treatment, and recovery support services for stimulant misuse and use disorders, including those involving cocaine and methamphetamine.
Safety Through Recovery, Engagement, and Evidence-Based Treatment and Support
The purpose of this program is to support comprehensive, street-based engagement, treatment, and recovery support services for individuals experiencing homelessness who have serious mental illness, serious emotional disturbance, substance use disorders, or co-occurring mental and substance use disorders.
Treatment and Recovery Services for Youth, Young Adults, and Families
The purpose of this program is to enhance comprehensive treatment and recovery services for youth (ages 12-17) and young adults (ages 18-25) with substance use disorders and/or co-occurring substance use and mental disorders and their families/primary caregivers.
Preventing Youth Overdose: Treatment, Recovery, Education, Awareness and Training
The purpose of this program is to improve local awareness among youth of risks associated with fentanyl, expand screening and diagnosis for opioid use disorder (OUD) among youth, increase access to medications for opioid use disorder (MOUD) for youth, and train healthcare providers, families, and school personnel on best practices for supporting youth with OUD and those taking MOUD.
Comprehensive Opioid Recovery Centers
The purpose of the program is to establish and implement comprehensive treatment and recovery centers that provide a full continuum of evidence-based treatment and recovery services to address the opioid epidemic, substance misuse, and substance use disorders, including alcohol use disorder.
Screening & Treatment for Maternal Mental Health and Substance Use Disorders (MMHSUD)
The MMHSUD Program helps improve maternal mental health and substance use disorder outcomes for pregnant and postpartum women by providing obstetric, primary care, and other maternal health providers with timely access to teleconsultation, training, and care coordination support including resource and referrals.
Pilot and Feasibility Studies in Preparation for Substance Use and HIV Prevention Intervention and Services Research Trials
The National Institute on Drug Abuse seeks to support pilot and feasibility studies in preparation for efficacy, effectiveness and/or services research trials. Topics may include:1) developing interventions to prevent substance use, misuse or progression to disorder, 2) substance use prevention, treatment or recovery services research, including comorbid pain, medical and mental health disorders, 3) HIV eradication research, including implementation science, prevention, treatment and recovery in substance use settings/populations. Projects may address information gaps, strengthen stakeholder partnerships, or pilot test interventions. Activities might include intervention development/adaptation; assessing intervention or service model acceptability and feasibility; and development of measures, materials, or methods for the future trial. Preliminary data is not required. A well-defined theory of change or logic model is expected. Applicants must engage relevant end users in study design, execution, and interpretation (e.g., policymakers, state and local decision makers, practitioners, individuals with lived/living experience, families, youth, and community members). Applications are not being solicited at this time. This notice is to allow applicants time to develop collaborations and responsive projects. Grant authorities that allow this forecast are 42 U.S.C. §§ 241 and 284.
Providers Clinical Support System – Substance Use Disorder Treatment (PCSS-SUD Treatment)
The purpose of this program is to provide training and technical assistance (TTA), mentoring, and ongoing support for healthcare professionals in general health and behavioral health settings to increase their capacity to identify and treat substance use disorders (SUDs), especially opioid and alcohol use disorders.
Rural Communities Opioid Response Program (RCORP)-Impact
The Rural Communities Opioid Response Program (RCORP)–Impact funds rural communities to drive measurable improvements in access to integrated, coordinated treatment and recovery services for substance use disorder (SUD), including opioid use disorder (OUD). Its long-term aim is to reduce morbidity and mortality associated with SUD and enable sustained recovery and well-being. The program supports: New or expanded evidence-based SUD prevention, treatment, and recovery services in rural areas;Coordination across health and supportive social services to enable sustained, long-term recovery;A larger, more responsive workforce to address SUD-related needs; andMulti-sector community networks to strengthen and sustain local service delivery.The focus of RCORP-Impact is on reducing the impact of opioid misuse on rural America. However, HRSA recognizes that people who misuse opioids often struggle with other substances as well, including alcohol. Therefore, RCORP-Impact supports a comprehensive approach to address all SUD, including OUD, within a continuum of mental, behavioral, and related social supports.
Garrett Lee Smith Campus Suicide Prevention
The purpose of this program is to support a comprehensive public health and evidence-based approach that: (1) enhances behavioral health services for all college students, including those at risk for suicide, depression, serious mental illness (SMI)/serious emotional disturbances (SED), and/or substance use disorders that can lead to school failure; (2) prevents and reduces suicide and mental and substance use disorders; (3) promotes help-seeking behavior and reduces stigma; and (4) improves the identification and treatment of at-risk college students so they can successfully complete their studies. Note: Cost-sharing is waived for minority-serving institutions and community colleges.
Certified Community Behavioral Health Clinic (CCBHC) Improvement and Advancement Grant
The purpose of this program is to sustain and enhance services at existing Certified Community Behavioral Health Clinics serving individuals across the lifespan with or at risk for mental health and/or substance use disorders.
Certified Community Behavioral Health Clinics (CCBHCs) Planning, Development, and Implementation Grant
The purpose of this program is to develop and establish new Community Behavioral Health Clinics to address gaps in behavioral health services and improve the wellbeing of persons with mental health and substance use disorders.
Garrett Lee Smith State/Tribal Youth Suicide Prevention and Early Intervention Program
The purpose of this program is to support States and Tribes in implementing suicide prevention and early intervention strategies for youth, up to the age of 24 years, in schools, educational institutions, juvenile justice systems, substance use and mental health programs, foster care systems, pediatric health programs, and other child- and youth-serving organizations.
Providers Clinical Support System - Universities
The purpose of this program is to fully prepare graduate-level health professional students to understand, identify, intervene, and treat patients with a substance use, misuse and substance use disorder (SUD), upon becoming licensed practitioners. Students will gain the knowledge of the medical consequences of SUD as a chronic illness, evidence-based treatment options, and the impact of recovery supports. Students will gain practical experience working with practitioners treating SUD as well as from individuals living in long-term recovery.
Innovation in Behavioral Health (IBH)
The Innovation in Behavioral Health (IBH) Model (the “Model”) for Cohort II Recipients is a seven-year, voluntary service delivery and payment model promoting integrated care in behavioral health (BH) settings. The IBH Model will test the impact of a value-based payment (VBP) model aligned across Medicaid and Medicare that supports an integrated care delivery framework in specialty BH organizations and settings for adult Medicaid, Medicare, and dually eligible beneficiaries with moderate to severe mental health conditions and/or substance use disorders (SUDs). The Centers for Medicare & Medicaid Services (CMS), through its Center for Medicare & Medicaid Innovation (Innovation Center), will select up to five state Medicaid agencies (SMAs) to participate in the Model. The Model will have a seven-year performance period, which will be comprised of a two-year Pre-Implementation Period (beginning January 2027 and ending December 2028) along with a five-year Implementation Period (beginning January 2029 and ending December 2033). Up to $7.5 million dollars in cooperative agreement award funding will be available to each selected Recipient over the course of the seven years.
Enhancing sustainable health information and laboratory systems and networks for quality detection, management, and monitoring to end HIV and TB as public health threats in India
The Award Ceiling for Year 1 is 0 (none). CDC anticipates an Approximate Total Fiscal Year Funding amount of $6,000,000 for Year 1, subject to the availability of funds. CDC invites proposals to support India’s Ministry of Health and Family Welfare (MOHFW), National AIDS Control Organization (NACO), and related institutions to strengthen health systems and laboratory networks for HIV, TB, and other public health concerns. It aligns with the America First Global Health Strategy (AFGHS) to bolster health systems to prevent the global spread of infectious disease. You should enhance innovative, cost-effective, and quality-assured laboratory services for HIV, TB, and related health programs by focusing on early detection, service delivery, and monitoring in priority regions. Strategic support will foster ownership, integrate broader health systems, and align with U.S. global health priorities. Activities include: Optimizing health information and laboratory networks for HIV, TB, and co-infections to enhance access, early detection, and boost capacity for other public health concerns.Enhancing surveillance of infectious disease threats by integrating national data systems for coordinated public health action.Reinforcing biosafety, biosecurity, and laboratory quality systems.Adopting innovative technologies to meet disease containment goals.Supporting molecular diagnostics and epidemiology to track transmission networks and drug resistance for infectious diseases, focusing on HIV and co-infections.Strengthening the health workforce to collect, analyze, and use data to improve patient care, feedback systems, and epidemic trend monitoring.
HEAL Initiative: Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) - Building Engagement, Assistance, Capacity, Outreach, and Networks (BEACON) Center
40-75% percent of individuals with opioid use disorder (OUD) have co-occurring chronic pain (CP), which impacts their ability to fully engage in treatment. Effective management of both conditions is hindered by siloed medical disciplines and health systems. HEAL Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR) was funded in FY21 to test novel interventions for the management of co-occurring CP and OUD at the patient level. This initiative will test different implementation strategies and other approaches to address scalability and sustainability of evidence based practices for CP and OUD from a health system perspective. Studies will engage key decision leaders in health systems including but not limited to: peer specialists, clinicians, health system leaders, and payers. Studies will execute a single hybrid II/III implementation-effectiveness trial to focus on collaborative care models and implementation strategies to meaningfully integrate CP and OUD service provision in diverse health settings. These studies will address complex factors that influence the ability to scale and sustain effective and integrated care for CP and OUD. The BEACON Center will provide: (1) network coordination support, (2) capacity building at the intersection of CP, OUD, and implementation science, (3) annual surveys/qualitative activities to understand different barriers and attitudes impacting access and sustained use to integrated CP and OUD service delivery, (4) develop important resources for key stakeholder audiences that can inform/improve sustainability and scalability of evidence-based practices. The National Institute on Drug Abuse (NIDA) in partnership with National Institute on Alcohol and Alcoholism (NIAAA), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Mental Health (NIMH), and National Center for Complementary and Integrative Health (NCCIH), and National Institute of Neurological Disorders and Stroke (NINDS) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for research on the effective management of OUD and CP. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the U2C activity code. Investigators with expertise and insights into this area of CP management and OUD/opioid misuse are encouraged to begin to consider applying for this new NOFO. In addition, collaborative investigations combining expertise in community-based participatory research approaches, implementation science, and other strategies to amplify scalability and sustainability will be encouraged and, these investigators should also begin considering applying for this NOFO. Grant authorities that allow NIDA to forecast this opportunity are as follows: 42 U.S.C. § 241 and § 284.
Novel approaches to support therapeutic development in ultra-rare cancers
The purpose of this program is to support new approaches that can be applied to facilitate therapeutic development in ultra-rare pediatric and adult cancers, including molecularly-defined subsets of more common cancers. Specific areas of interest include, but are not limited to, the following examples: • Development of infrastructure for a coordination network and data repository for patient-level data across institutions and internationally to support drug development and regulatory decision-making for one or more ultra-rare cancers. • Investigations to explore opportunities to develop and validate early clinical endpoints and other novel efficacy endpoints for evaluation of treatments for ultra-rare cancers. • Development and implementation of a collaborative multi-stakeholder effort to support generation and use of real-world data leveraging a registry framework for use in development of new therapies for pediatric patients with diffuse midline glioma (DMG) (including diffuse intrinsic pontine glioma, DIPG). • Innovative approaches to identify new biologically-driven opportunities for clinical development of previously approved drugs or biologics (hereafter referred to as drugs), including drugs for which development has been discontinued, in ultra-rare cancers. • Research to develop novel approaches to preserve the availability of drugs for which commercial developers have discontinued adult development that have strong potential in ultra-rare cancers but lack financial incentives for commercial development • Development of methods to incorporate use of telemedicine and/or pragmatic trial design elements (e.g., collecting laboratory and/or imaging data from local facilities) for patient assessments to facilitate enrollment of patients with ultra-rare cancers • Development of nanoparticle-based delivery approaches for therapeutic nucleic acids targeting onco-fusion transcription factors in metastatic tumor animal models using targeted bioPROTAC degradation or genomic editing strategies. Successful efforts should demonstrate effective delivery and expression in-vivo to tumor cells, and downregulation of the target transcription factor protein while minimizing off-target effects and limiting sequestration of the nanoparticle by the liver, spleen, and lungs. • Research to exhaustively characterize the plasma-membrane protein expression (surfaceome) of an ultra-rare cancer and the presumed healthy tissue of origin, as well as the resident-tissue stem cells, by single-cell transcriptomics and proteomics. These studies, and available correlative database analyses, should be designed to identify possible combinatorial signatures of plasma membrane proteins unique to the ultra-rare tumor. Tumors of interest include Sclerosing epithelioid fibrosarcoma and atypical teratoid rhabdoid tumors (ATRT).
HEAL Initiative: Integrative Management of Chronic Pain and Opioid Use Disorder (OUD) for Whole Recovery: Health Systems
Forty to sixty percent of individuals with opioid use disorder (OUD) have co-occurring chronic pain (CP), which impacts their ability to fully engage in treatment. Effective management of both conditions is hindered by siloed medical disciplines and health systems. HEAL Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR) was funded in FY21 to support 11 unique clinical trials to test novel interventions for the management of co-occurring chronic pain and OUD at the patient-level. The current NOFO will develop strategies to address barriers to the sustainable and effective delivery of integrated OUD/pain care at the health systems level. IMPOWR identified patient interventions that were effective and ready to implement. The current NOFO will address how health systems could be improved to facilitate the use of effective integrative interventions, including the involvement and roles of peer specialists, clinicians, health system leaders and other key decision makers. Also, this NOFO will characterize where such care can be optimally and efficiently delivered. Studies will identify collaborative care models, implementation strategies, and other innovative health system approaches to meaningfully integrate CP and OUD service provision in health settings. These studies will address complex factors that influence the ability to scale and sustain effective collaborative and integrated care for pain and OUD. The National Institute on Drug Abuse (NIDA) in partnership with National Institute on Alcohol and Alcoholism (NIAAA), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Mental Health (NIMH), and National Center for Complementary and Integrative Health (NCCIH), and National Institute of Neurological Disorders and Stroke (NINDS) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for research on the effective management of OUD and CP. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the RM1 activity code. Investigators with expertise and insights into this area of chronic pain management and OUD/opioid misuse are encouraged to begin to consider applying for this new NOFO. In addition, collaborative investigations combining expertise in community-based participatory research approaches, implementation science, and other strategies to amplify scalability and sustainability will be encouraged and, these investigators should also begin considering applying for this NOFO.
Molecular, Neural, and Cognitive Mechanisms of Non-Invasive Brain Stimulation to Treat Substance Use Disorders
The National Institute on Drug Abuse (NIDA) intends to publish a Notice of Funding Opportunity (NOFO) to encourage basic research on Non-Invasive Brain Stimulation (NIBS) using animal and human models. NIBS techniques transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), and transcranial focused ultrasound (tFUS) have emerged as promising approaches to treat addiction and substance use disorders (SUDs); however, their mechanisms of action are unclear. This initiative is to support research to (1) elucidate molecular, cellular, and circuit level changes induced by NIBS protocols (2) identify molecular mechanisms and pathways by which NIBS techniques and protocols produce their therapeutic effects in SUDs,(3) identify novel clinical targets for NIBS, and (4) investigate SUD-relevant neurobiological, cognitive, and behavioral responses to NIBS that may precede clinical outcomes. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Investigators with expertise and insights into neuromodulation by non-invasive brain stimulation are encouraged to apply. In addition, collaborative investigations combining expertise in non-invasive brain stimulation and substance use and addiction are encouraged.
Avant Garde/Avenir award for Investigators conducting high risk/high reward research on HIV and Substance Use (or Substance Use Disorders)
The National Institue on Drug Abuse (NIDA) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for research on pioneering research in HIV and Substance use/substance use disorder (SUD) research. The Avant-Garde Award Program is designed to support exceptionally creative scientists who propose cutting edge high risk and high reward and possibly transformative approaches to major challenges in biomedical and behavioral research on HIV in the context of substance use and/or SUDs. This Program includes supporting early stage investigators (ESI). Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the DP1 activity code. Investigators with expertise and insights into this area of substance use and HIV are encouraged to begin to consider applying for this new NOFO.
Limited Competition for the Continuation of the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) Data Analysis Resource (U24 Clinical Trials Optional)
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) launched the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) in 2012 to determine how adolescent alcohol-related disruption of normal brain growth patterns of structure, related brain function, and psychiatric health affects brain functioning in emerging adulthood. The consortium uses an accelerated longitudinal design and has acquired data on over 800 individuals between the ages of 12 to 32 years. This wide age range covers the period before onset of drinking, the transition from adolescence to young adulthood, the critical period for binge drinking, and the time of maturing out. This unique dataset provides novel information on the enduring and transient consequences of adolescent drinking on adult brain function and behavior. Current studies on adults drinking do not have this type of data. Renewal of this limited competition NOFO will enable NCANDA to continue to follow these participants up to 37 years of age and acquire data critical to understanding how early versus late onset drinking during adolescence differentially impacts drinking behavior in adulthood. This limited competition renewal will provide valuable information for developing evidence-based alcohol prevention strategies and early intervention approaches to prevent the progression to more severe drinking and AUD thereby preventing the development of chronic disease, improving health outcomes, and increasing quality of life and longevity. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the U24 activity code. Investigators with expertise and insights into this area of integrative neuroscience are encouraged to begin to consider applying for this new NOFO.
Limited Competition for the Continuation of the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) Administrative Resource (U24 Clinical Trials Optional)
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) launched the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) in 2012 to determine how adolescent alcohol-related disruption of normal brain growth patterns of structure, related brain function, and psychiatric health affects brain functioning in emerging adulthood. The consortium uses an accelerated longitudinal design and has acquired data on over 800 individuals between the ages of 12 to 32 years. This wide age range covers the period before onset of drinking, the transition from adolescence to young adulthood, the critical period for binge drinking, and the time of maturing out. This unique dataset provides novel information on the enduring and transient consequences of adolescent drinking on adult brain function and behavior. Current studies on adults drinking do not have this type of data. Renewal of this limited competition NOFO will enable NCANDA to continue to follow these participants up to 37 years of age and acquire data critical to understanding how early versus late onset drinking during adolescence differentially impacts drinking behavior in adulthood. This limited competition renewal will provide valuable information for developing evidence-based alcohol prevention strategies and early intervention approaches to prevent the progression to more severe drinking and AUD thereby preventing the development of chronic disease, improving health outcomes, and increasing quality of life and longevity. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the U24 activity code. Investigators with expertise and insights into this area of developmental neuroscience are encouraged to begin to consider applying for this new NOFO.
Forecast to Publish a Funding Opportunity Announcement for Limited Competition for the Continuation of the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) Research Project Sites (U01 Clinical Trials Optional)
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) launched the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) in 2012 to determine how adolescent alcohol-related disruption of normal brain growth patterns of structure, related brain function, and psychiatric health affects brain functioning in emerging adulthood. The consortium uses an accelerated longitudinal design and has acquired data on over 800 individuals between the ages of 12 to 32 years. This wide age range covers the period before onset of drinking, the transition from adolescence to young adulthood, the critical period for binge drinking, and the time of maturing out. This unique dataset provides novel information on the enduring and transient consequences of adolescent drinking on adult brain function and behavior. Current studies on adults drinking do not have this type of data. Renewal of this limited competition NOFO will enable NCANDA to continue to follow these participants up to 37 years of age and acquire data critical to understanding how early versus late onset drinking during adolescence differentially impacts drinking behavior in adulthood. This limited competition renewal will provide valuable information for developing evidence-based alcohol prevention strategies and early intervention approaches to prevent the progression to more severe drinking and AUD thereby preventing the development of chronic disease, improving health outcomes, and increasing quality of life and longevity. Applications are not being solicited at this time. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the U01 activity code. Investigators with expertise and insights into this area of developmental neuroscience are encouraged to begin to consider applying for this new NOFO.
HEAL: Translating Addiction Epidemiology, Prevention, Treatment, and Recovery Research into Practice (R61/R33 - Clinical Trial Optional)
The National Institute on Drug Abuse (NIDA), with other NIH Institutes, intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications to support action-oriented research that accelerates the translation of addiction epidemiology, prevention, treatment, and recovery research to practice addressing both the opioid crisis and overdose events. Research supported under this initiative would focus on identifying and characterizing malleable factors and addressing barriers or facilitators to reducing substance use, misuse and overdose deaths at the individual, provider, organizational, community, or system levels. The emphasis would be on exploring and developing effective, replicable, and scalable approaches for accelerating the movement of evidence-based and promising treatments and preventive interventions into routine use. Specific priority areas would include, but not be limited to: recovery, prevention, pain/addiction intersections, engaging family and loved ones, transitions across care settings (e.g., inpatient treatment to community treatment), mental health integration, improving quality and efficiency of existing services and interventions, examining substance use and health outcomes and meaningful real-time data capture and use to improve services and public health approaches to reducing substance use, misuse, addiction, and overdose. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the R61/R33 activity code. Investigators with expertise and insights into this area of addiction epidemiology, prevention, treatment, recovery and health services research are encouraged to begin to consider applying for this new NOFO. In addition, collaborative investigations combining expertise in modeling, health economics, implementation science, translation, or engagement science will be encouraged, and these investigators should also begin considering applying for this application.
Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed
To develop, disseminate, implement, and evaluate research needed in Anesthesia, Addiction Medicine and Pain Medicine in various fields of research. Specifically, research is needed in the following fields: function as a clinical trial endpoint and measurement of function in patients with chronic pain, outcome measures for clinical trials in stimulant use disorders, assessment of opioid clinical trials with active control in addition to placebo, neurodevelopmental outcome assessment of vulnerable pediatric patients exposed to anesthesia and opioid, and a living systematic review of pre-clinical studies of anesthetic neurotoxicity. Multiple awards may be considered. Applicants must propose a comprehensive evidence-based plan that advances appropriate prescribing of drug products intended for analgesia, anesthesia, and substance use disorders.
Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)
The U.S. Food and Drug Administration (FDA) seeks applications to develop, implement, and evaluate a human abuse potential (HAP) study of botanical Kratom. FDA has previously warned consumers about the use of Kratom (Mitragyna speciosa), a plant indigenous to Southeast Asia. Kratom alkaloids have demonstrated both affinity and activity at receptor sites known to be associated with abuse, such as mu opioid receptors. Although Kratom use is prevalent, to date, clinical evaluations of its abuse potential have been limited. The proposed HAP study should be performed in accordance with the guidance for industry, "Assessment of Abuse Potential of Drugs," including (but not limited to) the selection of an appropriate comparator(s) and outcome measures, statistical analyses etc. Interested parties, will also complete the submission of an Investigational New Drug (IND) application and obtain Institutional Review Board (IRB) clearance.
Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed
Modified release (MR) oral drug products are considered to have a high risk for alcohol dose dumping (ADD) because they contain large quantities of drug(s), designed to release over a prolonged period of time. Accidental exposure of these products to alcohol can result in the relatively rapid release of large quantities of drug with severe side effects, including death. To mitigate this risk, the FDA recommends conducting an in vitro alcohol dose dumping assessment in 0%, 5%, 20%, and 40% alcoholic dissolution media for all prospective generic versions of MR oral drug products. To date, ADD assessments have not been harmonized globally. For instance, the U.S. FDA recommends testing up to 40% alcoholic media while the European Medicines Agency recommends testing up to 20% alcoholic media. This type of difference can present a challenge for formulators designing products for multiple markets, as historical data has shown release from MR oral products do not always follow a linear response (either increasing or decreasing) to increasing alcohol concentrations. In addition, interpretation of an ADD assessment may be limited by the inability of the test to predict in vivo behavior. The purpose of this research is to develop tools that 1) facilitate the development of MR generic drug products that have a low potential for ADD, 2) support regulatory decision making during the assessment of such products, and 3) provide evidence that enables FDA to develop more specific recommendations for efficiently demonstrating a low or comparative potential of alcohol dose dumping for MR oral drug products containing high risk drugs.
Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional
The purpose of this funding opportunity is to examine the utility of an in vitro simulated gastrointestinal (GI) dissolution model for the assessment of in vitro performance of amorphous solid dispersion (ASD) drug products under different clinically relevant conditions. The goal is to develop and validate the in vitro mechanistic methodology to provide an improved understanding of impact of food and acid reducing agents on the absorption for test and reference listed drug (RLD) drug products, taking into consideration their potentially different formulations and manufacturing. The bio predictive in vitro mechanistic methodology is intended to correlate the in vitro observations to in vivo outcomes, help define types of in vivo bioequivalence (BE) studies needed for ASD drug products, and inform regulatory decision-making related to mitigating the risk of potential failure modes for therapeutic equivalence for high-risk generic oral drug products.
Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed
Computational fluid dynamics (CFD) has played a crucial role in providing an alternative bioequivalence (BE) approach for generic orally inhaled drug products (OIDPs), in addition to comparative clinical endpoint or pharmacodynamic BE studies, as a relatively cost- and time-efficient complement to benchtop and clinical experiments that has been widely used in developing and assessing generic inhaler devices. However, despite the advances in the power of modern computers, there are still some bottlenecks in using CFD due to computational time, limited grid resolution, pre- and post-processing of large simulation data sets, model parameter estimations, and uncertainty quantifications. Machine learning (ML) has been gaining more attention as a potential tool to alleviate such limitations that arise in CFD. The purpose of this grant is to develop a methodology to integrate ML with CFD models of OIDPs to promote alternative BE studies to enhance and accelerate the development and approval of generic OIDPs.