DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

161st Meeting of the
NATIONAL ADVISORY COUNCIL ON ALCOHOL ABUSE AND ALCOHOLISM

September 8, 2022

The National Advisory Council on Alcohol Abuse and Alcoholism (NIAAA) convened for its 161st meeting at 12:22 p.m. on Thursday, September 8, 2022, in hybrid format (i.e., both in-person and via Zoom videoconference and NIH Webcast). The Council met in closed session from 11:00 a.m. to 11:40 a.m. to review grant applications and cooperative agreements. Dr. Abraham P. 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 11:40 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.
H. Westley Clark, M.D., J.D.
Nancy Gonzales, Ph.D.
Constance M. Horgan, Sc.D.
Rhonda Jones-Webb, Ph.D.
Beth Kane-Davidson, LCADC, LCPC
David Kareken, Ph.D.
Charles H. Lang, Ph.D.
Mary E. Larimer, Ph.D.
Michael J. Lewis, Ph.D.
Laura E. Nagy, Ph.D.
Laura O’Dell, Ph.D.
Scott J. Russo, 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.; Ralph Hingson, Sc.D.; M. Katherine Jung, 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 150 people observed the meeting, including representatives from constituency groups, liaison organizations, NIAAA staff, and members of the general public.

Call to Order

NIAAA Director Dr. George F. Koob, called the open session of the Council meeting to order at 12:22 p.m. on Thursday, September 8, 2022. Dr. Koob introduced new Council members: Dr. Nancy Gonzales (Arizona State University), Dr. David Kareken (Indiana University School of Medicine), and Dr. Michael J. Lewis (Hunter College). The other Council members and NIAAA 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.

In Memoriam. Dr. Koob remembered Logan Johnson, an NIAAA post-baccalaureate Intramural Research Training Award (IRTA) fellow in the Intramural Section on Medicinal Chemistry, who passed away on June 11, 2022.

Fiscal Year (FY) 2022 Budget. NIAAA is currently closing out Fiscal Year (FY) 2022 and its FY 2022 budget totaled $554.9 million. The President’s FY 2023 budget was released on March 28, 2022, but has not been finalized.

NIAAA Funding Opportunities. Dr. Koob announced the following NIAAA-issued new Notice of Funding Opportunity (NOFO):

• Early Liver Transplantation Cohort Study for Alcohol-Associated Liver Diseases (R01, RFA-AA-22-003). This NOFO supports collaborative research projects conducted by multidisciplinary teams on early liver transplantation (ELT) for patients with alcohol-associated liver disease. The NOFO encourages observational clinical studies to examine factors that influence the criteria for patient selection for ELT and that influence post-ELT outcomes.

Dr. Koob also announced the following Notice of Special Interest (NOSI) issued by NIAAA:

• Notice of Change to NOT-AA-20-018, Notice of Special Interest: Secondary Analyses of Existing Alcohol Research Data. This NOFO encourages the utilization of data from the NIH-sponsored All of Us initiatives to conduct secondary analyses as specified in NOT-AA-20-018. It updates the previous Notice with an additional research objective to examine differences in alcohol consumption alone or in combination with other substance use, risk and protective factors, and comorbid psychiatric and/or chronic physical conditions in people who consume alcohol.

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

Advancing Diversity, Equity and Inclusion in the Alcohol Field. Dr. Koob reviewed current NIAAA-supported funding opportunities and efforts to expand health disparities research, including:

• Alcohol Health Services Research (PAR-22-156/157/158/159), encourages research on reducing health disparities as one way to address the alcohol treatment gap
• Administrative Supplements to Support All of Us and Health Disparities-Related Pilot Research Projects at NIMHD-Funded Research Centers in Minority Institutions (RCMI) (NOT-MD-22-015)
• Helping to End Addiction Long-term (HEAL) Initiative: Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies (NOT-NS-22-066)

Dr. Koob also highlighted examples of NIAAA-supported funding opportunities and efforts to enhance diversity in the alcohol research enterprise and beyond, including:

• A new Plan for Enhancing Diverse Perspectives (PEDP) requirement that is now included in Requests for Applications for Specialized Alcohol Research Centers (P50) and Comprehensive Alcohol Research Centers (P60) (RFA-AA-22-001/002)
  • Diversity supplements

NIH Loan Repayment Program (LRP). NIAAA supports the NIH LRP that was established by Congress to recruit and retain highly qualified health professionals into biomedical or biobehavioral research careers by repaying up to $50,000 annually of a researcher's qualified educational debt in return for a commitment to engage in NIH mission-relevant research. Current LRP Notices address clinical research, pediatric research, health disparities research, and research in emerging areas critical to human health. NIAAA’s priorities in the emerging areas include basic research in metabolism, health effects, and neuroscience, preclinical research in medications development, ; and research utilizing computational and data science approaches. The FY22 deadline for applications is November 17, 2022.

Closing the Alcohol Treatment Gap. Dr. Koob reviewed recent NIAAA efforts and priorities to close the treatment gap. Areas of focus include:

Recovery. September is National Recovery Month. Little is known about what sustains long-term recovery from alcohol use disorder (AUD). To advance research on this topic, NIAAA defined recovery from AUD with feedback from key recovery stakeholders as follows:

Recovery is both a process of behavioral change and an outcome that incorporates time periods for two key components: remission from DSM-5 AUD and cessation from heavy drinking (a non-abstinent recovery outcome).

The NIAAA definition also emphasizes the importance of biopsychosocial functioning and quality of life in enhancing recovery outcomes. NIAAA recently released an NOFO (PAR-22-158/159) that includes a focus on research about the risk and resiliency factors related to recovery and relapse, including the factors that allow some people to recover without receiving formal treatment.

Integrating Treatment of AUD and Alcohol-Associated Liver Disease (ALD). Deaths from ALD increased by 22 percent between 2019 and 2020. ALD has become the leading indication for liver transplantation in the United States. Treating AUD with medications reduces the chances of developing ALD and the progression of existing ALD. On July 12-13, 2022, NIAAA hosted a workshop, “Clinical Trial Design for Integrated Care for Patients with Alcohol Use Disorder and Alcohol-associated Liver Disease,” to review the status of the integrated care models for patients with ALD in clinical settings, achieve common understanding of how to address the coexistence of ALD and AUD in clinical research, and identify approaches for treating alcohol use in patients with liver disease.

Healthcare Professionals Core Resource on Alcohol (HPCR). The HPCR, developed by NIAAA, consists of 14 interconnected articles covering the basics of what every healthcare professional needs to know about alcohol. NIAAA is promoting the HPCR through social media and outreach to academic institutions, professional organizations, health plans, websites and apps for healthcare professionals, and other federal agencies.  A webinar on the HPCR is planned for November 2022.

Women’s Health. Studies suggest that women are more likely than men to experience a variety of alcohol-related harms at comparable doses. Also, women are less likely than men to receive AUD treatment. A 2017 publication showed that only 26 percent of 230 structural neuroimaging studies on substance use over 23 years evaluated sex differences, a finding that emphasizes the importance of additional research on alcohol-related sex differences. On October 20-21, 2022, NIAAA will hold a “National Conference on Alcohol and Other Substance Use in Women and Girls”. The purpose of the meeting is to identify directions for future research on harmful alcohol and other substance use among women and girls, and to highlight effective strategies that can be replicated and brought to population scale. 

What’s Ahead. “Frontiers in Addiction Research,” a virtual mini-convention presented by the National Institute on Drug Abuse (NIDA) and NIAAA, will occur on November 1-2, 2022. Scientific sessions will include: defining mechanisms that link sleep with substance and alcohol use disorder, reprogramming glia for brain recovery as a potential future substance use disorder (SUD) therapy, and understanding human neurodevelopment amid a broader social context.

Research Highlights. Dr. Koob presented highlights of alcohol-related research studies that represent the breadth of NIAAA-supported research.

“Lipoprotein Z, a Hepatotoxic Lipoprotein, Predicts Outcomes in Alcohol-associated Hepatitis” was published in Hepatology (2022 Apr; 75(4):968-982. doi: 10.1002/hep.32203. Epub 2021 Dec 7. PMID: 34662439) by K Hu et al. Lipoprotein Z (LP-Z) is an LDL-like particle found with high frequency in patients with ALD. Impaired lipoprotein metabolism in alcohol-associated hepatitis (AH) leads to the accumulation of LP-Z in the circulation, which is hepatotoxic. The investigators found that the ratio in the serum of LP-Z / total LDL, named the Z-index, could predict 90-day survival independent from the most used prognostic scoring system, Model for End-Stage Liver Disease [MELD], for disease prognosis.  This finding suggests that the Z-index might represent a new risk-stratification tool. They also found that LP-Z, at serum concentration in AH, causes direct cytotoxicity in human hepatocytes in vitro.

“Dynorphin/Kappa Activity Within the Extended Amygdala Contributes to Stress-Enhanced Alcohol Drinking in Mice” was published in Biological Psychiatry (2022 Jun 15; 91(12):1019-1028. doi: 10.1016/j.biopsych.2022.01.002. Epub 2022 Jan 10. PMID: 35190188) by HL Haun, CL Lebonville, MG Solomon, WC Griffin, MF Lopez, and HC Becker. In an animal model of combined stress and alcohol use disorder in male mice, researchers tested the hypothesis of a role of the dynorphin/kappa opioid receptor (DYN/KOR) system in stress-enhanced alcohol consumption. Forced swim stress combined with chronic intermittent ethanol exposure led to a robust and reproducible increase in alcohol consumption that was mediated by DYN/KOR activity in the extended amygdala. Forced swim stress increased prodynorphin levels in the central amygdala (CeA) and chemogenetic silencing of dynorphin expressing CeA neurons or micro-injection of a kappa antagonist into the CeA blocked the increased alcohol consumption produced by the forced swim stress and CIE. Additional research is needed to determine whether similar effects are observed in female mice.

“Targeted Epigenomic Editing Ameliorates Adult Anxiety and Excessive Drinking After Adolescent Alcohol Exposure” was published in Science Advances (2022 May 6; 8(18):eabn2748) by JP Bohnsack, H Zhang, GM Wandling, D He, EJ Kyzar, AW Lasek, and SC Pandey. Adolescent alcohol exposure in rat models produces epigenetic modifications in the synaptic activity response element (SARE) of the gene encoding the activity-regulated cytoskeleton-associated protein (Arc), leading to decreased Arc expression in the central amygdala (CeA). Decreased Arc expression, in turn, is associated with increased adult anxiety and alcohol consumption. Researchers used CRISPR/dCas9 gene editing to show that increasing histone acetylation at the Arc SARE led to reduced adult anxiety and alcohol consumption in adolescent alcohol-exposed rats while increasing histone methylation led to increased anxiety and alcohol consumption in control rats. These findings show a key molecular causal mechanism mediating the epigenetic interaction linking adolescent alcohol exposure to AUD and comorbid anxiety.

“Development and Preliminary Effectiveness of a Smartphone-based, Just-in-Time Adaptive Intervention for Adults with Alcohol Misuse Who Are Experiencing Homelessness” was published in Alcoholism: Clinical and Experimental Research (2022 Jul 23. doi: 10.1111/acer.14908. Epub ahead of print. PMID: 35869820) by ST Walters, EY Mun, Z Tan, JM Luningham, ET Hébert, JA Oliver, and MS Businelle. Adults experiencing homelessness have an eight-fold higher rates of AUD. This study investigated the development and preliminary effectiveness of a smartphone-based, just-in-time adaptive intervention to reduce alcohol use among this population using brief ecological momentary assessment. Over a 4-week period, individuals showed a decrease in alcohol use and high levels of satisfaction with the intervention.

”Constructs Derived From the Addiction Cycle Predict Alcohol Use Disorder Treatment Outcomes and Recovery” was published in Psychology of Addictive Behaviors (2022 Aug 11. doi: 10.1037/adb0000871. Epub ahead of print. PMID: 35951419) by K Witkiewitz, ER Stein, VR Votaw, KA Hallgren, BC Gibson, CL Boness, MR Pearson, and SA Maisto. A three-stage addiction cycle comprising three domains of dysfunction has been proposed as a heuristic framework for understanding AUD. This study validated the domains of the addiction cycle (incentive salience, negative emotional states, and executive function deficits) using data from Project MATCH and COMBINE, two of the largest multisite alcohol clinical trials ever conducted. The results support the utility of the domains in predicting AUD treatment outcomes and recovery. The authors noted that the addiction cycle domains were more strongly associated with outcomes than with AUD symptoms.

“Prenatal Alcohol Exposure Can Be Determined from Baby Teeth: Proof of Concept” was published in Birth Defects Research (2022 Aug 15; 114(14):797-804. doi: 10.1002/bdr2.2054. Epub 2022 Jun 10. PMID: 35686682) by AC Montag, CD Chambers, KL Jones, PS Dassanayake, SS Andra, LM Petrick, M Arora, and C Austin, Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD). In most suspected FASD cases, the strength of the diagnosis depends on evidence of prenatal alcohol exposure, which is often missing. This study developed a technology showing the presence of alcohol biomarkers in naturally shed baby teeth. Further examination of these biomarkers may allow diagnosis of FASD where documentation of prenatal alcohol exposure is otherwise unavailable.

Council Discussion: Dr. Koob asked Dr. H. Westley Clark, Council member, to comment on the study about using smartphones to communicate with individuals experiencing homelessness. Dr. Clark responded that as digital therapy approaches gain momentum, there is a need to understand how to use them with individuals experiencing homelessness as well as with those in rural areas lacking broadband internet access. Dr. Koob commented that the use of digital approaches increased during the COVID-19 pandemic and is likely here to stay. Ultimately, there will need to be an evaluation of which approaches work and which do not. Dr. Clark agreed and he noted that the Veterans Administration (VA) website provides a menu of apps, including ones for post-traumatic stress disorder, that the VA has endorsed.

Dr. Koob asked Council member Dr. David Kareken if he has seen more researchers analyzing sex differences in imaging studies. Dr. Kareken mentioned that costs associated with generating sufficient sample sizes to achieve adequate statistical power as a concern but acknowledged the importance of this research. Dr. Koob noted that it is informative to report sex differences even with small sample sizes and how his own lab at NIDA examines sexes independently in their animal studies to see if there might be differences.  Dr. Jill B. Becker commented that even if there is not a statistically significant sex difference, frequently there are differences that are worth reporting.  Also, if both sexes are not examined independently, one may miss an effect altogether because the male and female results may cancel each other.  Dr. Clark encouraged researchers to not only examine sex differences but also racial/ethnic differences in alcohol and substance use.

Council member Beth Kane-Davidson commented that she was especially excited about the research on adolescents that Dr. Koob reported, noting the importance of studying adolescents and their subsequent alcohol use patterns in adulthood. Dr. Koob commented that data is becoming available on longitudinal use of alcohol, beginning in early adolescence, from the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) and Adolescent Brain and Cognitive Development (ABCD) studies.

Regarding the study by Council member Dr. Katie Witkiewitz that tested constructs for the addiction cycle, Dr. Laura O’Dell inquired if the study’s implication is that there would be different interventions at different stages of the cycle.  She also wondered if changes imparted in adolescence might have an epigenetic effect. Dr. Witkiewitz responded that the research suggests that it may be possible to target addiction treatments based on affective domain, i.e., one treatment may be more effective for those who scored high on the reward domain, whereas a different treatment may be more effective for those who score highly on negative emotionality. This would enhance providers’ ability to tailor treatments to individuals. Dr. Koob asked Dr. Scott J. Russo, Council member, about the use of CRISPR technologies in brain studies.  Dr. Russo responded that the use of the delivery system (e.g., putting a viral vector surgically into the brain) is a challenge for the psychiatry field. There are some emerging delivery tools, e.g., focused ultrasound, that would allow for less invasive targeting.

Council Member Presentation:  Enforcement of Underage Drinking in the U.S. from 2010 to 2019

Dr. Koob introduced Council member Dr. Rhonda Jones-Webb (University of Minnesota School of Public Health) who reported on trends in enforcement of underage drinking policies based on research funded by NIAAA and conducted by the School’s Alcohol Epidemiology Program.

Background. According to the 2021 Monitoring the Future (MTF) survey, fewer American teens are consuming alcohol than ever before on all prevalence measures. However, underage drinking remains a persistent problem, and early drinking is a risk factor for AUD and other alcohol related problems. The research presented here addresses the prevalence of local law enforcement strategies aimed at underage drinking at two time points, i.e., 2010 and 2019, to determine if enforcement has changed over time. It’s important to recognize that many underage drinking policies are enacted at the local-level, and enforcement may involve several enforcement agencies whose practices and resources may vary widely. Over this decade, larger societal trends affecting police enforcement, e.g., a greater focus on community employment and the use of technology (e.g., body cameras), have occurred and could impact enforcement of underage drinking policies.

Methodology. Data for the study was drawn from the National Enforcement Survey in 2010 and 2019, based on interviews with local-level law enforcement (municipal police, county sheriff) and state-level enforcement (alcoholic beverage control and highway patrol). Stratified samples of 742 law enforcement agencies were selected from a list of municipal and county law enforcement agencies from the U.S. Department of Justice, Bureau of Statistics.  The three largest cities in each state were included in the sample. The response rates were 66 percent in 2010 and 73 percent in 2019.

Study measures included:

• Underage drinking enforcement (i.e., compliance checks for sales to underage patrons, adult provision of alcohol to underage persons, and underage possession/consumption of alcohol),
• Agency characteristics (i.e., number of officers per 1,000 population, officer assigned to alcohol enforcement, and division dedicated to alcohol), and
• Jurisdiction characteristics from the American Community Survey 2014-2018 (i.e., percent poverty, percent Hispanic, and percent Black).

Additional measures included:

• Perceptions of how common underage drinking is,
• Priority of underage drinking enforcement, and
• Collaboration with media on enforcement of underage drinking.

Data analyses used generalized logistic regression to assess changes over time, accounting for repeated measures and controlled for agency and jurisdiction characteristics.

Key Findings. Major findings included:

• The number of full-time officers per 1,000 population increased over the study period, but the likelihood of an officer who was specifically dedicated to alcohol enforcement decreased significantly.
• All three underage drinking enforcement strategies decreased over the study period. It was observed that the most striking decline was for enforcing underage possession/consumption of alcohol.
• There was also a decrease in the perception that underage drinking is common as well as a decrease in collaboration with local media on underage drinking enforcement efforts.
• The priority of alcohol enforcement and the number of agencies with an alcohol enforcement division remained constant over time.

Implications/Recommendations. Underage drinking has decreased over the past decade, but enforcement is still needed because underage drinking is a persistent problem with significant social impact. Underage drinking has continued to be a low priority for agencies compared to other enforcement areas, such as community policing, building trust with marginalized communities, and new technologies. The focus should be on making underage drinking enforcement a higher priority and targeting adults who supply alcohol to underage youth rather than underage drinkers (consistent with recommendations from the Institute of Medicine).

Ongoing and Future Studies. The Alcohol Epidemiology Program at the University of Minnesota School of Public Health is continuing work based on its 2019 study, including examination of newer enforcement strategies, e.g., body worn cameras in alcohol policy enforcement, linking policy and enforcement data to alcohol outcomes, and examining racial/ethnic differences in the effectiveness of alcohol policies in reducing alcohol use and traffic crashes

Discussion: Dr. Koob asked if the study results occurred because of changes in perceptions about the prevalence of underage drinking. Dr. Jones-Webbs responded that the greater availability of other drugs may have shaped public opinion; more importantly, social issues that have forced the police to give greater priority to other issues than underage drinking impacted the results. Dr. Russo inquired if data was available about the potential impact of more recent events, such as the COVID-19 pandemic and coverage of social justice issues in the media. Dr. Jones-Webb explained that the study’s data covers a time period during which several Black men died at the hands of police, but the study did not include questions that directly addressed this issue. A follow-up qualitative study might shed light on that question. Dr. Kareken asked if data about the density of crime was collected and, if so, did it have an impact? Dr. Jones-Webb responded that the study did not collect such data, but that it is an area for future exploration. Dr. Koob concluded the discussion by noting that this study is important work in an area that is greatly underexplored.

Council Member Presentation: Changing the Rules in Transplantation: Separating Science from Stigma

Dr. Koob introduced Council member Dr. Andrew Cameron (The Johns Hopkins School of Medicine) who presented research on the status of liver transplantation, particularly among patients who are severely ill with alcohol-associated hepatitis (AH).

Background. The short-term mortality rate for severe AH is high, with a short-term mortality often higher than 50 percent and even higher for those who do not respond to steroids. A liver transplant is an option for such patients, but currently all 150 liver transplant centers in the United States require six months of sobriety before they will perform a liver transplant. The proposed rationale behind the waiting period is that it will select for patients with AUD who are likely to abstain following a transplant and exclude patients who might improve and not require a liver transplant.  Dr. Cameron asserted that this rule is arbitrary and an unreliable predictor of relapse.  Instead, it reflects stigma. Further, the six-month rule is unrealistic for patients with severe AH as 75 to 90 percent of them will most likely die within two months of diagnosis. The United Network for Organ Sharing has never adopted the six-month wait period as a policy, but it is practiced at all U.S. transplant centers.

A 2011 New England Journal of Medicine (NJEM) on early liver transplantation (ELT) to 26 patients with severe AH in France. Of the 26, about 80 percent survived at least six months following the transplant, a high rate of survival compared to a cohort of matched patients who received standard care and no transplant, nearly all whom died during the six-month study period. Patients receiving the ELT reported a 12 percent relapse rate of alcohol use. Changes in liver transplant practice followed in Europe.

ELT Pilot Program. In response to the NJEM article, Johns Hopkins (JHU) initiated an ELT pilot program in 2012. Outcomes of patients who received ELT (no six-month waiting period) would be compared to patients who received standard liver transplantation (SLT) six month waiting period).  Criteria for acceptance into the liver transplantation program were:

1. Severe alcoholic hepatitis (Discriminant Function ≥32) as first liver-decompensation (i.e. patient not aware of liver disease prior);
2. Failure of medical management, guided by Lille Score >0.45, continuous increase in MELD, or consensus by fellow, transplant surgeon, and medical hepatologist;
3. Commitment to lifelong adherence to alcohol abstinence, evaluated by substance abuse specialist, with rigorous assessment and classification of alcohol history and dependency;
4. Strong social support by family and friends, evaluated by transplant social worker;
5. Rigorous assessment of possible risk factors for alcohol relapse, by substance abuse specialist and social worker;
6. Absence of severe comorbid medical issues, evaluated by hepatologists, transplant surgeon, and other medical specialists when appropriate;
7. If there is history of psychiatric disease, patients are evaluated by transplant psychologist, with required assessment of stable psychiatric disease; and
8. Full consensus agreement by transplant committee, comprised of social worker, hepatologist, transplant surgeon.

The sample size was 88 patients in the ELT group and 75 patients in the SLT group.  Participants in the study were predominately white and male.  The ELT patients were:

• Younger (median age, 49.7 years old) than those in the SLT group (median age, 54.6 years old),
• Had a median MELD score of 36 (indicative of critically serious disease), compared to 24 in the standard care group, and
• Reported an average of 10 years of heavy drinking with pre-transplant abstinence measured in days or weeks, compared to 20 years of heavy drinking with abstinence measured in months or years in the standard care group.

Key Findings. The results were published in JAMA Surgery in 2021.  At one-year post-transplant:

• 94 percent of the ELT patients survived, compared to 96 percent of the SLT group.
• 20 percent of the ELT group had relapsed to any alcohol use, compared to 20 percent of the SLT group.

Ongoing Research. JHU has established a Specialized Alcohol Research Center at JHU (DELTA Center), where investigators will continue to study the existing ELT cohort carefully, in addition to enrolling new ELT and standard care cohorts for evaluation, transplantation, and provision of post-transplant care, including medical and behavioral follow-up. In addition, new projects at the Center will address:

• optimization of post-transplant care via biomarkers and behavioral interventions;
• proteomic analysis of explanted livers with characterization of autoantigens; and
• animal transplant models to characterize immune and regenerative effects of alcohol.

JHU explants and biobanks liver tissue from transplant patients, making it available to researchers interested in studying ALD.

ELT During the Pandemic.  Dr. Cameron noted that in 2020, liver transplantations at JHU stopped for anyone who could wait due to the pandemic; however, JHU continued to receive critically ill patients with severe AH in need of ELT and at higher numbers. 

Discussion. Dr. Koob asked Dr. Cameron if the abstinence rate would improve if there was a standard protocol for state-of-the-art AUD treatment with ELT. Dr. Cameron agreed that it could, noting that the liver transplant community typically does not address AUD post-treatment for patients. If they have good liver function, transplant providers may assume that their patients are not drinking. There is a need to implement modern treatment strategies to prevent relapse in the transplant arena. Not only would that greatly improve outcomes, but it would also increase confidence among other transplant centers that they could do ELT with successful outcomes.  Guidelines on patient selection and best standard post-transplant care at the national level is needed.  Dr. Kathy Jung, Director, Division of Metabolism and Health Effects, NIAAA, identified the need to have multi-site studies among transplant centers that provide geographic and patient demographic diversity with similar but not identical standard operating procedures to provide the evidence to inform national liver transplant guidelines. Dr. Cameron concurred that multicenter observational studies and dissemination of findings are what the field needs.

Dr. Clark commented that he was struck by the number of white patients in the pilot program. He asked if JHU is making an effort to ensure that minority patients have access to liver transplants. Dr. Cameron replied that Hopkins serves a city that is 60 percent African American. The transplant program strives to apply strategies for its innovative procedures in a way that is equitable and fair. In the patient cohort of transplants, more than 80 percent are White. This is disconcerting and an area of active study at JHU. The demographics of the ELT group is not statistically different from that of the SLT group. He noted that patients referred to JHU for evaluation for a liver transplant have been referred by a primary care provider. They also need to have health insurance and a good social support network, which is subject to the perception of providers. This may be where the loss of diversity occurs in terms of patients who receive transplants.

Dr. Laura Nagy, Council member, asked Dr. Cameron if the recidivism rate in the French group compared to the JHU cohort may be related to the emphasis in the French study on the patient’s family and social support. She also inquired if the behavioral modifications or counseling between the ELT and SLT groups was the same or more intensive in the ELT group. Dr. Cameron responded that JHU considers the patient’s social support network as an important criterion. Therapies (pharmacology and cognitive behavioral therapy) to prevent relapse are offered to all patients, not just those in the ELT cohort.

Dr. Constance M. Horgan, Council member, asked if the individuals in the pilot program who achieve sobriety were in treatment and/or on medication. Dr. Cameron responded that the six-month sobriety status is based on self-report. He noted that the strong emphasis on sobriety as a criterion for liver transplant encourages patients to not be forthcoming about alcohol use. Instead, treatment and support should be provided to all patients to help them achieve sobriety.

Homelessness and Alcohol Use Disorder (AUD)

Dr. Koob introduced Dr. Mariela Shirley and Dr. Diedra Roach, both of the Division of Treatment and Recovery, NIAAA, who updated Council on NIAAA priorities and activities regarding individuals experiencing homelessness and AUD.

General Scope of Homelessness. Dr. Shirley began with an overview of homelessness, highlighting findings from the U.S. Department of Housing and Urban Development’s (HUD) 2020 Annual Homeless Assessment Report (AHAR) to Congress:

• 580,466 people were homeless during the 2020 Point-in-Time count, representing a 2.2 percent increase over 2019. This marks the fourth consecutive annual increase in homelessness, following sustained reductions between 2010 and 2016.
• Approximately 65 percent of those experiencing homelessness are found in homeless shelters, and the other 35 percent are found unsheltered on the street.
• The majority is age 24 or older.
• Six out of ten are male.
• Almost one-half (48.3 percent) are White.
• The most striking disparity can be found among African Americans, who represent 13 percent of the general population but account for 39 percent of people experiencing homelessness and more than 50 percent of homeless families with children. This imbalance has not improved over time.

Causes of homelessness. Homelessness occurs when housing is out of reach, there is a disparity between income and housing costs, when an individual is escaping violence or experiencing a health crisis or disabling condition, and as a reflection of racial disparities.

Homelessness and AUD. In the general US population, the prevalence of AUD is 5.3 percent; among those experiencing homelessness, the prevalence of AUD is estimated at 40 percent. Individuals experiencing homelessness with AUD are more likely to:

• Die of alcohol-attributable causes than the general population,
• Have high rates of polysubstance use,
• Be disproportionately affected by crime, violence, and incarceration, and
• Have a disproportionately high utilization of publicly funded services, such as the criminal justice system and emergency healthcare systems. Approximately one-third visit the emergency department (ED) every year. Alcohol intoxication is cited as the most common reason for ED visits.

Barriers to AUD treatment. Barriers to accessing AUD treatment for people experiencing homelessness include:

• Lack of stable housing,
• Fractured social networks,
• Dense network of high numbers of peers with AUD or SUD for men,
• High rates of co-occurring disorders, and
• Structural and economic limitations in the healthcare system (e.g., long waitlists, cost, lack of insurance coverage, and transportation problems).

Intervention approaches. Harm reduction approaches are viewed favorably by people experiencing homelessness and AUD, as well as by providers serving this population. Harm reduction approaches include:

• Community-level interventions, such as Housing First—where immediate, permanent, low-barrier, non-abstinence-based housing is provided,
• Harm reduction treatment for alcohol (HaRT-A) —a client-driven harm reduction approach emphasizing any movement toward improved quality of life and reducing harm; and
• Managed Alcohol Programs—programs that prescribe and medically supervise alcohol use in the context of housing or emergency shelter.

In general, harm reduction approaches have decreased contacts with the criminal justice system and decreased use of emergency and safety-net health care systems among individuals experiencing homelessness. Other promising interventions include:

• Motivational interviewing, which may be insufficient as a stand-alone treatment in homeless populations,
• Contingency management strategies that may promote initiation of abstinence, and
• Adjunctive pharmacotherapy that may initiate and prolong abstinence or reductions in alcohol use.

NIH portfolio targeting homelessness. Between 2012-2022, NIH funded over 200 awards targeting homelessness across multiple Institutes/Centers (ICs). The majority of awards were funded by NIDA (66 awards), the National Institute of Mental Health (43 awards), NIAAA (20 awards), and the National Institute on Minority Health and Health Disparities (18 awards).

Selected active NIAAA awards on homelessness and AUD interventions. Between 2019-2022, NIAAA

funded nine awards for a total investment of $9,537, 947. There are very few investigators working in this research space with many of them largely responsible for repeat awards.

Dr. Shirley reviewed a grant (described above in the Research Highlights in the Director’s Report) for Development and Testing of a Just-in-Time Adaptive Smart Phone Intervention to Reduce Drinking among Homeless Adults in the Division of Epidemiology and Prevention Research. Dr. Roach described additional NIAAA awards on homelessness and AUD research in the Division of Treatment and Recovery, including:

Life-Enhancing Alcohol Management Program (LEAP) (University of Washington) targeted Individuals with prior experience of chronic homelessness and AUD in Housing First Programs. Preliminary results show that participation in two or more meaningful activities (e.g., arts, public speaking) reduced the quantity of alcohol consumed per occasion and alcohol-related harm activities, but no significant difference in alcohol outcomes.

Phosphatidylethanol (PEth)-Based Contingency Management to Reduce Alcohol Use and Improve Housing (Washington State University) is a feasibility study to determine if PEth can be used as basis for a contingency management (CM) intervention to reduce alcohol use and improve housing tenure. Preliminary findings suggest it is highly feasible in a population of housed, formerly individuals who experienced homelessness and had AUD. Individuals randomized to CM were more likely to submit PEth negative samples.

A Therapeutic Workplace for Homeless Adults with AUD (Johns Hopkins University) provided a therapeutic workplace using employment services and abstinence-contingent wage supplements. A comparison of the therapeutic workplace participant group with a control group of research participants at six months showed a significant increase in alcohol abstinence and higher rates of employment.

Brief Group MI Intervention for Alcohol and Other Drug (AOD) and Sexual Risk Behavior in Homeless Youth (RAND Corporation) evaluated AWARE, a voluntary group-based motivational interviewing program to reduce substance use and sexual risk behaviors among individuals ages 18-25 experiencing homelessness. Twelve months post-intervention, AWARE participants were more likely than controls to demonstrate significant decreases in past month drinking frequency, heavy drinking frequency, and alcohol consequences.  AWARE participants also had small reductions in symptoms of depression, quality of social relationships, and physical health as well as significant increases in the use of protective behavioral strategies related to drinking. No changes were observed for alcohol resistance self-efficacy or maximum number of drinks per day.

Future Directions. Questions to be addressed in future research include:

• What are alternative solutions to address AUD and homelessness?
• How are other social determinants of health and cultural factors considered and addressed in treatment?
• How can structural interventions (e.g., housing vouchers, housing policies) be integrated with individual approaches?

Rigorous randomized clinical trial designs are needed that elucidate:

• How, why, when, and for whom do interventions work,
• The intervention effect on the course of AUD recovery and other health outcomes,
• How interventions are designed to engage and sustain persons experiencing homeless who have concomitant AUDs,
• Ideal and/or desirable outcomes for interventions, and
• What works to extend treatment effects to promote longer-term recovery.

Other research opportunities include:

• Programs/interventions for youth that can be expanded in range and quality,
• Dissemination and implementation studies,
• The use of meta-analytic approaches to identify psychosocial and structural barriers to AUD treatment access, and
• Longitudinal studies to assess durability of intervention effects.

Discussion. Dr. Koob observed that a community reinforcement approach appears to be the most promising strategy because a successful alcohol intervention depends on a successful housing and job creation process. Dr. Shirley agreed, noting that some applications, e.g., Housing First, are proposing a community-based participatory research strategy. Dr. Mary E. Larimer, Council member, confirmed that based on her experience working with a group at the University of Washington, Housing First is using a community participatory research strategy. Dr. Clark noted that programs such as Housing First face very complex issues, including recidivism and the availability of housing. This is especially in urban areas where the housing stock is limited. Persuading neighborhoods to allow people who are actively using substances is more problematic than Housing First suggests. He recommended focusing not just on Housing First, but on the full spectrum of housing strategies and AUD strategies. He encouraged NIAAA to diversify its portfolio and to continue to work with the U.S. Department of Housing and Urban Development and the Substance Abuse and Mental Health Services Administration (SAMHSA) to address the homeless population. Dr. Roach responded that his points were well-taken and duly noted.

Concept Clearance. Model Continuums of Care Initiative (MCCI) to Advance Health Equity Among Women and Girls in Racial/Ethnic Minority and Other Marginalized Communities

Dr. Koob reintroduced Dr. Roach who presented a concept clearance for the Model Continuums of Care Initiative (MCCI) to advance health equity among women and girls in racial/ethnic minority and other marginalized communities. MCCI is a multi-IC implementation and dissemination science initiative to significantly reduce the prevalence and impact of multimorbidity among historically marginalized women of reproductive age and to improve access for subgroups of women with the least access to high quality health care (e.g., those with an SUD and/or serious mental illness or other mental health disorder, women with disabilities, etc.)

Background. Data reveal recent increases in mental health- and substance use-related problems for women and girls.  For example:

• There was a 30 percent increase in the number of adolescents with major depressive episodes between 2005-2014, coupled with a similar trend for suicide among adolescent girls and young women.
• Between 1999 -2017, a 260 percent increase in the death rate from drug overdose in women was observed.
• There was a 62 percent increase in the number of alcohol-related emergency department visits across all age groups between 2006-2014. In every age group, the rate increased significantly faster for women than for men.

There is also a burgeoning literature on the connection between depression and cardiovascular disease (CVD):

• Women experience twice the risk of comorbidity of major depressive disorder (MDD) and CVD.
• Women with a longer history/more severe MDD show a three-fold increase in risk for CVD-related clinical events and death.
• CVD comorbidity is highest in women with a history of trauma, severe mental illness, or chronic misuse of alcohol, cigarettes, or psychostimulants.
• Between 2013-2018, there was a 25 percent increase in heart disease-related deaths in women aged 18-44.

Scope of Work. The MCCI calls for community-engaged research to increase the adoption of an integrated set of evidence-based practices across the continuum of women’s health care to:

• Strengthen state and community public health surveillance system infrastructure and capacity,
• Promote provider education/training in the implementation of evidence-based practices to prevent/treat multimorbidity in women and girls,
• Integrate and coordinate primary healthcare, behavioral health systems, and community-based services to meet the health and social needs of racial/ethnic minority and other underserved women of reproductive age via a suite of coordinated studies,
• Accelerate the adoption and implementation of evidence-based screening and interventions for common comorbidities affecting women of reproductive age in high priority communities, and
• Leverage existing federal, state and local resources and collaborations for aligning community and clinical services.

MCCI Timeframe and Milestones. Short-term outcomes for the first two years (2025-2027) under the U34 funding mechanism include:

• Establishing a public-private scientific partnership involving the public health leadership in selected communities, NIH and other Federal agencies, and identifying and addressing facilitators of and barriers to the implementation of evidence-based interventions for mental health and common co-occurring disorders in marginalized communities,
• Completion of a community service needs assessment to identify strengths and key areas for improvement in the existing continuum(s) of prevention services, primary and specialty health care, reproductive health, and mental health and substance use services, and
• Enhancement of health infrastructure and research capacity, including strategies to address health policy and financing needs, data collection, integration, and harmonization needs, workforce development needs, etc.

Intermediate outcomes for years 2 to 3 (2026-2028), also under the U34 mechanism, include:

• Developing an implementation research agenda based on outcomes of community needs assessment, including input from both academic and community partners, and
• Completion of a pilot implementation study.

Long-term outcomes for Years 4 – 9 (2028-2033) under a U54 or U19 funding mechanism require:

• Large-scale implementation studies to accelerate translation of evidence-based interventions to community practice, and
• Dissemination of findings through participating community partnerships, with each partnering community serving as the “hub” for a regional learning community.

General Guidance. Type 1, 2, and 3 hybrid implementation trials (i.e., evaluation of a combination of effectiveness and implementation outcomes, or a combination of implementation and clinical outcomes) will be considered responsive while preclinical and efficacy studies will be deemed non-responsive.

MCCI Outcomes. The following outcomes are anticipated:

• Bringing evidence-based, integrative interventions for mental health and substance use disorders and common co-occurring physical conditions (e.g., hypertension; diabetes; HIV/AIDS, etc.) to population scale across the entire continuum of women’s health care (i.e., via a suite of 5 – 7 linked studies per community),
• Using a whole systems approach to optimize coordination of care,
• Catalyzing significant improvements in the health of women of reproductive age, and
• Improving maternal health and birth outcomes among women most severely affected by health disparities. 

In short, MCCI is anticipated to have a transformative impact on women’s health care.

Questions and Comments from Council Members. Dr. Nancy Barnett, Council member, asked if an application that focuses solely on girls prior to reproductive age would be considered responsive. Dr. Roach responded that MCCI focuses solely on girls and women of reproductive age. This is consistent with the program’s intent to align the initiative’s goals with ongoing public health efforts to reduce maternal morbidity and mortality among U.S. women. Dr. Christina Chambers, Council member, commented that she supports the MCCI concept which is extremely needed and provides a forward-thinking strategy to the current disjointed approach to intervention. Dr. O’Dell commented she strongly endorses this concept, particularly because it focuses on minoritized women. 

Discussion. Dr. Roach shared a written comment from Dr. Karaken stating there are critically important issues that cut across the proposal but are unstated. For example, social capital, intergenerational poverty, and low formal education are issues that would be important to quantify and assess. Dr. Kareken elaborated, noting that these are factors that could modify how one approaches the local situation and that moderate the nature of the systems that are put in place. Dr. Roach agreed, commenting that she is concerned about what can be done in the face of massive social and economic problems that beset communities with health disparities. MCCI hopes to shore up public health surveillance to capture factors that are usually not addressed in health surveys. The hope is that a women’s health report card will come out of this effort that will capture these ignored factors across the nation on a timely basis. There is currently no standard health report card for women. The goal is also to build strong partnerships with agencies that address some of these determinants of health. That’s why the scope of work emphasizes the need to build such partnerships in the first three years before any further investments are made. Dr. Clark recommended that NIAAA present the concept to SAMHSA, the Centers for Medicare and Medicaid Services, and the Health Resources and Services Administration, as part of its effort to build partnerships. Dr. Roach responded that NIAAA has been planning to pursue partnerships with these agencies but wanted to get feedback from Council before doing so. Dr. O’Dell asked Dr. Roach to comment on the intersection of age and sex in the target population. Dr. Roach responded that the initiative wants to focus on adolescent girls to prevent co-occurring conditions before they take hold. Because MCCI will focus on girls and women of color, it will be seeking partnerships with African American communities and agencies that are active with young people in those communities, as well as with Hispanic and Native American communities. Dr. Kareken asked if there are similar societal trends occurring in other industrialized nations. Dr. Koob responded that the U.S. has one of the worst maternal morbidity and mortality (MMM) rates in the world. Dr. Roach commented that outcomes are very different, depending on the community.  In poor communities, women forego prenatal care because they can’t afford it, contributing to poor MMM outcomes. The goal of MCCI is to reveal these issues and change the course of health care to improve women’s health outcomes.

Action. Dr. Witkiewitz and Dr. O’Dell endorsed the concept.

Concept Clearance. Alcohol and Other Substance Use Research Education Programs for Health Professionals

Dr. Koob introduced Dr. Laura Kwako, Division of Treatment and Recovery, NIAAA, who presented a concept clearance on Alcohol and Other Substance Use Research Education Programs for Health Professionals that would be supported by both NIAAA and NIDA. The concept falls under the NIH Research Education Program (R25) that supports research education activities in the mission areas of NIH. Thus, the overarching goal of this concept is to support educational activities that foster a better understanding of biomedical, behavioral, and clinical research on alcohol and other substance use disorders.

Background. This concept clearance is for a reissue of PAR-19-207, Alcohol and Other Substance Use Research Programs for Health Professionals (R25 Clinical Trial Not Allowed). NIAAA received 11 unique applications to PAR-19-207, of which one was funded (R25AA028203, Bringing Alcohol and Other Drug Research to Primary Care/Principal Investigators). NIDA received 23 unique applications to PAR-19-207, of which none were funded.

Scope of Work. This NOFO will support creative educational activities with a primary focus on outreach.

Supported projects will be designed to engage practicing health care professionals in education about current and emerging knowledge. Areas of interest include biomedicine, neurobiology, epidemiology, prevention, and/or treatment of alcohol and other substance use disorders.

Eligible participants. Healthcare professionals, including licensed/credentialed health care providers, therapists, and allied professionals who provide direct patient care, are eligible to apply.

Plan for Enhancing Diverse Perspectives (PEDP). Applications must include a PEDP that includes research teams richly diverse in perspectives, backgrounds, and academic disciplines, diverse in research questions informed by patient and family perspectives, and widely applicable benefits of the research. Evaluation of the applicant’s PEDP will be made during the peer review as part of the scorable criteria and during programmatic reviews.

Outcomes and Justification. The intractable public health impact of alcohol, opioids, and other substances, their associated consequences, and the persistent stigma associated with these substances is the rationale for the proposed concept. It is imperative that healthcare professionals possess the latest knowledge about alcohol and other substance use disorders and strategies for addressing them during patient interactions.

Discussion. Dr. Koob inquired about what would be new with this reissue of the PAR that could encourage more applications. Dr. Kwako responded that NIAAA and NIDA can assist applicants by clarifying all parts of the application. Points of clarification include the emphasis on the PEDP, balancing feasibility and implementation, taking into consideration the methods of delivery of the outreach materials, and program evaluation and sustainability. Dr. Jones-Webb suggested that expanding the concept to include a patient-related component may help increase the application pool. Dr. Kwako commented that a patient-oriented intervention might be included in the concept as currently written, e.g., developing more engaging patient education materials or addressing how to refer patients. Dr. Bautista noted that NIAAA previously could not include patients because the PAR language did not include them, but now it can be revised to be more inclusive. He encouraged Council members to share their recommendations. Dr. Clark wondered if the number of successful applications was low because review panels have expectations that exceed what the clinical practice community can deliver. He also suggested including nurse practitioners and physician assistants among those eligible to apply. Dr. Nancy Gonzales, Council member, asked if most applications are likely to come from the practice community or from joint academic and clinical teams. Dr. Kwako responded that most previous applications were submitted by academics or practicing health professionals embedded within academic settings. However, some came from the clinical practice community without academic ties so they may have been unaccustomed to writing applications to NIH and these applications may have been less successful. Dr. Koob asked Council members to disseminate information about this opportunity, noting that project officers are happy to help people understand how to apply for a grant.

Action. Dr. Witkiewitz endorsed the concept and Dr. Russo seconded her endorsement.

Concept Clearance. Cross-Cutting Translational Research on the Interaction of HIV and Alcohol

Dr. Koob introduced Dr. Kendall Bryant, Director, Alcohol and HIV Research Program, NIAAA, who presented a concept for basic research that is aligned with the National HIV/AIDS Strategy and its federal implementation plan. The purpose of this research initiative is to encourage mechanistic studies that explore alcohol’s effects on the gut-liver-brain axis and other organ interactions and their pathological consequences among HIV/AIDS patients that can be translated into interventions.

Background. The NIH Strategic Plan for HIV and HIV-Related Research (FY 2021-2025) identified the importance of basic behavioral and biological research that can be translated into interventions. Basic research provides the underpinning for HIV science in all prevention and treatment areas. It also may identify gaps and emerging areas where additional work can improve the understanding of how HIV is transmitted and persists in the context of alcohol use.  This work could have direct impact on translation to interventions. Among the topics identified in the cross-cutting research priority area in the NIH Strategic Plan is the influence that an individual’s microbiota has on HIV treatment.

Scope of Work. Two objectives comprise the scope of the proposed research:

1. Identify pathophysiological alterations in the gut-liver-brain axis in the development of liver/organ disease and cognitive impairment in people living with HIV/AIDS (PLWH) with multiple patterns of alcohol drinking, and
2. Determine relevant biomarkers for diagnosis and therapeutic targets for prevention/treatment of HIV/alcohol-associated liver/organ disease and pathogenic sequelae resulting in increased frailty and mortality.

For both, responsive applications will utilize a systems biology approach and integrate data from functional metagenomics, metabolomics, gut barrier dysfunction, and immunological alterations.

Outcomes and Justification. The following outcomes are anticipated:

1. Collecting data from cross-sectional and longitudinal cohorts, and investigating the relationship among functional metagenomics of the gut microbiome, metabolomics, gut barrier dysfunction, and systemic and mucosal immunological alterations and markers of liver/organ disease and injury related to brain and cognitive functioning (advancing data science),
2. Determining the effects of gut microbial dysbiosis on fecal and serum metabolites, intestinal barrier dysfunction, mucosal immune dysfunction and HIV latency, gut and systemic inflammatory changes, and
3. Developing and testing intervention strategies and approaches, including repurposing U.S. Food and Drug Administration (FDA)-approved medications in proof-of-principle models that could mitigate some intermediate outcome measures, e.g., metabolic and inflammatory conditions associated with HIV/alcohol interactions.

Responsive Applications. Research that is not interdisciplinary and directly relevant to basic cross-cutting priorities outlined under the NIH Strategic Plan for HIV and HIV-Related Research for FY 2021-2025 would be unresponsive.

Discussion. Dr. Russo commented that the focus of the concept is from a bottom-up perspective, i.e., how does alcohol work with critical systems to impact brain/cognitive function? There is good research that suggests it works the other way, i.e., that brain circuits that are responsive to alcohol and stress can interact through a complex network of peripheral nerves that innervate other organ systems. For example, recent research has shown that sympathetic innervation of the gut can directly regulate the complexity of the microbiota that can ultimately lead to alterations in the immune environment and systemic inflammation. Dr. Bryant responded that both perspectives would be included in the funding opportunity. NIH is striving to understand how best to undertake this research, given its complexity and the use of a systems biology approach. Dr. Russo noted that crafting the right language about the specific interaction of the brain to the gut and back again will be important.

Dr. Koob asked Dr. Bryant to identify three bullets of evidence that are driving this concept clearance, e.g., HIV affects the microbiome and HIV affects the immune system which also affects the microbiome. Dr. Bryant agreed and noted that there is also some evidence that the distribution of the viral reservoir is impacted by alcohol, contributing to inflammatory responses, and research on gut-brain connections. Dr. Koob noted that the concept dovetails with some of the NIH Blueprint for Neuroscience programs on interoception. Dr. Antonio B. Noronha, Director, Division of Neuroscience and Behavior, NIAAA, noted that the BRAIN Initiative is having a meeting on this topic on September 29, 2022.  

Action. Dr. Witkiewitz and Dr. Russo endorsed the concept.

Council Discussion/Public Comments

Dr. Koob encouraged Council members to share their ideas about NIAAA priorities and activities with him or with NIAAA Deputy Director Dr. Patricia Powell.

Dr. Russo, noting that he serves on the Researching COVID to Enhance Recovery (RECOVER) Initiative’s neuropsychiatric advisory committee, asked what role alcohol may play in long COVID, given the increase in alcohol consumption during the pandemic.  Dr. Jung stated that this is an important issue that has not yet been fully included in RECOVER’s research program.  Examples of questions include does alcohol consumption during the acute stage of the disease play a part in long COVID and what is the impact of alcohol consumption during the start of long COVID.  Dr. Jung asked Dr. Russo to raise these questions with the advisory committee. Dr. Koob interjected that it only takes three minutes to administer the Alcohol Use Disorders Identification Test (AUDIT-C). Dr. Raye Litten, Director, Division of Treatment and Recovery, NIAAA, explained that the AUDIT-C contains three questions related to frequency of drinking, amount of daily drinking, and number of heavy drinking days. At Dr. Koob’s request, he agreed to send a copy of the instrument to Dr. Russo.

Dr. Koob encouraged Council members to be ambassadors for NIAAA within their professional communities by letting people know that NIAAA exists and offers a website with resources such as the Alcohol Treatment Navigator, Healthcare Professional’s Core Resource (HPCR), and Rethinking Drinking. He also noted that there are three medications to treat AUD that have been approved by the FDA, as well as effective behavioral approaches such as cognitive behavioral therapy, motivational interviewing, and contingency management.

Consideration of Council Standard Operating Procedure, May 10 & 11 Council Meeting Minutes, and Future Meeting Dates

A majority of Council members voted via chat or email to approve the Standard Operating Procedures (SOP), minutes of the NIAAA Advisory Council meeting held on May 10, 2022 and the Collaborative Research on Addiction at NIH (CRAN) meeting held on May 11, 2022.

Dr. Bautista announced upcoming Council meeting dates for 2023-2025. In 2023, the Council will meet on February 9, May 9, and September 7.  The CRAN Joint Advisory Council will meet on May 10. In 2024, Council will meet on February 8, May 7, and September 12.  The CRAN Council will meet on May 8. In 2025, Council will meet on February 6, May 6, and September 11.  The CRAN Council will meet on May 7.

Adjournment

Dr. Koob adjourned the meeting at 5:02 p.m.

CERTIFICATION

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