Key Dates

Related Announcements

PA-20-183 - NIH Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-20-184 - NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)

PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

Issued by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Purpose

The purpose of this Notice of Special Interest (NOSI) is to advance research on various topics that fall within NIAAA’s Division of Treatment and Recovery Research (DTRR). DTRR’s research interests are wide-ranging and encompass broad categories such as health services, behavioral therapies and mechanisms of behavioral change (MOBC), recovery, translational research, and innovative methods and technologies for alcohol use disorder (AUD) treatment and sustaining recovery. Other areas of interest include topics focusing on special-emphasis and underserved populations, including NIH-designated U.S. health disparity populations, as well as those with co-occurring disorders; and fetal alcohol spectrum disorders (FASD). In all studies, at all levels from FASD to elderly, efforts will be made to include participants that reflect the diversity of the population at large.

Background

 In the United States, 59 million people exceeded heavy drinking limits within the past year, and 15 million adults were diagnosed with AUD. Unfortunately, of those 15 million, only one in 10 received formal treatment for AUD. Those who did receive treatment rarely received the full range of evidence-based treatment options. Currently, less than 4 percent were prescribed medications approved for the treatment of AUD by the U.S. Food and Drug Administration.

DTRR’s research portfolio seeks to increase the proportion of individuals with AUD who receive appropriate, evidence-based treatment by supporting research across a broad range of topic areas and populations, as described in detail below.

Broad Research Topics

Health Services

Alcohol health services research seeks to bridge the gap between those who need treatment and those who receive treatment. DTRR’s health services research portfolio focuses on four main areas: 1) make evidence-based treatment more accessible to patients; 2) make treatment settings more appealing to patients; 3) make treatments more affordable; and 4) disseminate and implement evidence-based behavioral and pharmacological treatments into professional healthcare practices. Examples of topics of interest to DTTR include, but are not limited to, investigations that:

• Improve access to evidence-based treatments by identifying and developing strategies to reduce the barriers (personal and structural) that prevent people with AUD and alcohol misuse from seeking and receiving appropriate care.
• Explore the treatment gap as it relates to gender, age (from adolescence through older adulthood), race/ethnicity, socio-economic status, immigration status, and health literacy, and improve service delivery systems and innovations to facilitate access to care.
• Remove the stigma of AUD and integrate AUD treatment into mainstream health care.
• Explore the effectiveness of multi-disciplinary health care teams (e.g., behavioral health specialists, nurses, health educators) in primary care and other specialty settings (e.g., gastroenterology, cardiovascular medicine, internal medicine, obstetrics and gynecology, pediatrics, orthopedics, and emergency departments).
• Determine the cost and cost-effectiveness of treatment interventions and explore ways to make the costs more affordable to patients seeking treatment.
• Investigate the effectiveness of treatments by identifying, developing, and testing models and methods to enhance the dissemination, implementation, adoption, adaptation, and sustainability of evidence-based alcohol-related treatment practices (medications and behavioral therapies) across the full spectrum of services, including residential and at-home treatment settings. This increased awareness will allow healthcare professionals and their patients to select from a menu of treatments options and better address the heterogeneity of AUD.
• Explore the use of hybrid designs to simultaneously examine facilitators and challenges affecting implementation, process, and program effectiveness to expedite the translation of evidence-based treatment into real-world practice.

Behavioral Therapies and Mechanisms of Behavior Change

The alcohol treatment field has made enormous progress in developing and evaluating behavioral treatments for heavy drinking and AUD. Despite these advances, little is known about how to successfully disseminate and implement empirically-supported behavioral treatments for AUD within real-word addiction treatment settings. Research over the past 15 years focusing on mechanisms of behavior change (MOBC) has helped to better define how specific behavioral treatments for AUD are most likely to work (e.g., through behavior change related to self-efficacy and therapeutic alliance). But a gap exists between our understanding of the way treatments work and how best to translate those therapies into practice. NIAAA encourages research that can help identify, evaluate, and disseminate empirically-supported MOBC best practices. Research is especially needed to develop and disseminate models for putting behavioral treatments for AUD into practice in a broad range of settings and for use by the full range of professionals involved in treatment (e.g., addiction specialists, counselors, social workers, criminal justice professionals, pediatricians, and mental health and medical practitioners).

Examples of research topics include, but are not limited to, investigations that:

• Evaluate evidence-based behavioral therapies in real world treatment settings, especially for culturally diverse and special emphasis and underserved populations.
• Disseminate clinical practice findings from MOBC studies that have shown promise in enhancing the effectiveness of behavioral therapies.
• Use dynamic and person-centered statistical modeling approaches to evaluate how heterogeneity impacts alcohol use behavior within specific AUD treatments.
• Conduct micro-intervention studies that seek to isolate and test the importance of key treatment-related mediators and moderators.
• Engage in complex research designs (e.g., dismantling studies) that enhance support and evidence for established mechanisms of AUD behavioral treatments.

Recovery

NIAAA’s updated definition of recovery recognizes the importance of both recovery from DSM-5 AUD criteria and cessation of heavy drinking (https://www.niaaa.nih.gov/division-treatment-recovery-research) ). Researchers are encouraged to use this definition as a framework in new recovery studies. Examples of research topics include, but are not limited to, investigations that:

• Explore the neurobiological, medical, psychological, environmental, and social factors that influence post-treatment recovery.
• Define and measure dimensions of functioning and well-being associated with recovery. Which of these dimensions of functioning and well-being are the most integral in recovery? To what degree might these functioning measures be feasibly implemented in clinical practice?
• Explore the relationship between relapse severity/frequency/timing in the recovery process and the likelihood of long-term recovery and improvement of functioning outcomes. This includes defining, assessing, and validating measures of partial recovery that might denote progress in recovery short of full recovery.
• Conduct research that evaluates how established treatment techniques and MOBC from current empirically-supported behavioral treatments can be incorporated into the recovery process to understand how to maintain positive recovery outcomes.
• Determine the trajectories of recovery in subgroups of people with different cultural and socioeconomic backgrounds, cognitive abilities, and medical histories, including examining gender-related differences in trajectories of recovery within these groups.
• Identify the factors associated with so-called spontaneous or “natural” recovery and how these factors can be applied to change the behavior of those in treatment.
• Explore continuing care treatments and interventions that aim to support long-term recovery.
• Develop and utilize large treatment data sets that have long-term treatment follow-ups.
• Establish a registry to follow patients’ long-term recovery after receiving initial treatment

Translational Research

Clinical research examines the neurobiological, cognitive, and genetic processes underlying addiction and offers ways for applying those findings to practice and predicting treatment outcomes. Examples of research topics include, but are not limited to, investigations that:

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• Translate key neuroscience research findings (e.g., neurobiological, cognitive, genetic) to develop more effective treatments.
• Translate research on risk/recovery pathway models to optimize and personalize treatment and predict sub-population (e.g., sex/gender, health disparities, comorbidity, multi-morbidity) continuum of alcohol use outcomes and/or other health impacts.Examine ways to adopt interventions that have been shown to be useful in a research environment for routine clinical care.

Innovative Methods and Technologies for AUD Treatment and Recovery
New technology (e.g., mobile, computer, web-based applications, artificial intelligence (AI)/machine learning, geo-locations, and robotics) has the potential to expand both the accessibility and effectiveness of a variety of treatments and interventions. Research is needed to further advance digital technology for the diagnosis, intervention, treatment, and maintenance of recovery from AUD. Developing new analytical approaches is critical for evaluating treatments, such as tracking results in subpopulations of people with AUD, comparing linear and dynamic models of clinical findings, conducting trajectory analysis and growth mixture modeling to capture changes in recovery over time, and developing and implementing adaptive clinical trial designs and statistical analyses. Examples of research topics include, but are not limited to, investigations that:

• Use new technologies (e.g., mobile devices, computer, web-based applications, AI/machine learning, geo-locations, and robotics) to disseminate evidence-based behavioral treatments among hard-to-reach populations, improve effectiveness of telemedicine, and enhance the continuum of care.
• Investigate new digital technology ways of capturing real-time data in clinical trials and treatment protocols (e.g., interactive voice response technology, smartphones, alcohol sensors, geospatial mapping).
• Explore new analytical methods for evaluating treatment and recovery.
• Explore ways of combining data from clinical trials with that of other studies (e.g., genomic, proteomic, metabolomic) to create more personalized treatment for the individual patient (i.e., to further advance precision medicine).

Special-Emphasis Populations

Health Disparities

AUD research to examine health disparities typically has not kept pace with other areas of investigation and there is a need for more research to develop and implement effective behavioral treatments for vulnerable populations. It is important to understand how the social determinants of health (i.e., environmental, social, cultural, and economic factors) influence outcomes and sustainability of effects. In addition, there is a need for more research to identify and address unique barriers to healthcare access among underrepresented and underserved populations, including stigma, mistrust, and bias, gender, socioeconomic status, educational and health literacy levels, language barriers, and immigration status. There is a need for greater emphasis on developing novel, accessible, cost-effective, culturally grounded interventions in partnership with communities, in addition to adapting existing mainstream interventions for use by diverse populations. Examples of research topics include, but are not limited to, investigations that:

• Remove barriers that keep racial, ethnic, and sex/gender minorities from seeking and receiving appropriate health care.
• Implement effective treatments that are tailored for these populations in diverse clinical and other settings.
• Determine how social/cultural factors influence treatment accessibility, effectiveness, and long-term recovery.

• Develop measures to assess care delivery models to better address the issues underlying health disparities (e.g., health literacy, access to health care, confidence in the proximal health system, socioeconomic status, sociocultural beliefs and practices related to alcohol use, multi-morbidity with other health issues, and personal health care).

AUD Patients with Psychiatric and Substance Abuse Comorbidity

AUD patients often suffer from comorbid psychiatric and substance abuse. Psychiatric disorders frequently comorbid with AUD include depression, anxiety, posttraumatic stress disorder (PTSD), insomnia, bipolar disorder, and schizophrenia. This population experiences poorer treatment outcomes, and tends to have higher rates of clinical impairment, psychosocial and medical problems, utilization of health services, and suicide, as well as lower quality of life than patients who suffer from AUD alone. Developing comprehensive and individualized treatment strategies for persons with comorbid AUD is essential for treating their complex problems. For example, how can we effectively integrate treatments for mental health disorders and AUD? How does treatment of one disorder affect the outcome of the other? How do the disorders interact to increase the severity and clinical course of each disorder? Examples of research topics include, but are not limited to, investigations that:

• Integrate treatment for co-occurring AUD and mental health conditions to address the heterogeneity that exists among patients. Explore how behavioral interventions and medications can be combined to treat AUD patients with co-occurring PTSD, anxiety, serious mental illness, or insomnia, including timing of interventions (serial vs. concurrent), separate vs. fully integrated treatment, and dose/frequency of treatment components.
• Identify which types of services, service providers, and treatment settings work best for which subgroups.
• During the co-occurrence of AUD and psychiatric disorders, determine how the treatment of one disorder can influence the risks, progression, and outcomes for the other disorder.

Women

Historically men have tended to drink at higher rates and experience more alcohol-related problems than women. However, in recent years, the gender gap has narrowed. Women are increasingly likely to have rates of drinking and heavy drinking similar to those observed in men, to be diagnosed with AUD, and to experience the negative consequences of drinking (such as car crashes). Moreover, many of alcohol’s harmful physiological effects have been found to occur more rapidly and severely in women than men. This includes blackouts, liver inflammation, brain atrophy, cognitive deficits, certain cancers, negative affect during withdrawal, and stress and anxiety-induced relapse. More research is needed to better understand sex differences in alcohol use and alcohol-related consequences. Examples of research topics include, but are not limited to, investigations that:

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• Develop new strategies for alcohol screening, diagnosis, and interventions; and tailor them to women in diverse settings, including prenatal care and specialty health care.
• Examine the effects of stress, early childhood trauma/childhood adverse events, and co-occurring disorders on women’s drinking.
• Determine the effectiveness of standard treatment approaches, such as group counseling and relapse prevention, in single-gender vs. mixed-gender groups.
• Develop innovative strategies to improve coordination of care for women and their families across alcohol treatment services and other components of integrated health systems.

Adolescents and Young Adults

Although recent data show that U.S. adolescents in general are drinking less alcohol, when they do drink, they consume alcohol in ways that are particularly harmful. Many young adults are also drinking heavily and experience myriad associated negative consequences. These include an increased risk for alcohol overdose, blackouts, falls, drowning, unplanned sexual encounters, intimate partner violence, and co-occurring mental health conditions. Epidemiological data clearly show an association between early onset of drinking (particularly before age 14) and later alcohol-related problems. Finally, research also shows that alcohol may cause changes in the developing brain. Because the human brain continues to develop past adolescence and into young adulthood, young people are at particularly high risk for experiencing alcohol-related harms. Future research needs to examine whether alcohol-related brain changes occurring in adolescence and young adulthood have long-term consequences. Research also needs to examine how treatment strategies can be better tailored to this special population. Examples of research topics include, but are not limited to, investigations that:

• Develop and test integrated behavioral treatments in adolescents and young adults with AUD that are tailored to the developmental, biological, neurocognitive, psychological, emotional, and social needs of these ages.
• Develop intervention models that determine key elements necessary to achieve and sustain resolution of AUD.
• Develop intervention strategies that examine risk/recovery pathways and the role of behavioral phenotypes on outcomes.
• Test novel approaches (e.g., sequential, multiple assignment, randomized trials–[SMART] trials)to adapt interventions at the individual level and/or account for comorbidity (e.g., mental health, stress, sleep) and cultural or other  considerations. By tailoring variables and the intervention components within the same trial, SMART trials can provide more accurate estimates of effectiveness in terms of subgroup response rates and who benefits the most from specific types of interventions.

Older Adults

In the United States, 1 in 10 older adults engage in binge drinking. Alcohol misuse is increasing in this population, in both men and women, with potentially serious consequences. Drinking among older adults contributes to accelerated aging in some brain regions, including the frontal cortex, leading to impaired cognitive function and resulting in deficits in learning, memory, and motor function. Developing and evaluating early intervention approaches may help to stem these brain effects. Examples of research topics include, but are not limited to, investigations that:

• Develop screening and behavioral and pharmaceutical therapies targeted to older adults.
• Identify vulnerabilities in high-risk subgroups of older adults, including those with comorbidities, women, people with cultural, socioeconomic, immigrant, sex/gender minority status, and people at high risk for adverse medication interactions due to polypharmacy.

Fetal Alcohol Spectrum Disorder (FASD)

Prenatal alcohol exposure can cause a range of intellectual and behavioral problems, including executive function deficits, poor working memory, learning problems, impulse control problems, attention deficits, communication issues, and poor social skills. These problems can appear at any time during childhood and last a lifetime. Recent studies estimate that about 1 to 5 percent of U.S. first-grade children have FASD. Developing and evaluating novel therapeutic approaches for use in prenatal and childhood conditions can help improve the health and quality of life for individuals with FASD. Examples of research topics include, but are not limited to, investigations that:

• Develop and evaluate novel prenatal therapeutic approaches, medications, and dietary supplements for both the fetus and the pregnant mother.
• Pursue various interventions to mitigate the neurocognitive and behavioral deficits associated with FASD across the lifespan.
• Determine approaches to improve access to care and implementation of evidence-based interventions and access to care for individuals with FASD.

Application and Submission Information

This notice applies to due dates on or after October 5, 2020 and subsequent receipt dates through September 8, 2023. 

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PA-20-183 - NIH Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-20-184 - NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
• PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
• PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-AA-20-022” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

For general inquiries and those specific to Behavioral Treatment Development/Mechanisms of Behavior Change and Recovery portfolios contact:
Brett T. Hagman, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Division of Treatment and Recovery Research (DTRR)
Telephone: 301-443-0638
Email: [email protected]

For inquires specific to Health Services/Implementation Science portfolios contact:
Laura Kwako, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Division of Treatment and Recovery Research (DTRR)
Telephone: 301-451-8507
Email: [email protected]

For inquires specific to Women’s Issues, Co-occurring Psychiatric Disorders (Depression, Anxiety Disorders, PTSD, Bipolar Disorder, and Schizophrenia), Health Disparities, and FASD portfolios contact:
Deidra Roach, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Division of Treatment and Recovery Research (DTRR)
Telephone: 301-443-5820
Email: [email protected]

For inquires specific to Adolescents/Young Adults, Older Populations, Translational Research, Innovative Methods and Technologies for AUD Treatment and Recovery, Co-Occurring Substance Abuse and PTSD, and Insomnia portfolios contact:
Mariela Shirley, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Division of Treatment and Recovery Research (DTRR)
Telephone: 301-402-9389
Email: [email protected]

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Ms. Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]