DEPARTMENT OF HEALTH AND HUMAN SERVICES

NATIONAL INSTITUTES OF HEALTH

NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

158th Meeting of the

NATIONAL ADVISORY COUNCIL ON ALCOHOL ABUSE AND ALCOHOLISM

September 9, 2021

The National Advisory Council on Alcohol Abuse and Alcoholism (NIAAA) convened for its 158th meeting at 12:15 p.m. on Thursday, September 9, 2021, via Zoom videoconference and NIH Webcast. The Council met in closed session from 11:00 a.m. to 11:45 a.m. to review grant applications and cooperative agreements. Dr. Abraham Bautista, Director, Office of Extramural Activities, presided over the Council’s review session, which, in accordance with the provisions of Sections 552b(C)(6), Title 5, U.S.C., and 10(d) of Public Law 92-463, excluded the public for the review, discussion, and evaluation of individual applications for Federal grant-in-aid funds. The closed session recessed at 11:45 a.m.

Council Members Present:

Nancy Barnett, Ph. D.
Jill B. Becker, Ph.D.
Andrew MacGregor Cameron, M.D., Ph.D.
Christopher S. Carpenter, Ph.D.
Christina Chambers, Ph.D.
H. Westley Clark, M.D., J.D.
Constance M. Horgan, Sc.D.
Rhonda Jones-Webb, Ph.D.
Beth Kane-Davidson, LCADC, LCPC
Charles H. Lang, Ph.D.
Mary E. Larimer, Ph.D.
Laura E. Nagy, Ph.D.
Laura Elena O’Dell, Ph.D.
Scott J. Russo, Ph.D.
Edith Vioni Sullivan, Ph.D.
Katie Witkiewitz, Ph.D.

NIAAA Director and Chair: George F. Koob, Ph.D.

NIAAA Deputy Director: Patricia Powell, Ph.D.

Executive Secretary: Abraham P. Bautista, Ph.D.

Senior Staff: Vicki Buckley, M.B.A.; David Goldman, M.D.; Ralph Hingson, Sc.D.; M. Katherine Jung, Ph.D.; George Kunos, M.D., Ph.D.; Raye Litten, Ph.D.; David Lovinger, Ph.D.; Antonio Noronha, Ph.D.; and Bridget Williams-Simmons, Ph.D.

Other Attendees at the Open Session

Approximately 120 people viewed the NIH live webcast, including representatives from constituency groups, liaison organizations, NIAAA staff, and members of the general public.

Call to Order

NIAAA Director George Koob, Ph.D., called the open session of the Council meeting to order at 12:15 p.m. on Thursday, September 9, 2021. He introduced the following new members of the National Advisory Council: Nancy Barnett, Ph.D., Brown University; Andrew MacGregor Cameron, M.D., Ph.D., Johns Hopkins University; Christina Chambers, Ph.D., University of California San Diego; H. Westley Clark, M.D., J.D., Santa Clara University; Rhonda Webb-Jones, Ph.D., University of Minnesota; and Katie Witkiewitz, Ph.D., University of New Mexico. Council members and senior staff introduced themselves.

Director’s Report

Dr. Koob highlighted key recent NIAAA activities, referring to the written Director’s Report, which was distributed to Council members.

Staff Transitions: Dr. Koob welcomed Bonnie Hebb, Program Specialist, Administrative Services Branch; Nagaraja Balakathiresan, Ph.D., Program Officer, Division of Neuroscience and Behavior (DNB); Sarah Nelson, Grants Management Specialist, Grants Management Branch; and the following Post-Doctoral Visiting Fellows at the Division of Intramural Clinical and Biological Research (DICBR): Ilse Alonso, Ph.D., Laboratory for Integrative Neuroscience; and Pinaki Bhattacharjee, Ph.D., and Biswajit Kundu, Ph.D., both in the Section on Medicinal Chemistry. He also noted internal transitions of Bradley Kerridge, Ph.D., now a Program Officer in the Division of Epidemiology and Prevention Research; Andrew Kesner, Ph.D., now a Research Fellow in the Unit on Motivation and Arousal within the Laboratory for Integrative Neuroscience; and Jenica Patterson, Ph.D., now a Program Officer in the Medications Development Branch in the Division of Treatment Research (DTR). Dr. Koob also announced the retirements of Patricia Brown, former Ethics Specialist, and Patricia Chou, Ph.D., former Acting Chief of the Epidemiology and Biometry Branch, as well as the departures of Troy Zarcone, Ph.D., Science Policy Branch, and Emily Wilkins, Office of the Director, to other agencies. In addition, Dr. Koob noted the following staff departures from DICBR: Miriam Bocarsly, Ph.D., Research Fellow; Chuck Chen, Ph.D., Post-Doctoral Researcher; Lucia Guerri, Ph.D.; Yong He, Ph.D., Research Fellow; Jisoo Lee, Ph.D., Post-Doctoral Visiting Fellow; and Daniel Liput, Ph.D., Research Fellow.

FY2021 Budget: NIH received a total of $42.9 billion for FY 2021, including general increases to NIH Institutes and Centers (ICs); coronavirus supplemental appropriations; allocations for the Helping to End Addiction Long-term (HEAL) Initiative, the 21st Century Cures Act, the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, and research on influenza; and continued support for the Gabriella Miller Kids First Act pediatric research initiative. NIAAA received a total of $554.9 million for 2021. The budget for FY 2022 has not yet been finalized.

NIAAA Funding Opportunities: Dr. Koob announced the following NIAAA-issued New Notice of Funding Opportunities (NOFOs) and Notices of Special Interest (NOSIs): 
•    HIV Prevention and Alcohol (R01/R34) RFA-AA-21-016; RFA-AA-21-017

Dr. Koob also presented examples of NIH-wide NOFOs and NOSIs with NIAAA participation as follows:
•    BRAIN Initiative: New Technologies and Novel Approaches for Recording and Modulation in the Nervous System (R01) RFA-NS-21-026
•    Dyadic Interpersonal Processes and Biopsychosocial Outcomes (R01) PAR-21-280; PAR-21-281
•    American Women: Assessing Risk Epidemiologically (R01) RFA-AI-21-058
•    Notice of Special Interest: Alzheimer’s-Focused Administrative Supplements for NIH Grants that are Not Focused on Alzheimer’s Disease NOT-AG-21-018
•    Notice of Special Interest (NOSI): Social, Behavioral, and Economic Impact of COVID-19 in Underserved and Vulnerable Populations NOT-MH-21-330

A full list of NOFOs and NOSIs may be found in the NIAAA Director’s Report.

Words Matter: NIAAA Terminology Recommendations. Dr. Koob reported on NIAAA recommendations to alleviate the stigma associated with alcohol-related conditions by consistent use of non-pejorative, non-stigmatizing language to describe these concerns and the people who are affected by them. Some words that are commonly used in society, such as “alcoholic” and “alcohol abuse,” are stigmatizing. Therefore:
•    Use alcohol use disorder instead of alcohol abuse, alcohol dependence, and alcoholism
•    Use alcohol misuse instead of alcohol abuse when referring broadly to drinking in a manner that could cause harm
•    Use person-first language to describe people with alcohol-related problems (e.g., person with alcohol use disorder instead of alcoholic, person in recovery instead of recovering alcoholic)
•    Use alcohol-associated liver disease instead of alcoholic liver disease

NIAAA is changing its website to reflect these changes to terminology.

Addressing Diversity, Equity, and Inclusion (DEI) at NIAAA and in the Alcohol Research Community: Dr. Koob outlined steps that NIAAA is taking to address DEI, including: Establishing an internal NIAAA Race and Medicine Interest Group; continued recruiting of talented and diverse investigators to the NIAAA intramural workforce through the NIH Distinguished Scholars Program and the Lasker Clinical Research Scholars Program; exploring establishment of a new training program focused on networking and mentoring (inspired by the Summer Program in Neuroscience, Excellence, and Success [SPINES] model); increasing support for NIAAA’s diversity supplement program; reinvigorating and expanding the National Advisory Council Working Group on Diversity and Health Disparities in the Biomedical Workforce; establishing a steering committee to identify DEI priorities and monitor progress of new and ongoing DEI efforts; and analyzing NIAAA application and funding data to identify specific points of disparity.

Demographic Analysis of Research Project Grant Applications/Awards: As a follow-up to the DEI steps outlined above, Dr. Koob shared data about research project grant applications and awards submitted FY 2010 through FY 2020. Most applications during this period were submitted by White applicants (71 percent) and a smaller proportion of applications were submitted by Asian applicants (19 percent), Hispanic applicants (5 percent), Black/African American applicants (2 percent), and applicants identifying as two or more races (1 percent). More applications were submitted by males (58 percent) than females (39 percent).Twenty percent of applications were funded overall and males and females were equally likely to receive an award.  Award rates by race and ethnicity were: White (21 percent), Hispanic (19 percent), two or more races (19 percent), Asian (17 percent) and Black/African American (12 percent).  

Applications for fellowships and career development awards were more likely to be submitted by females (59 percent) than males (37 percent). The majority of applications were submitted by White applicants (72 percent), and a smaller proportion of applications were submitted by Asian applicants (11 percent), Hispanic applicants (7 percent), Black-African American applicants (3 percent), and applicants of two or more races (3 percent). Overall, 37 percent of these applications were awarded.  Award rates were fairly evenly distributed between men (37 percent) and women (38 percent) and across race/ethnicity groups (White, 39 percent; Black/African American, 38 percent; Asian, 36 percent; and Hispanic, 33 percent). The eventual success rate of applications for NIAAA fellowship and career development awards is high at 54 percent overall, including for female (56 percent), male (54 percent), White (58 percent), Black/African American (54 percent), Hispanic (49 percent) and Asian (49 percent) applicants.

Recent Webinars: NIAAA and the International Town and Gown Association hosted a series of webinars, “The Updated College Alcohol Intervention Matrix (CollegeAIM): What Colleges and Communities Need to Know Now,” in April, May, and August. In July, NIAAA sponsored “Innovations in Treating Stress and Trauma in Women with Alcohol Use Disorder” in which panelists discussed the link between recent increases in rates of alcohol use disorder (AUD) in women and stress and trauma.

Alcohol Research: Current Reviews (ARCR): ARCR, an open-access peer-reviewed journal published by NIAAA, released a 14-article topic series on “Recovery from AUD” this year. Co-edited by Dr. Brett Hagman (NIAAA) and Dr. John Kelly (Recovery Research Institute), the series includes articles on topics such as “What Is Recovery?”; “Sex and Gender Effects in Recovery from Alcohol Use Disorder”; “Brain Structure and Function in Recovery”; “Natural Recovery by the Liver and Other Organs After Chronic Alcohol Use”; “Racial/Ethnic Disparities in Mutual Help Group Participation for Substance Use Problems”; and “The Role of the Family in Alcohol Use Disorder Recovery for Adults.”

What’s Ahead? The 2021 NIDA-NIAAA Mini-Convention, “Frontiers in Addiction Research,” will be held virtually on November 1-2, 2021, from 11 AM-3 PM.

Research Highlights: Dr. Koob presented highlights of alcohol-related research studies: 

”Intercalated Amygdala Clusters Orchestrate a Switch in Fear State” was published in Nature (2021 Jun;594(7863):403-407. doi: 10.1038/s41586-021-03593-1. Epub 2021 May 26) by KM Hagihara, O Bukalo, M Zeller, A Aksoy-Aksel, N Karalis, A Limoges, T Rigg, T Campbell, A Mendez, C Weinholtz, M Mahn, LS Zweifel, RD Palmiter, I Ehrlich, A Lüthi, and A Holmes. Effective extinction of fear memories prevents persistent, excessive reactions to threats that are associated with anxiety or trauma-related disorders. Researchers identified two clusters of neurons in the amygdala, ventral and dorsal intercalated cell masses (ITCs), that differentially mediate the acquisition and retrieval of fear extinction memory in mice. Inhibition of the ventral ITCs impaired both extinction memory formation and retrieval, whereas inhibition of the dorsal ITCs strengthened retrieval of extinction. Investigators also demonstrated that the two clusters have direct, selective access to major cortex-amygdala loops that regulate fear extinction. Collectively, the results suggest aberrant ITC function could contribute to susceptibility to various psychiatric conditions and may have implications for understanding the neuropathological basis for post-traumatic stress disorder.

“Alcohol Use Disorder and Non-Fatal Suicide Attempt: Findings from a Swedish National Cohort Study” was published in Addiction (2021 Jun 22. doi: 10.1111/add.15621.) by AC Edwards, H Ohlsson, E Mościcki, C Crump, J Sundquist, KS Kendler, and K Sundquist. Analysis of longitudinal nationwide Swedish registry data showed that AUD was robustly associated with suicide attempt after adjusting for sociodemographic factors and psychiatric comorbidity. Sex differences (risk for suicide attempt gradually declined across age for women with AUD, while risk increased from age 15 to 29 before declining in men with AUD) and age-of-onset effects were observed, with early-onset AUD more strongly associated with suicide attempt. AUD appears to be an important predictor of suicide attempt, results that have clinical implications for screening for suicidality risk in AUD diagnosis.

“Alcohol Consumption Is Associated with Poor Prognosis in Obese Patients with COVID-19: A Mendelian Randomization Study Using UK Biobank” was published in Nutrients (2021 May 10;13(5):1592. doi: 10.3390/nu13051592) by X Fan, Z Liu, KL Poulsen, X Wu, T Miyata, S Dasarathy, DM Rotroff, and LE Nagy. Using the UK Biobank cohort, this study examined the association between alcohol consumption and odds of SARS-CoV-2 infection and risk of death, using both traditional regression analyses (of self-reported alcohol consumption data) and Mendelian randomization analyses (of relevant genetic variants as a proxy for alcohol consumption). Alcohol consumption was not associated with either increased or decreased risk of SARS-CoV-2 infection. However, in White patients with obesity, frequent alcohol consumption, especially heavy drinking, was associated with greater risk for worse COVID-19 clinical outcomes (ICU admission and death). The findings suggest that alcohol can worsen the prognosis in patients with other risk factors for dying from COVID-19, such as obesity. 

“Transcriptomics Identifies STAT3 as a Key Regulator of Hippocampal Gene Expression and Anhedonia during Withdrawal from Chronic Alcohol Exposure” was published in Translational Psychiatry (2021 May 20;11(1):298. doi: 10.1038/s41398-021-01421-8) by WY Chen, H Chen, K Hamada, E Gatta, Y Chen, H Zhang, J Drnevich, HR Krishnan, M Maienschein-Cline, DR Grayson, SC Pandey, and AW Lasek. Investigators collected hippocampal tissue from rats during withdrawal from chronic alcohol exposure. RNA sequencing followed by network analysis identified the transcription factor STAT3 gene as a central node in a cluster of genes. Stat3 was not only elevated in the rat hippocampus during withdrawal, but increased expression of pSTAT3-labeled cells was also observed in the post-mortem hippocampus of humans with AUD. Inhibition of STAT3 reversed the post-withdrawal anhedonia phenotype in rats, suggesting that STAT3 signaling in the hippocampus may contribute to negative affect associated with AUD.

“Ketogenic Diet Reduces Alcohol Withdrawal Symptoms in Humans and Alcohol Intake in Rodents” was published in Science Advances (2021 Apr 9;7(15):eabf6780. doi: 10.1126/sciadv.abf6780) by CE Wiers, LF Vendruscolo, JW van der Veen, P Manza, E Shokri-Kojori, DS Kroll, DE Feldman, KL McPherson, CL Biesecker, R Zhang, K Herman, SK Elvig, JCM Vendruscolo, SA Turner, S Yang, M Schwandt, D Tomasi, MC Cervenka, A Fink-Jensen, H Benveniste, N Diazgranados, GJ Wang, GF Koob, and ND Volkow. During alcohol withdrawal, acetate plasma levels fall, causing an energy deficient state. To test the hypothesis that a deficit in energy from acetate in the brain contributes to symptoms of alcohol withdrawal and increased alcohol drinking, investigators assessed the impact of a high-fat, low-carbohydrate “ketogenic diet” intervention, that raises brain acetate levels, in patients with AUD undergoing alcohol detoxification. Patients on the ketogenic diet needed fewer benzodiazepines to treat alcohol withdrawal and showed less alcohol craving compared with patients who consumed a standard American diet. Rats with a history of a ketogenic diet self-administered significantly less alcohol compared to those on a regular chow diet. The study provides clinical and preclinical evidence that a ketogenic diet may offer a unique AUD treatment option to alleviate withdrawal symptoms and to lower alcohol craving and consumption.

“Effectiveness of Spironolactone Dispensation in Reducing Weekly Alcohol Use: A Retrospective High-Dimensional Propensity Score-Matched Cohort Study” was published in Neuropsychopharmacology (2021 Aug 2. doi: 10.1038/s41386-021-01117-z. Epub ahead of print.) by VA Palzes, M Farokhnia, AH Kline-Simon, J Elson, S Sterling, L Leggio, C Weisner, and FW Chi. Spironolactone is a mineralocorticoid receptor (MR) antagonist that is widely used in primary and specialty care settings to treat a variety of health conditions such as essential hypertension, heart failure, primary hypoaldosteronism, hypokalemia, and nephrotic syndrome. To test the hypothesis that MRs may represent a novel pharmacological treatment for AUD, investigators conducted a pharmacoepidemiologic retrospective cohort study to examine whether dispensation of spironolactone (≥90 continuous days), for any indication, was associated with changes in weekly alcohol use about 6 months later. Findings revealed that for patients who drank more than 7 drinks/week at baseline, those treated with spironolactone (vs untreated patients) reported a reduction in weekly alcohol use by around four drinks. No significant difference was observed among patients who drank less at baseline. Spironolactone (or other MR antagonists) may hold promise as a pharmacotherapy for AUD.
 
Request for Information (RFI): NIAAA Strategic Plan Update
Bridget Williams-Simmons, Ph.D., and Rachel Anderson, Ph.D., updated Council on development of the NIAAA Strategic Plan for FY 2022-2026. Dr. Williams-Simmons identified two purposes of the strategic plan: To help NIAAA evaluate and revise its research goals and areas of interest, and to serve as a communication tool for external stakeholders. New to the current strategic planning process is the use of an NIH common template that includes an emphasis on stewardship, management, and accountability. The 2022-2026 Plan will be available exclusively as a digital product that will allow NIAAA to highlight progress in real time. NIAAA began the development process with listening sessions with staff and others, followed by meetings with each Division to solicit their input. A working group developed an outline based on these early planning activities, followed by a Request for Information (RFI) to engage stakeholders in the planning process. The working group analyzed the comments received in response to the RFI, which will inform the formal development of the document. 

Dr. Anderson, who is leading the strategic planning effort, reported on the proposed outline and comments in response to the RFI. She identified the plan’s goals and how they align with the research areas identified in the NIH-wide Strategic Plan. Specifically, these include:
•    Goal 1A: Elucidate the biological mechanisms of alcohol-related action and pathophysiology of alcohol use disorder and organ damage (Research Area 1: Foundational Science)
•    Goal 1B: Identify and track the social, environmental, and behavioral causes and consequences of alcohol misuse (Research Area 1: Foundational Science)
•    Goal 2: Prevent and reduce alcohol misuse and associated developmental effects, health conditions, and acute harms (Research Area 2: Disease Prevention and Health Promotion)
•    Goal 3: Advance diagnosis and treatment of alcohol-related conditions (Research Area 3: Treatments, Interventions, and Cures)

The working group also identified the following cross-cutting themes that impact all areas within NIAAA:
•    Health equity, diversity, and inclusion in alcohol research
•    “Whole person health” and integrated alcohol care
•    Co-occurring conditions that interact with alcohol misuse 
•    Innovation and technology to improve diagnosis, prevention, and treatment of alcohol-related conditions 
•    Individual- and population-level alcohol-related risks and outcomes across the lifespan 
•    Data science approaches in alcohol research 
•    Individual differences in diagnosis, prevention, and treatment of alcohol-related conditions to identify opportunities to advance precision medicine 
•    Collaborative science to leverage resources and to integrate alcohol topics into other health research 

The RFI invited feedback on these draft goals and themes. Seventy-one respondents provided input. Over one-half were researchers. More than 40 percent were affiliated with a substance use community organization, while about 25 percent worked as a health professional. About one-third responded as a representative of an organization, while about 18 percent identified themselves as a member of the public. Just under 10 percent shared that they had lived experience with AUD or Fetal Alcohol Syndrome Disorder (FASD).

The RFI feedback emphasized expanding access to diagnosis, prevention, and treatment of alcohol-related problems by using non-traditional community settings and other culturally relevant locations that may better serve vulnerable populations compared to traditional healthcare settings; increasing support for community-based participatory research; expanding support for health services research and implementation science to increase treatment utilization; educating health professionals; encouraging more cross-disciplinary research teams/collaboration; and supporting telehealth. In response to NIAAA’s health equity and diversity theme, respondents recommended that the Institute consider NIMHD’s research framework to guide the commitment to health equity (i.e., a holistic multilevel and multidimensional approach); increase health disparities experts in NIAAA’s workforce and study sections; and include mentorship and training support not only for underrepresented investigators, but also to those mentoring and leading training.

Dr. Anderson encouraged Council members to submit their comments on the goals and themes. Currently, a detailed outline is under development to capture revised input from the scientific division staff and consideration of the RFI responses. The stewardship, management, and accountability section is also under development, including communication and outreach/dissemination activities as well as leveraging partnerships to expand the Institute’s reach.

Discussion: Dr. Carpenter reflected on the research project application/award analysis presented earlier and encouraged NIAAA to think more broadly about its DEI process, including considering overlooked groups such as sexual gender minorities. Dr. Williams-Simmons responded that NIAAA will continue to be more inclusive in its approach, but noted that lack of data (e.g., on sexual minority applicants/awardees) could be a limitation. Elizabeth Powell, Ph.D., explained that NIH is limited by the Office of Personnel Management (OPM)’s binary classification of gender, so there is no information available on sexual orientation. Rhonda Webb-Jones, Ph.D., asked if NIAAA collected information on the type of institutions represented by applicants, e.g., how many applications are from Historically Black Colleges and Universities (HBCUs) and Hispanic-Serving Institutions (HSIs)? An analysis of institution type could be explored but NIAAA would need guidance on how to classify  appropriately individual institutions. Dr. Webb-Jones observed that the data could be useful when thinking about institutions for which application rates are low and that represent investigators from underrepresented groups. She also inquired if the cross-cutting themes proposed for the 2022-2026 strategic plan are significantly different from those that previous plans. Dr. Anderson responded that the themes are similar but that health equity and social determinants of health (SDoH) are more prominent in the 2022-2026 plan, as well as the emphasis on stewardship, management, and accountability. Dr. Koob noted that a strong emphasis in the RFI comments was a community focus; he noted that NIAAA has been heavily engaged in disseminating evidence-based information to the public. He also observed that DEI in general has been moved to a more prominent role, as well as the importance of health services research. Dr. Williams-Simmons invited Council members to look at the 2017-2021 strategic plan to identify what might be missing or needs to be emphasized. Jill Becker, Ph.D., commented that it’s challenging to obtain funding for cross-cutting research, because the Center for Scientific Review (CSR) study sections may lack experts who can assess cross-cutting themes. In response to a question from Dr. Koob, Dr. Bautista explained which grants are reviewed in-house by NIAAA and which are reviewed by CSR study sections. Beth Kane Davidson congratulated NIAAA on its efforts to promote evidence-based information and encouraged the Institute to continue to focus on dissemination to medical schools, health professionals, and the general public. Dr. Koob identified Americans’ lack of knowledge about alcohol as his greatest challenge as NIAAA Director and described key initiatives NIAAA has undertaken to inform audiences about alcohol, including the Core Resource for Health Professionals that will launch soon. H. Westley Clark, M.D., J.D., commented that, from a harm reduction perspective, it’s important to examine the issues in people’s lives that lead them to drink. He also noted that alcohol use among adolescents has declined and marijuana use remains an issue along with alcohol use in this group. Dr. Koob noted a recent news report that marijuana use has increased during the pandemic among adolescents, while alcohol use has declined. These substances have an impact on the developing brain which hasn’t fully matured until about the mid-twenties.

Council Discussion:
Edith Sullivan, Ph.D., lauded NIAAA for promoting a change in the college drinking culture by educating college students and their parents in a non-threatening way about the dangers of alcohol. Dr. Koob highlighted NIAAA’s CollegeAIM that has been distributed to every college and university to identify effective alcohol prevention interventions. Dr. Williams-Simmons reported that CollegeAIM was updated in 2019 with ten additional interventions identified via literature review for a total of about 60 interventions that colleges can use at either individual or environmental levels. She also noted that there are parent fact sheets on the NIAAA website that provide up-to-date information about college drinking. Patricia Powell, Ph.D., noted that alcohol use declined during the pandemic when college students were no longer in social settings, but changes may be expected as students return to campus. Dr. Koob asked Fred Donodeo, NIAAA, if there is a plan to revive regular radio interviews on going back to school. Mr. Donodeo responded that NIAAA’s satellite media tours have focused on themes such as Dry January during the pandemic, but the back-to-school theme should restart next year. This year, NIAAA is pitching the COVID effect on college drinking described by Dr. Powell to the media. He also noted that the Institute plans to highlight some interventions from CollegeAIM on the NIAAA website that apply to any young adult, whether in school or not. Ralph Hingson, Ph.D., interjected that these are good interventions that work with both college and non-college young people between 18 and 30. There are a lot of transitions that people experience during this period in their lives; some of these transitions (e.g., getting married, having children) may affect their drinking so the Institute is looking at how to tailor interventions to address those transitions with the goal of reducing drinking.

Council Member Presentation: “Social Influences on Alcohol Use and Health Risk Behaviors Among Young Adults: Pathways to Prevention”
Dr. Koob introduced Council member Mary Larimer, Ph.D., who presented her research about social influences (i.e., perceived norms) on alcohol use among young adults and how those norms can be influenced. She noted that young adults are at risk for excessive alcohol use, much of it occurring in social contexts. The consequences of such high levels of use include blackouts, unprotected/unplanned sex, sexual assault, impaired driving, academic/employment consequences, and physical injuries/deaths, as well as risk for developing AUD. 

Both college and community samples of young adults are at risk; there has been relatively more research with 4-year college student samples at majority-serving institutions. CollegeAIM targets the college community and is the culmination of decades of NIAAA-supported intervention research. There is not a comparable tool for use outside college settings, but there are resources in adult prevention that can be applied to young people in community settings.

Normative components are prominently featured in individual interventions that have demonstrated higher effectiveness in CollegeAIM. Normative components seek to reduce the idea that drinking is expected and normal on college campuses. These interventions have higher effectiveness because perceived norms are consistent predictors of alcohol use among young adults and align with most theories of the etiology of alcohol use and misuse in this age group. There are both descriptive norms (based on perceptions of what people do) and injunctive norms (based on what people approve of) related to drinking outcomes. Most intervention research has focused on descriptive norms, but there are also dual pathway models that include both. Norms predict drinking outcomes both concurrently and prospectively. Norms change over time and without intervention; however, norms can be influenced to impact risk reduction.

Most college students think others are engaging in alcohol use more than they actually are, and therefore feel pressured to consume more themselves to fit with the perceived norm. In Dr. Larimer’s studies, the researchers provide corrective information, i.e., that the norm is lower than the students think and even lower than their own behavior. As a consequence, students reduce drinking to conform with the new norms. Most of this research has been done at majority-serving institutions, but there is considerable evidence that these normative misperceptions are present in many communities. Recently, Dr. Larimer and her colleagues looked at norms in tribal colleges and universities (TCU). They found that most TCU students perceived other students to be drinking twice a week, consuming about seven drinks on each occasion and 15 drinks in a week. National data, however, indicated that most students drank less than once a week with an average consumption of three drinks per occasion and a total of four drinks per week. In another study, norms were found to interact with stress during life transitions. For example, Dr. Larimer’s team examined stress among those transitioning from college to employment and found that norms interact with pre-employment stress, such that those who encountered more difficulty and stress in finding a job and who perceive that employees and supervisors in a given job drink more were also more likely to increase their drinking during the transition.

There is good reason to focus on the college population. Dr. Larimer and her colleagues examined alcohol consumption among high school seniors who were transitioning to either 4- or 2-year colleges or the workforce, with a 12-month follow-up. They found a 57.6 percent increase among those at a 4-year university at follow-up; 23.5 percent among those at community college; and 18.9 percent among those who entered the workforce. Alcohol-related consequences were, as might be expected, highest among those enrolled in 4-year colleges and universities. Fortunately, however, the researchers have demonstrated that those patterns can be attenuated among high school students transitioning to college and that drinking can be reduced among the heaviest drinkers through the provision of personalized feedback that includes descriptive and injunctive norms. The researchers found that the heaviest drinkers (those consuming about 15 drinks on a single occasion) could be transitioned out of the heaviest drinking group to a lower one if they received personalized normative feedback, and that those who began in a lower group were less likely to transition into a heavier drinking group.
One question has been the extent to which interventions are appropriate for those who don’t drink for social reasons but to cope, and if it’s appropriate for those who’ve had alcohol-related harm/victimization while incapacitated. A secondary analysis of the data from two clinical trials demonstrated that, in fact, personalized normative feedback had a greater impact on the subsequent drinking behavior of individuals who had a history of incapacitated rape.

Types of Normative Feedback: Dr. Larimer and her colleagues have also studied the impact of different types of normative feedback (descriptive, injunctive, both together, and embedded within more comprehensive personalized feedback), and found that all are efficacious in reducing alcohol use and its consequences among undergraduates. Most are effective in the first three months and the effect is largely maintained over time. Descriptive and injunctive norms alone had a faster effect than when they were combined or embedded. Injunctive personalized feedback alone had a greater impact on not drinking at all in a particular week. Understanding that the amount other young adults drink is lower than one thinks may provide some “cover” for those who prefer not to drink. 

The fact that the more complex personalized feedback did not generally outperform the individual normative feedback may be a helpful finding because the single normative components scale more easily into larger interventions; on the other hand, these findings are not consistent with behavior change theory. Therefore, the researchers are currently in a trial to evaluate whether they are simply overwhelming people with the more complex intervention, which may trigger resistance among those who are not yet ready to change. They’ve learned that sequential and modular presentation of feedback, i.e., spacing different components of the message over time rather than presenting them all at once increases attention and close reading without reducing satisfaction. There is also some emerging evidence that sequential presentation of the information is more efficacious. The study is also evaluating the efficacy of text message boosters targeting high risk events, such as spring break.

Future Directions: In a current study, Dr. Larimer and her colleagues are targeting individuals who are having difficulty sleeping; about one-quarter of young adults report insomnia which may be related to their substance use. The researchers are providing normative feedback about the percentage of young adults who use cannabis or alcohol as a sleep aid. This is something that will be targeted in upcoming intervention trials. They are also trying to take advantage of the impact of norms in influencing behavior by leveraging how norms and behaviors change over time. For example, undergraduate drinking is now down, with 75 percent of college students not drinking heavily in comparison to 65 percent in 2014. Former post-doctoral fellow Scott Graupensperger, Ph.D., now at the University of Washington, has shown that people who have seen this trendline predict that drinking will continue to decrease. This impacts their intention of future drinking, beginning a “pre-conformity process” with the expected norm. People who do not see the trendline believe drinking will increase. 

Pandemic’s Impact: Dr. Larimer’s team was in the field with an intervention trial when the pandemic hit; they wondered if norms would continue to operate in the same way in the absence of most social activity on campus. They discovered that there was a subset of individuals who perceived drinking increased during the pandemic among their peers although most students accurately said it decreased; many thought it had decreased more than it actually had. They also found that these perceptions continued to have an impact on the individual’s own behavior. The researchers have also found that college students underestimate how much their peers adhere to COVID prevention guidelines. Again, their perception influenced how much they themselves adhered to the guidelines. Similar results were recorded in terms of students underestimating their peers’ intentions to receive COVID and influenza vaccinations and the misperception’s impact on their own behavior. Thus, there is room to utilize normative misperceptions to increase adherence to prevention guidelines and vaccination rates.

Discussion: Dr. Koob asked about the impact of social media on perceptions.  Dr. Larimer responded that social media may have contributed to the idea that drinking increased during the pandemic. It is easier to see examples of people drinking excessively than to see examples of people drinking less or not at all. At the same time, norms have been an important aspect of self-regulation of behavior prior to the emergence of social media. Dr. Witkiewitz welcomed the research on the impact of sleep deprivation on decision making about drinking, as the topic has mostly been ignored. She asked Dr. Larimer about the degree to which her findings are influenced by working with White college samples. Dr. Larimer replied that although most research has been conducted with White students at majority-serving institutions, there is new research being done with HSIs and TCUs that will be published soon. Laura O’Dell, Ph.D., inquired via chat about how normative misperceptions should be linked with advertising to vulnerable populations. Dr. Larimer noted that there’s an incredible body of work of research on advertising that affects young adults. Advertising strategies can be used to impact norms. Most of her research centers on individually delivered personalized feedback, which has been shown to be more effective than advertising. Dr. Webb-Jones asked in the chat: Are normative misperceptions regarding alcohol and marijuana use similar or different among college students? Dr. Larimer responded that there are misconceptions about cannabis that can be corrected with normative feedback, although her team has had more success with alcohol than with marijuana. Dr. Becker asked in the chat: To what extent have you looked at whether there are sex differences in the effect of your information about perceptions on outcomes? Dr. Larimer said there are sex differences:  Women drink less than men and perceive that other people drink less. Women are responsive to personalized information, whereas generalized feedback has been more successful with men. Ms. Davidson asked in the chat: Did you look at drink influences, e.g., hard ciders, impacting beliefs of less harmful drinking? Dr. Larimer responded that her research team collects information about what students drink, but converts that data to standardized drinks in order to measure outcomes consistently. Dr. Barnett noted that social networks influence behavior, i.e., heavy drinkers are more likely to associate with other heavy drinkers, and non-drinkers with non-drinkers. She asked how to leverage the social influences of non-drinkers on heavy drinkers. Dr. Larimer concurred with Dr. Barnett’s description of how alcohol use varies across networks. She pointed out that there are misperceptions within social networks and more variability than might be expected; non-drinkers are typically silenced within these networks. 

Council Member Presentation: “Effects of Minimum Legal Drinking Ages”
Dr. Koob introduced Council member and health economist Christopher Carpenter, Ph.D., who described his research with Carlos Dobkin, Ph.D., University of California Santa Cruz. His presentation focused on applying a regression discontinuity design to study the effects of the minimum legal drinking age on drinking patterns and their consequences. Underage drinking is estimated to cost society $53 billion annually in alcohol-related consequences such as mortality, morbidity, and crime, among others. However, it is unclear how much of the costs are truly caused by alcohol due to unobserved heterogeneity, e.g., low discount rates or individual preferences for risk. Most studies cannot distinguish these alternative explanations.

The regression discontinuity (RD) design is based on the idea that nature moves in smooth continuity, and not in discontinuous jumps. An RD design leverages sharp changes in treatments and outcomes at some predetermined threshold, despite unobservable confounders being “smooth.” Therefore, one can examine if outcomes (e.g., alcohol-related consequences) jump discontinuously at the same predetermined threshold; if so, one can have increased confidence that the outcome is due to treatment rather than to confounding variables. The researchers strongly believe these unobserved characteristics (i.e., confounding variables) are distributed smoothly across that discontinuity. For example, the full costs of accessing alcohol fall dramatically at age 21 in the United States, taking into account not only dollars but also the “hassle costs,” such as getting an older sibling or friend to procure the liquor. Two individuals who are very close in age and extremely similar in other unobservable characteristics will have sharply different costs accessing alcohol; in this case, the predetermined threshold is the legal drinking age (21). Using his own and others’ research, Dr. Carpenter demonstrated a discontinuous jump in alcohol consumption at age 21 in the United States. He then examined changes in mortality, morbidity, and crime occurring at age 21.

Mortality: Dr. Carpenter presented research on alcohol-related mortality based on the universe of death certificates in the U.S. National Vital Statistics System, 1997-2004, permitting identification of the exact dates of birth and death. The researchers used this data to plot mortality rates, asking: Over the age range of 19-23, is there a discontinuous change in mortality at 21? In fact, there is an increase in mortality in the United States at age 21 based on easier access to alcohol; nothing else changes at 21 that would provide an alternative explanation to the discontinuous jump observed in the number of deaths.

Morbidity: The discontinuous jump in mortality at age 21 due to alcohol may also be observed in morbidity patterns, based on analysis of data for emergency department (ED) visits for alcohol intoxication or related injury in three states (Arizona, New Jersey, and Wisconsin) and hospital admissions in four states (Arizona, New York, Texas, and Wisconsin) in which exact dates of birth and ED visits could be determined. Again, there is clear evidence for a discontinuous change in ED visits for injury or alcohol intoxication at age 21. Especially interesting is an examination of the causes of injury: There is a sharp discontinuous jump for deliberate injury by another person; i.e., access to alcohol increases one’s chances of being victimized. 

Crime: Some of the most stunning data comes from an analysis of arrest records in California’s Monthly Arrest and Citation Register (MACR), 1979-2006, which includes exact dates of birth and arrest (arrest and crime are not exact equivalents). The analysis reveals large discontinuous jumps at age 21 in alcohol-related arrests, including violent crime, with a huge birthday effect at ages 21 and 22. For violent crime, there is no discontinuous change for murder nor manslaughter arrest and a subtle change in rape arrests. But there is a large discontinuous change in arrests for aggravated assault (involving a weapon) and other assault (e.g., using a fist). There is also a birthday effect, suggesting that birthday drinking leads to behaviors that lead to arrest. 

There is strong internal validity in these analyses, but RD design trades off internal and external validity. Therefore, it is not possible to predict what would happen if the minimum legal drinking age were changed from 21 to other ages.

Discussion: Dr. Koob asked if there are sex differences apparent in these analyses. Dr. Carpenter responded that there are some differences, but the picture is complicated and difficult to discern. What the researchers have found consistently is that drinking age does not affect time of first drink nor lifetime use; it only predicts what happens at age 21 in terms of drinking intensity. The effects on men are high—they drink at higher intensities. Dr. Carpenter cited studies in Canada (where the drinking age is lower than in the U.S.) that show that the impact of drinking age, including on mortality, is higher for men than for women. In terms of crime, women are not arrested at high rates so there is a tricky power issue in the data analysis. Dr. Koob inquired about differential impacts of drinking age across nations. He wondered if there would be an exaggeration of the U.S. pattern in countries with younger drinking ages or an amelioration in a country with a drinking age of 25, given differences in brain development by age. Dr. Carpenter shared data from Austria where the drinking age is 16; it shows a very similar pattern of discontinuity at drinking age. He noted that more research is being conducted on this issue, and the findings vary considerably across countries. There is insufficient information to understand what influences such variability. Patricia Powell, Ph.D., inquired if differences in alcohol-related accidents at the legal drinking age in different countries reflect a difference in driving laws. Dr. Carpenter agreed that this is a possibility. Dr. Powell also noted that morbidity depicted in Dr. Carpenter’s slides declined by age 22, even though intoxication levels did not. She asked if the harms caused by drinking generally decreased. Dr. Carpenter responded that it depends on the type of adverse outcome; there is more evidence of a decline for mortality, mostly due to auto accidents, and for morbidity; there is less evidence for a decrease in violent crime. But the heart of the question is whether alcohol access is permanently changing outcomes or is displacing in time when those outcomes would happen, which might be influenced by brain development. In some outcomes, there is evidence of displacement rather than permanent change. Dr. Powell asked if there was a sense that making the drinking age later than 21 or implementing a graduated approach to a legal drinking age would be helpful. Dr. Carpenter responded that a graduated approach to getting a driver’s license has worked well in the United States and that a similar system for drinking could be a sensible alternative to current law. 

Concept Clearance: Epidemiology and Prevention of Alcohol Misuse in Understudied Young Adult Populations: Military, Workforce, Community College
Mike Hilton, Ph.D., Deputy Director, Division of Epidemiology and Prevention Research (DEPR), presented a concept clearance for a NOSI seeking research in epidemiology and prevention among young adults who are not enrolled in four-year colleges/universities. As background, Dr. Hilton explained that the age period 18 to 29 is one where several risk factors concentrate. Consequently, much research on alcohol epidemiology and prevention has focused on this age period. However, the bulk of that research has focused on four-year college students. Of 22 trials funded in the previous fiscal year, none were among young adults in the military, workforce, or community colleges. Therefore, the purpose of the proposed NOSI is to balance the NIAAA research portfolio by supporting research on the epidemiology and prevention of alcohol misuse among persons aged 18 to 29 who are not enrolled in four-year colleges or universities.

The scope of research to be considered includes adapting and validating interventions known to be efficacious in college populations to other young adult populations; testing interventions specifically developed for these groups; understanding how risk and protective factors operate among these groups; conducting trials of screening, brief intervention, and referral to treatment in these populations; studying the impact of post-traumatic stress disorder (PTSD) and combat deployment as comorbidities and risk factors; and documenting gaps in health disparities among young adult populations.

Discussion/Action: Ms. Davidson commented that she found this concept to be very exciting because there is a great need for this research. Dr. Becker suggested in the chat that the title be changed to “Epidemiology and Prevention of Alcohol Misuse in Understudied Young Adult Men and Women in the Military, the Workforce, and in Community College.” She noted that--especially in studies of the military-- women may be overlooked. Drs. Witkiewitz and Larimer expressed concern that doing so would exclude those who do not identify as gender-binary. Dr. Larimer suggested that the NOSI include language that both women and gender minorities should be included in studies; Dr. Becker concurred with this suggestion. Dr. Bautista stated that NIAAA will use NIH approved terminology regarding inclusion; no one will be excluded. Dr. Sullivan also expressed excitement with the concept, noting that research on the emerging adult population who are not in college is sparse. Dr. Hilton commented that a related unstudied issue is the moderating influences (e.g., marriage, children) on alcohol use by young adults in their late 20s and 30s; understanding these natural forces could lead to better prevention.

Action: Ms. Davidson and Constance Horgan, Ph.D., endorsed the concept, “Epidemiology and Prevention of Alcohol Misuse in Understudied Young Adult Populations: Military, Workforce, Community College.”

Concept Clearance: Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use Disorder (AUD) and Alcohol-Associated Organ Damage (AAOD)
Jenica Patterson, Ph.D., Program Officer, Medication Development Branch, DTR, presented a concept clearance that is a reissue of a Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) announcement to support development of new therapeutics to treat AUD and alcohol-associated organ damage (AAOD). 

There is an urgent need to develop new medications to treat AUD and AAOD. In the United States, approximately 14.5 million people have an AUD. Alcohol is the third-leading preventable cause of death in the United States. Alcohol misuse costs the United States $249 billion per year due to health care expenses, lost work productivity, crime, property damage, and other adverse outcomes. Only three medications (four formulations) are currently approved by the Food and Drug Administration (FDA) for the treatment of AUD; there are no FDA-approved therapies for AAOD.

The purpose of this solicitation is to provide support to small business concerns for the optimization, development, and translation of pharmaceutical research discoveries into new treatments for disorders that fall under the mission of the NIAAA (AUD and AAOD), and to advance small molecules, natural products or biologics for AUD or AAOD through the drug development pipeline towards commercialization and FDA approval. The NOFO will seek applications from small businesses that propose to advance these classes of therapeutics beyond preclinical development by preparing to seek regulatory approval for future trials. The NOFO will contain two phases: Phase 1 studies will include chemistry, manufacturing and control activities; pharmacokinetic evaluations in relevant species; safety; and optimization. Phase 2 studies will support IND-enabling activities and small early phase clinical trials, if appropriate.

Dr. Patterson concluded by noting that additional AUD pharmacotherapies are needed, including for people with co-occurring health conditions. Medication development to treat AUD and AAOD is a program priority at NIAAA as referenced in the 2017-2021 NIAAA Strategic Plan. Due to the complexity of drug development for AUD and AAOD, especially IND-enabling activities, support is needed to help bridge the gap and overcome the “valley of death” that disrupts the drug development pipeline. Through this program announcement, NIAAA will provide support to de-risk drug development and stimulate interest in the development of compounds to treat AUD and AAOD.

Discussion: Dr. Koob emphasized the need for human trials in medications development. Raye Litten, Ph.D., explained that DTR has had three medications go through this program. One has an IND and the other two are close. There was a fourth medication, but the small business sold it to a pharmaceutical firm that decided not to enter the alcohol field. Thus, the program has been successful. Dr. Clark inquired in the chat if the pharmaceutical industry is interested. Dr. Patterson responded affirmatively; Dr. Litten concurred, noting that NIAAA is working hard to get word about the program out. 

Action: Dr. Larimer endorsed the concept, “Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use Disorder (AUD) and Alcohol-Associated Organ Damage (AAOD).”

Concept Clearance: Alcohol Consumption During the Pandemic: Extending Longitudinal Survey and Analysis
Gregory Bloss, M.A., M.P.P., Contracting Officer’s Representative, DEPR, requested Council approval to allow Research Triangle International (RTI) to submit a contract proposal in response to a sole-source Request for Proposal (RFP). NIAAA is proposing a single source acquisition to RTI per FAR 6.302-1 to support extension of previous longitudinal surveys and related analyses addressing alcohol consumption trajectories during the COVID-19 pandemic and other related analyses. An RFP will be issued via beta.SAM.gov along with the NIH-approved justification and approvals for other than full and open competition. 

Under FAR 6.302-1, Government contract law allows federal agencies to award sole source contracts for supplies or services from only one source if the source has submitted an unsolicited research proposal that: a) Demonstrates a unique and innovative concept, or, demonstrates a unique capability of the source to provide the particular research services proposed; b) a concept or services not otherwise available to the Government; and c) Does not resemble the substance of a pending competitive acquisition. 

As background, Mr. Bloss explained that RTI conducted an initial survey of 993 respondents in a nationally-representative online sample during May 2020 to evaluate changes in alcohol consumption between February and April 2020. NIAAA contracted with RTI to conduct a follow-up survey of the same respondents to assess alcohol consumption and related behaviors during July and November 2020. Additional data is needed to understand changes in consumption and related behaviors as the pandemic continues to evolve, as well as analysis to understand potentially manipulable factors that may be available to prevent or reduce health risks associated with alcohol misuse.

RTI’s initial survey found significant increases in alcohol consumption early in the pandemic, both overall and among some key subgroups, including females, Blacks, and drinkers with children in the home. The re-survey conducted under contract to NIAAA found that these increases were sustained later into the pandemic period, with the largest increases observed among Black men and women, Hispanic women, people with children, and those with mental health problems who drink to cope. Compared with February 2020, consumption in November 2020 increased by 39 percent, the proportion of respondents exceeding drinking guidelines increased by 39 percent, and binge drinking increased by 30 percent.

The proposed contract will support two additional waves of data collection from the original sample of respondents surveyed by RTI in May 2020, as well as an “enriched” parallel sample that will support more detailed comparisons, identification of key contextual factors, and subgroup analyses; permit epidemiologic analysis of the survey results, including trends and patterns in consumption and related behaviors among relevant subgroups such as those defined by sex, age, race and ethnicity, family composition, and other relevant characteristics; and provide additional analyses to evaluate the role of alcohol-related policies adopted in response to the pandemic and other causal factors and correlations to identify potential points of intervention and emerging treatment needs.

Under the scope of the contract, RTI will conduct two additional survey waves with the original respondents and will recruit a new sample of 1,000 respondents to enrich the original sample and support subgroup analyses. Survey questions will include questions from previous waves as well as questions reflecting contextual developments in the pandemic, such as vaccinations and ongoing policy changes. NIAAA will direct the survey content and analyses assessing changes in alcohol consumption and the role of changing alcohol-related policies and other factors as causal determinants of changes in behaviors and alcohol- and pandemic-related outcomes.

The COVID-19 pandemic has created unique conditions with the potential to markedly increase risks associated with alcohol misuse, including stress associated with social isolation, fear of infection, economic disruptions, and loss of loved ones, that affect behaviors and attitudes that lead to changes in drinking behaviors. Disinhibition associated with intoxication and the contexts in which drinking occurs may lead to increased risks of exposure and infection with the SARS-CoV-2 virus. NIAAA has supported a range of research on alcohol and the COVID-19 pandemic, but there have been very few nationally-representative studies of changes in consumption. The RTI data are the most comprehensive that have been reported to date. The opportunity to extend the longitudinal data collection is time-sensitive and provides a basis for identifying strategies for targeting prevention and treatment interventions where they are most needed. 

Discussion: Dr. Koob stated there are several reasons to do this: 1) NIAAA didn’t know the pandemic would continue unabated; 2) The second wave of results was fairly dramatic in terms of an increase in drinking; 3) Alcohol sales are difficult to interpret because they involve both on-premise and off-premise sales; and 4) There have been changes in how alcohol is distributed in different jurisdictions, e.g., allowing alcohol to be delivered to homes or in parks and public venues. Although the research could be solicited via a grant mechanism, NIAAA would lose the cohort and contractor expertise. Dr. Webb-Jones commented that this is a great and much needed study. She asked if there were plans to oversample underrepresented groups. Mr. Bloss responded that there will be sufficient power to discern meaningful differences across groups.

Action: A majority of Council members voted in the chat to approve the sole source contract to RTI.

Consideration of Council SOP and May 11, 2021 Minutes/Future Meeting Dates    
A majority of Council members voted via chat or email to approve the Council’s Standard Operating Procedures (SOP) and the minutes of the NIAAA Advisory Council meeting held on May 11, 2021. 

Dr. Bautista announced upcoming meeting dates for 2021-2024. In 2022, Council will meet on February 10, May 10 and September 8; the CRAN meeting will be on May 11. In 2023, Council will meet on February 9, May 9, and September 7; the CRAN Council will meet on May 10. In 2024, Council will meet on February 8, May 14, and September 12; the CRAN Council meeting will meet on May 15.

Council Discussion:
Dr. Koob explained to new Council members that their job includes raising questions about individual grants in closed session and identifying areas that have been neglected in the NIAAA portfolio. He asked Dr. Powell to comment on the reinvigoration of the National Advisory Council Working Group on Diversity and Health Disparities in the Biomedical Workforce. She explained that the Working Group will examine how to provide support, e.g., mentoring, to early investigators and trainees. Many previous members have retired from Council, so NIAAA will be reaching out to current members to participate. She noted that increasing diversity is a top priority at the Institute. Dr. Koob added that mentoring needs to start as early as possible and follow people throughout their careers. Dr. Powell commented that one thing that was learned by the Working Group previously is that there are a variety of approaches to mentoring that work. Dr. Becker suggested that an NIAAA version of the SPINES program would be a great thing to do. She also commented that she is worried about assistant professors who started studies, but may not be able to write grant applications now because they can’t get their data due to the pandemic. Dr. Koob asked Council members to alert the Institute to individuals who are doing good work and get a good review score so that NIAAA can prioritize those who are in trouble. Dr. Bautista commented that Council members can look at applications and focus on the summary statement to make sure the score matches the narrative. He also suggested looking at the priority score to determine if resubmission is necessary. Dr. Witkiewitz interjected that she is worried about young investigators coming off K grants who have been limited in what they can do under COVID; they may not have pilot data to transition to an R award. Dr. Koob noted that there are two things NIAAA can do to support these young investigators. One is supplements; the other is alerting study sections where NIAAA does the reviews that people should be given the benefit of the doubt under these conditions. Dr. Bautista explained that most of the K grantees remain under the 10-year eligibility as Early Stage Investigators (ESIs). NIH has a Katz ESI R01 award program in which preliminary data are not allowed if the Principal Investigator is going to change or expand scientific direction, even to a modest degree. Dr. Koob noted that NIAAA has been funding all ESIs, including resubmissions, at the 25th percentile. NIAAA can’t change review scores but does look out for people in trouble. Dr. Barnett asked for confirmation that Council members should educate young investigators and encourage them to reach out to NIAAA Program Officers to help them navigate a system that is not well understood. Dr. Koob affirmed that young investigators should reach out for help.  He lamented the number of people who give up and never resubmit their applications when they have a “come on” score. Instead, they should be talking to the Program Officer about what could be improved in their application.

Adjournment
Dr. Koob adjourned the meeting at 4:59 p.m. 

CERTIFICATION 
I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.

George F. Koob, Ph.D.
Director, National Institute on Alcohol Abuse and Alcoholism
Chairperson, National Advisory Council on Alcohol Abuse and Alcoholism

Abraham P. Bautista, Ph.D.
Director, Office of Extramural Activities
Executive Secretary, National Advisory Council on Alcohol Abuse and Alcoholism