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

159th Meeting of the
NATIONAL ADVISORY COUNCIL ON ALCOHOL ABUSE AND ALCOHOLISM

February 10, 2022

The National Advisory Council on Alcohol Abuse and Alcoholism (NIAAA) convened for its 159th meeting at 12:45 p.m. on Thursday, February 10, 2022, via Zoom videoconference and NIH Webcast. The Council met in closed session from 11:00 a.m. to 11:30 a.m. for a presentation of the NIAAA Board of Scientific Counselors (AABSC) Report, and from 11:30 a.m.-12:32 p.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 12:32 p.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.
Westley Clark, M.D., J.D.
Constance M. Horgan, Sc.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.

Ex-Officio Members

Col. Charles S. Milliken, M.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.; Antonio Noronha, Ph.D.; Aaron White, Ph.D., and Bridget Williams-Simmons, Ph.D. 

Other Attendees at the Open Session
Approximately 100 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 12:45 p.m. on Thursday, February 10, 2022. He announced the retirement of Council member Edith Sullivan, Ph.D., and thanked her for her longstanding service. 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 reported the deaths of two noted scientists: Richard Saitz, M.D., M.P.H., who made significant contributions to the alcohol prevention and treatment field, and John Spitzer, M.D., whose legacy includes the Louisiana State University Health Sciences Center (LSUHSC) Comprehensive Alcohol Research Center and the LSUHSC Alcohol and Drug Abuse Center of Excellence.

Dr. Koob welcomed the following new NIAAA staffers: Candice England and Drennan Lindsay, NIAAA Office of the Director; Dr. Muhammad Arif and Dr. Szabolcs Dvoracsko, Division of Intramural Clinical and Biological Research; and Post-Baccalaureate Intramural Research Training Award (IRTA) Fellows Madeline Behee, Zev Jarret, Logan Johnson, Carlos Melendez, Josephine Nimely, Victoria Offenberg, Ana Oliverio, Jinpyo Seo, Rodrigo Sandon Veliz, Nina Westcott, and Eli Winkler. He also announced the departure of Jamie Greuber and the retirements of Deborah Adams and James Loewke.

FY2021 Budget: The Federal government continues to operate under a continuing resolution as the Fiscal Year 2022 budget has not yet been finalized.

NIAAA Funding Opportunities: Dr. Koob announced the following NIAAA-issued New Notice of Funding Opportunities (NOFOs):

• Collaborative Partnership between Research Centers in Minority Institutions (RCMI) and Alcohol Research Centers (U54, RFA-AA-21-015): This announcement invites U54 applications for the planning and implementation of collaborative partnerships between Research Centers in Minority Institutions (RCMI) and institutions with extensive alcohol research programs, including NIAAA-funded alcohol research centers and consortia.
• Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use Disorder and Alcohol-Associated Organ Damage (U43/U44, PAR-22-102; UT1/UT2, PAR-22-103): This funding opportunity offers support to small businesses for the optimization, development, and translation of pharmaceutical research discoveries into new treatments for disorders that fall under the mission of NIAAA.

Dr. Koob encouraged investigators to talk to the scientific contacts listed in each of these announcements before developing an application to assure responsiveness.

Dr. Koob also announced the following Notices issued by NIAAA:

• Notice of Special Interest (NOSI): Epidemiology and Prevention of Alcohol Misuse in Understudied Young Adult Populations; Military, Workforce, and Community College: NOT-AA-22-001
• Notice of Special Interest (NOSI): Administrative Supplements and Urgent Competitive Revisions on Coronavirus Disease 2019 (COVID-19) within the Mission of NIAAA: NOT-AA-22-002
• Request for Information (RFI): Unhealthy Alcohol Use in Active-Duty Military: NOT-AA-21-042

Finally, he highlighted the availability of Administrative Supplements to Recognize Excellence in Diversity, Equity, Inclusion, and Accessibility (DEIA) Mentorship (NOT-OD-22-057):

• This administrative supplement recognizes the crucial role great mentors play in the development of future leaders in the scientific research enterprise. Supplements will support existing awards of scientists who are engaged in outstanding mentorship with compelling commitments and contributions to enhancing diversity, equity, inclusion, and accessibility (DEIA) in the biomedical sciences.
• Awarded supplements will provide up to $250,000.00 (direct costs; not to exceed the cost of the parent award), to grants supporting faculty members who have mentoring and/or mentorship as part of their existing awards and have demonstrated a commitment to outstanding mentorship and training, especially to individuals from groups identified as underrepresented in the biomedical sciences.
• Bautista is the NIAAA point of contact for these supplements and should be consulted prior to development of an application.

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

Summary of the Early Research on Mental Health During the COVID-19 Pandemic. Mental health has declined in both the U.S. and across the world since the pandemic began. A research team examining the impact of COVID on global mental health examined data from 204 countries and found significant increases in anxiety disorders and major depression during the pandemic, particularly for women and younger people. Another study reported an increase in the percentage of U.S. adults (18+) with symptoms of anxiety or depression and in the percentage of people who received counseling or medication for mental health conditions after the pandemic began. In a meta-analysis, researchers analyzed data from 29 studies measuring symptoms of anxiety and depression in people 18 and under during the pandemic. They reported the prevalence of clinical symptoms was 25.2 percent for depression and 20.5 percent for anxiety. Findings suggested one in four youth globally are experiencing clinically elevated depression symptoms, while one in five are experiencing elevated anxiety symptoms during the pandemic. These estimates are double the pre-pandemic estimates. Estimates were higher in studies conducted later in the pandemic, suggesting that the problem continues to worsen.

Summary of the Early Research on Drinking during the COVID-19 Pandemic. Researchers are still learning how the COVID pandemic is impacting alcohol use, but studies have shown that some people are drinking more while others are drinking less. Higher levels of stress related to distance learning, family-related issues, financial issues, and being confined to the home were associated with drinking more often and more heavily in one analysis. In several studies, increases in drinking were more likely for women, particularly those reporting increases in stress. Factors most consistently associated with increases in drinking included: Income loss/financial stress; greater depression or anxiety; greater general psychological distress; and greater drinking to cope with stress.

Determinants of Health That May Influence Alcohol Misuse and Health Equity: Social determinants of health (SDOH) include broad aspects of social and physical environments that impact quality of life and health outcomes, such as educational opportunities, housing, discrimination, and job security. SDOH can influence the likelihood of developing and recovering from alcohol use disorder (AUD), contribute to alcohol-related health disparities, and impose additional burdens on brain systems involved in stress and emotion regulation, thus increasing vulnerability for AUD.

Some examples of NIAAA-supported research on SDOH and alcohol misuse include a study that explored the link between discrimination, heavy drinking, and mental health in Latinx communities. It found that participants who engaged in heavy drinking reported feelings of exclusion that led to symptoms of anxiety and depression that, in turn, led to drinking to cope. Another study examined the relationship between adverse childhood experiences (ACEs), racial microaggressions, and alcohol misuse in emerging adults (ages 21-25) who reported heavy drinking two or more times in the past month. It found that experiencing more ACEs was associated with higher alcohol consumption and more negative consequences of alcohol misuse. For Black young adults, racial microaggressions were also associated with more negative consequences of alcohol misuse.

Improving Health Disparities in Alcohol Health Services.  SDOH contribute to health disparities. NIAAA seeks to improve health disparities in alcohol health services. Examples of current NIAAA health services research projects to address health disparities include one that is assessing the effectiveness of a culturally adapted, personalized feedback intervention among Latinx individuals with alcohol misuse and anxiety within community-based health clinics. Another study is exploring the impact of various combinations of follow-up engagement after alcohol-related hospitalization and assessing alcohol-related outcomes across racial and ethnic groups, including analysis of SDOH. A third study is examining barriers to AUD care by surveying Medicaid health plan policies related to delivery and management of AUD treatment and their relationship with access to and outcomes of care for racial/ethnic minorities, women, and rural Americans.

Defining Recovery from AUD: An NIAAA team, led by Brett T. Hagman, Ph.D., sought to define recovery operationally in order to assist researchers. The new NIAAA research definition will appear in an article in the American Journal of Psychiatry (in press). The article presents the newly developed NIAAA definition of recovery from AUD based on feedback from key recovery stakeholders (e.g., researchers, clinicians, and recovery specialists). The operational definition can be used by diverse stakeholders to increase consistency in recovery measurement, stimulate research to better understand recovery, and facilitate the process of recovery.

In the NIAAA definition, recovery is viewed as both a process of behavioral change and an outcome that incorporates two key components: 1) remission from DSM-5 AUD and 2) cessation from heavy drinking (a non-abstinent recovery outcome). It also emphasizes the importance of biopsychosocial functioning and quality of life in enhancing recovery outcomes.

New Resource: “Short Takes” Video Series to Enhance Understanding about Alcohol Terms. NIAAA recently released a video series called "Short Takes with NIAAA," a collection of brief 60-second videos that explain commonly used–but often misunderstood–alcohol terms. The first installment includes videos on: alcohol use disorder; blackouts; alcohol overdose (in Spanish and English); and binge drinking. The videos are expected to be helpful to both the general public and health care providers. Dr. Koob encouraged Council members to propose other alcohol-related terms that are likely to be misunderstood.

Research Highlights: Dr. Koob presented highlights of alcohol-related research studies suggested by NIAAA divisions and the intramural program:

“Epigenome-Wide Association Study of Alcohol Consumption in N = 8161 Individuals and Relevance to Alcohol Use Disorder Pathophysiology: Identification of the Cystine/Glutamate Transporter SLC7A11 as a Top Target” was published in Molecular Psychiatry (2021 Dec 2. doi: 10.1038/s41380-021-01378-6.) by FW Lohoff, TK Clarke, ZA Kaminsky, RM Walker, ML Bermingham, J Jung, SW Morris, D Rosoff, A Campbell, M Barbu, K Charlet, M Adams, J Lee, DM Howard, EM O'Connell, H Whalley, DJ Porteous, AM McIntosh, and KL Evans. Chronic heavy alcohol consumption is strongly associated with alterations in DNA methylation, a process that influences gene transcription. Identification of alcohol-associated methylome variation might provide novel insights into pathophysiology and innovative treatment targets for AUD. Using the largest epigenome-wide association study of alcohol consumption to date (N=8161), investigators identified 2504 methylation sites and five leading gene targets—including SLC7A11, a cystine/glutamate transporter. Biological validation and follow-up studies confirmed a substantial role for SLC7A11 in AUD. Given the prominent function of glutamate signaling in brain and liver, the results identify SLC7A11 as a novel target for therapeutic intervention in AUD.

“Development and Validation of a Postnatal Risk Score that Identifies Children with Prenatal Alcohol Exposure” was published in Alcoholism: Clinical and Experimental Research (2021 Nov 21. doi: 10.1111/acer.14749) by GA Bernes, NS Courchesne-Krak, MT Hyland, MT Villodas, CD Coles, JA Kable, PA May, WO Kalberg, ER Sowell, JR Wozniak, KL Jones, EP Riley, and SN Mattson SN, CIFASD. Investigators developed and validated an efficient and easily calculable risk score to identify an individual's risk of having been exposed to alcohol prenatally. Unlike previously published clinical tools for fetal alcohol spectrum disorder (FASD) assessment, the proposed risk score relies on measures that can be easily obtained, comprising physical measures (dysmorphology) as well as parent-reported measures of adaptive functioning and behavior for a total score of 0 – 5. With preliminary testing, the risk score shows promise in distinguishing alcohol-exposed children from control subjects, while correlating with cognitive outcomes. Importantly, the risk score could be easily deployed in a clinical setting as an early screening tool for FASD.

“Resting Hypoconnectivity of Theoretically Defined Addiction Networks during Early Abstinence Predicts Subsequent Relapse in Alcohol Use Disorder” was published in Cerebral Cortex (2021 Oct 20:bhab374. doi:10.1093/cercor/bhab374) by J Camchong, AF Haynos, T Hendrickson, MB Fiecas, CS Gilmore, BA Mueller, MG Kushner, and KO Lim. This study investigated resting-state functional connectivity in brain networks related to three addiction domains (incentive salience, negative emotionality, and executive functioning) during early abstinence in predicting relapse in alcohol use disorder. Compared to individuals who remained abstinent, those who relapsed had lower functional connectivity during early abstinence in all three brain networks, which predicted subsequent relapse. The brain networks also predicted time to relapse, whereas clinical self-reports were not reliable predictors. The findings highlight the value of functional brain connectivity as a biomarker of vulnerability for relapse and the potential of modulating functional connectivity in addiction networks as a treatment for AUD. 

“Quantifying COVID-19's Impact on Telemedicine Utilization” was published in the Interactive Journal of Medical Research (2021 Sep 6. doi: 10.2196/29880) by EL Vogt, BM Welch, BE Bunnell, JF Barrera, SR Paige, M Owens, P Coffey, N Diazgranados, and D Goldman. COVID-19 pandemic era restrictions regarding in-person care led to widespread adoption of telemedicine-based healthcare. To investigate trends in telemedicine utilization over the course of the pandemic, researchers analyzed data from doxy.me (the largest free telemedicine platform) and the NIH Clinical Center. Analysis revealed that, nationally, use of telemedicine peaked in April 2020 at 291 million minutes, stabilizing at 200-220 million monthly minutes from May to November 2020. State-level data also revealed a correlation between states with early expansion of telemedicine capacity (i.e., New England and Mid-Atlantic states) and greater overall telemedicine expansion during the pandemic. Results paint a picture of how telemedicine has evolved throughout the pandemic.

“Integrative Data Analysis of Self-Efficacy in 4 Clinical Trials for Alcohol Use Disorder” was published in Alcoholism: Clinical and Experimental Research (2021 Nov; 45(11):2347-2356) by ES Kruger, KN Serier, RA Pfund, JR McKay, and K Witkiewitz. Self-efficacy--an individual’s belief in his/her ability to organize and execute behaviors to achieve a desired outcome, such as abstinence or a reduction in heavy drinking--has been proposed as a key predictor of alcohol treatment outcomes and a potential mechanism of success in achieving abstinence or drinking reductions following alcohol treatment. The present study examined the effect of treatment on self-efficacy across four different treatment studies. All active treatments, including cognitive-behavioral treatment (CBT), medication management (MM), 12-step facilitation (TSF), motivation enhancement treatment (MET), relapse prevention (RP), and telephone continuing care (TEL), were associated with significant increases in self-efficacy from baseline to posttreatment that were maintained for up to a year. Treatment as usual in community settings, which consisted of weekly group therapy that included addiction counseling and 12-step recovery support, was not associated with significant increases in self-efficacy.

“Trends in Cannabis Involvement and Risk of Alcohol Involvement in Motor Vehicle Crash Fatalities in the United States, 2000‒2018” was published in the American Journal of Public Health (2021 Nov; 111(11):1976-1985) by MC Lira, TC Heeren, M Buczek, JG Blanchett, R Smart, RL Pacula, and TS Naimi. From 2000 to 2018, alcohol was consistently involved in approximately 40 percent of motor vehicle crash fatalities. During this time, cannabis involvement and cannabis and alcohol co-involvement in fatal motor vehicle crashes increased nationally. Fatalities involving any cannabis more than doubled from 9 percent to 21.5 percent, and fatalities involving both cannabis and alcohol more than doubled from 4.8 percent to 10.3 percent. More motor vehicle fatalities involved a combination of cannabis and alcohol (at any blood alcohol concentration [BAC] level) than cannabis alone.

A History Lesson: The Story of Margaret Mann. Dr. Koob highlighted the contribution of Margaret Mann, “a brilliant strategist and a public-relations genius who played a crucial role in mid-century alcoholism advocacy” (Washington Post, January 9, 2022) by developing a campaign that convinced the world that alcohol use disorder was not a moral failure but a medical condition.

Council Discussion: In the chat, Col. Charles S. Milliken, M.D. inquired about the definition of heavy drinking in the NIAAA definition of recovery. Rachel Anderson, Ph.D., NIAAA, responded that “cessation from heavy drinking is defined as drinking no more than 14 standard drinks per week or 4 drinks on a single day for men and no more than 7 drinks per week or 3 drinks on a single day for women.”

Dr. Koob observed that here has been an increased attention to reducing the stigma surrounding addiction, especially via the terminology used. Some people have suggested that the Institute’s title—the National Institute on Alcohol Abuse and Alcoholism—is itself stigmatizing. He noted that a change in the Institute’s title requires an Act of Congress. Such a change was first put forward in 2007 by Congressman Patrick Kennedy and Senator Joe Biden but did not pass. In June 2021, Congressman David Trone introduced a Stop Stigma Act to change the names of NIAAA, the National Institute on Drug Abuse (NIDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA). There has been no vote on this bill to date. NIAAA supports changing the name and prefers to  keep the acronym NIAAA that is an integral part of the Institute’s brand. H. Westley Clark, M.D., J.D., M.P.H., commented that as NIAAA pursues a name change, it should avoid a previous proposal suggesting that NIAAA and NIDA merge. Dr. Koob responded that there is no intention of moving in that direction. Alcohol has a unique role in society and a unique toxicology; it continues to be a huge burden on the healthcare system. NIAAA is also the largest funder of alcohol research in the world. Therefore, he feels strongly that NIAAA should remain a separate Institute because of its unique and important mission. It will continue to collaborate with NIDA through the Collaborative Research on Addiction at NIH (CRAN) and with other ICs, such as the National Center on Complementary and Integrative Health which is interested in partnering with NIAAA on issues such as pain and addiction.

Dr. Koob asked Bridget Williams-Simmons, Ph.D., to update Council on the NIAAA Strategic Plan development. She responded that NIAAA issued a Request for Information (RFI) and received feedback that has been analyzed. Her office is currently talking to the divisions and intramural program and expects to have a draft Plan to share with Council in the near future.

Dr. Koob encouraged Council members to be ambassadors on NIAAA’s behalf, especially to early career investigators; research has shown that young researchers have lost two years of their research timelines and are very stressed. NIAAA is doing everything it can to help them. Scott Russo, Ph.D., commented that many K99 awardees are trying to obtain extensions of their awards. He asked how NIAAA was handling this. Dr. Bautista responded that NIAAA is reviewing K99 extension applications on a case-by-case basis; there is a plan to issue a Notice on this topic that will be sent to Council members. Subsequently in the chat, he shared information about an NIH Notice (February 4, 2022) on further continuation of temporary extension of eligibility for the NIH K99/R00 during COVID and asked Council members to refer potential applicants to contact him for questions about NIAAA. Laura O’Dell, Ph.D., commented that young investigators need opportunities for creative collaboration and partnerships that lead to publications and shared resources. She asked how NIAAA could facilitate such opportunities. Dr. Koob responded that these investigators should contact their program officers. He also stated that NIAAA could provide opportunities to the extramural community to learn about research techniques such as those used in the Laboratory on Integrative Neuroscience (LIN); NIAAA’s intramural community should be a resource for the entire NIAAA community. David Lovinger, Ph.D., head of LIN and NIAAA Acting Scientific Director, agreed. He noted that his staff are available to serve as consultants or collaborators on grants, provided there are no legal restrictions. He encouraged researchers to reach out to his laboratory for help or collaboration.

In the chat, Mary Larimer, Ph.D., asked how NIAAA is handling second no-cost extensions (NCE) requests in light of the pandemic-related delays?” Dr. Bautista responded that NIAAA will consider all no-cost extensions as long as the allotted funds are still available; NIAAA cannot provide additional funds. Requests are handled on a case-by-case basis. Dr. Larimer clarified that if investigators need supplemental funds, they should apply for them prior to requesting their first NCE. Dr. Bautista concurred, noting that a third NCE could be problematic. The first NCE requires institutional approval; the second requires IC approval. Nancy Barnett, Ph.D., commented in the chat that the issue of 2nd NCEs is causing anxiety about the possibility they would be denied. Dr. Koob commented that the second NCE simply requires approval by NIAAA, and he sees no reason why it would not be approved. Dr. Barnett said that issues have come up with early career faculty on their first R01 grant who wonder if they should stop collecting data when their timeline calls for 18 months of data collection, but they only have a year remaining on the grant. Her advice has been to assume that an extension will be approved if all has been going well. She worries that investigators are sabotaging their research by not applying for an NCE. Drs. Koob and Bautista assured her that this is good advice, as NIAAA has not rejected a second NCE as long as the necessary funds allocated to the grant remained.

Dr. Larimer also asked if there has been any discussion given to modifying the funding caps on certain mechanisms (e.g., R01s, R21s) to allow for current inflationary pressures on staff salaries to be addressed. Dr. Koob responded that there has not yet been discussion of this issue at the IC level. Dr. Bautista concurred, noting that an applicant can submit a budget over $500,000 for an R01 with IC approval, i.e., there is not a hard cap. There are also no inflationary increases in the out-years; it is better to submit a flat budget across all years.

Cannabis and Alcohol Effects on Sleep

Dr. Koob introduced Dr. David Lovinger, Ph.D., NIAAA Laboratory for Integrative Neuroscience (LIN), that studies how brain circuits contribute to substance use disorders (SUDs). The Laboratory primarily conducts research using mouse models. LIN is studying the impact of drugs on sleep because most, if not all, psychiatric disorders have sleep pathology comorbidities. The connection between them is apparent but it is difficult to tease out which came first, the disorder or the sleep disturbance.

Cannabis and Sleep: Cannabis (marijuana) is the most widely used illicit drug. Chronic cannabis use can lead to cannabis use disorder (CUD). Sleep disruption is one of the most common reasons for both cannabis use and relapse. Efforts toward legalization of marijuana often stress its potential therapeutic effect on sleep.

THC ([-]-trans-delta-9-tetrahydrocannabinol) is the main psychotropic phytocannabinoid in cannabis and is responsible for both the development of CUD and withdrawal symptoms. THC produces effects via partial agonism of the cannabinoid type 1 (CB1) receptor. The CB1 receptor is activated by the endocannabinoids N-arachidonoyl ethanolamine (anandamide, AEA) and 2-arachidonoyl glycerol (2-AG). It is found in almost all regions of the brain. There are a robust set of pharmacological tools to look at the CB1 receptor, including potent agonists and inverse agonists/antagonists.

Despite popular claims to the contrary (e.g., “Cannabis for Sleep Comfort Month”), there is very little animal model research to substantiate the positive role of cannabis in sleep. Animal studies initiated by Matthew Pava, Ph.D., a former postdoctoral fellow at LIN, and continued by former IRTA postdoctoral fellow Karina Abrahao, Ph.D., revealed that in rodents, acute CB1 activation and increases in endocannabinoid (eCB) levels are hypnogenic, promoting stabilized non-REM (rapid eye movement) sleep. In addition, CB1 antagonism fragments non-rapid eye movement (NREM) sleep, indicating a role for eCBs in sleep stability. When cannabis is consumed, it may interfere with this natural process.

LIN scientists wanted to follow up on these finding by developing a murine model of THC withdrawal effects on sleep. Two types of murine models have been developed to study THC withdrawal: spontaneous or precipitated. In the spontaneous model, THC is administered for 6-7 days and then stopped. This results in mild withdrawal symptoms that are mostly somatic. In the precipitated model, THC is administered in a similar fashion, then the mice are given a CB1 inverse agonist. This results in reliable and stronger withdrawal symptoms that are both somatic and behavioral. The LIN researchers adopted the spontaneous model because it more closely mirrored the human experience of cannabis withdrawal.

The murine model of spontaneous THC withdrawal developed by Drs. Pava, Abrahao, and NIH Independent Research Scholar Andrew Kesner, Ph.D., is characterized by a period of acclimatization and habituation, a pretreatment period in which baseline measurements are taken, a 1-day administration of vehicle to all mice, a 6-day treatment phase in which treatment animals receive THC and control animals receive a vehicle, and then an early (days 1-2) and late (days 5-6) abstinence phase following termination of the THC during which withdrawal symptoms are observed. The THC dosage for the treatment animals is 10 mg/kg which is administered intraperitoneally.

In these studies, polysomnography is used to measure arousal states in the mice; Dr. Pava developed a fully automated scoring system to assign vigilance states which enabled more mice to be monitored. Both male and female mice are included in the studies. The investigators found that acute THC administration increases NREM sleep and that tolerance to the acute hypnogenic effects of the drug develops after chronic exposure; similar findings were reported for both male and female mice. There was decreased NREM sleep in male mice during both early and late abstinence, but not in females. Further, there were no sleep changes in either sex during abstinence after a single 10mg/kg THC injection, consistent with the tolerance paradigm, or after chronic treatment with 1mg/kg THC.

Alcohol and Sleep. Research on humans has demonstrated that acute alcohol exposure enhances sleep, while chronic exposure/drinking disrupts sleep. There have been many animal studies on alcohol withdrawal and sleep disruptions in rats; one mouse model study (Veatch, 2006) showed four cycles of chronic intermittent ethanol exposure (CIE) led to decreased NREM sleep 72 hours into withdrawal.

LIN researchers wanted to follow up on this study since they had been using the CIE paradigm. First, however, they studied acute high-dose ethanol exposure on sleep, finding that a high-dose ethyl alcohol (EtOH) injection induced an odd brain state with a characteristic oscillation in the Theta band. This suggested that a high dose of alcohol may put a person in a state that is not quite sleep and not quite anesthesia. Increased duration of NREM sleep bouts and increased number of REM sleep bouts, especially at the highest EtOH dose, were also observed.

In LIN’s current studies of the effects of chronic alcohol exposure on sleep led by Visiting Postdoctoral Fellow Pamela Alonso, Ph.D., the model consists of a 6-day baseline period, followed by four cycles of CIE (16 hours exposure per day for 4 days followed by 3 days off) using alcohol vapor with a target blood EtOH concentration >100 mg/dL, followed by 6 days of abstinence. There is not yet much data on NREM sleep. However, what was observed in Dr. Pava’s earlier studies was an increase in sleep spindles during the acute withdrawal phase. These are faster, high-amplitude signals seen in the cortex intermittently during sleep; they are thought to be a reflection of cortical activation and may have something to do with cortical function and cognition. The investigators also observed that endocannabinoids and the CB1 receptors appear to regulate these sleep spindles. The CB1 receptor blockade reduced the number of sleep spindles when CB1 inverse agonist AM281 was injected; the CB1 full agonist CP 47,497 produced the opposite effect. These findings suggested that endocannabinoids and endocannabinoid and cannabinoid drugs might affect sleep spindles and led to the question if endocannabinoids might regulate the augmentation of sleep spindles following CIE. Dr. Pava set up an experiment to examine what happened when the inverse agonist AM281 was administered during withdrawal. He found that when AM281 was injected into the animals at baseline, there is the decrease in NREM sleep spindles that was previously observed. But when AM281 is administered during withdrawal when there is normally an increase in the number of sleep spindles, the increase in both number and frequency was prevented.

Under the leadership of Dr. Kesner, LIN scientists are delving deeper into the role of endocannabinoids and CB1 receptors in chronic EtOH and chronic THC exposure. They know that sleep spindles are influenced by thalamic inputs to cortical neurons through the thalamic-cortical relay system that plays a major role in sleep and in vigilance. There are very few CB1 receptors in the thalamus itself, but there are many in the reticular neurons. In the future, LIN plans on combining a number of technologies, including genetic (e.g., CB1 knockouts), electrophysiological, fiber photometry, imaging and chemo/optogenetic manipulation to examine molecular/cellular/circuit roles in sleep and related behaviors. There are also many other brain regions to probe in future studies to learn how to overcome the deleterious effects of alcohol and marijuana on sleep. There is heavy overlap between the brain circuitry involved in sleep control and those involved in the reaction to different drugs that need to be explored.

Discussion: Dr. Koob asked Dr. Lovinger if he suspected there might be a synergistic effect on sleep from a combination of cannabis and alcohol. Dr. Lovinger responded affirmatively, noting there would be a synergistic, if not additive, effect on enhancing NREM sleep when alcohol is consumed with marijuana that would lead to reduced vigilance and motor control. He also asked Dr. Lovinger if the endocannabinoid effects observed were activity-dependent. Dr. Lovinger replied that the neuron activity is the driver. It can be activated by pain and stress that would have a whole-body activating effect, but as the individual becomes less active and falls asleep, the neurons in circuits like the thalamic-cortical system are becoming more active and generating more endocannabinoids. Dr. Russo inquired about the sex differences observed in the LIN studies, specifically what protects females? Dr. Lovinger replied that the researchers don’t yet know. There are sleep differences in male and female mice at baseline so there might be some aspects to the circuitry such that the effects observed are not strong enough to overcome sex differences. The scientists have observed differences in goal-directed behavior, attention, and the bottle-brush test that measures irritability; females seem more resilient on all these measures. Thus, there may be differential stress responses in the two sexes that they can follow up. Dr. Koob stated that NIAAA would be happy to share the automated polysomnography system developed by Dr. Pava with the field. He also noted that there are many sex differences in neurology. Jill Becker, Ph.D., commented that there are sex differences in both the endocannabinoid receptor system and in sleep patterns, making this a fascinating area of research.

Council Member Presentation: Substance Abuse Contingency Management--The Conundrums of Implementation: Moving from Research to Practice.

Dr. Koob introduced Council member Dr. H. Westley Clark, who began his presentation by noting his “conflicts of interest” on this topic: He is an Advisor to the State of California Department of Health Care Services for the implementation of the California CMS Drug MediCal Contingency Management Pilot, and a member of the Motivational Incentive Policy Group which advocates for the adoption of Contingency Management at the federal and state level.

Dr. Clark provided an overview of the prevalence of substance use in society, e.g., 7.5 million people misused stimulants in 2019 (2019 National Survey on Drug Use and Health). Of the 93,000 drug overdose deaths in 2020, 44,000 involved stimulants. Black Americans and other minorities are at higher risk for death by overdose. Between 2007 and 2019, the rate of Black Americans dying from opioids and cocaine climbed by 575 percent, compared to 184 percent among white people. While mortality from methamphetamine and other stimulants remained at lower levels in 2019 than cocaine/opioid mortality, it has increased dramatically in recent years among Black Americans. Methamphetamine and other stimulants/opioid mortality rose 16,200 percent in Black people versus 3,200 percent in white people. Cocaine/opioid overdose mortality also rose sharply among Hispanic and Asian Americans.

Currently, there are no medications approved by the U.S. Food and Drug Administration (FDA) for treating individuals with stimulant use disorder. There are three behavioral treatments for individuals with stimulant use disorder with robust empirical evidence of effectiveness: Contingency Management (CM); Community Reinforcement Approach (CRA); and Cognitive Behavioral Therapy (CBT). There also are a number of behavioral approaches, such as exercise therapy, motivational interviewing, and twelve step facilitation with supportive evidence of effectiveness.

Contingency Management (CM) is a technique employing the systematic delivery of positive reinforcement for desired behaviors. In the treatment of stimulant use disorder, for example, vouchers or prizes can be “earned” for submission of methamphetamine- or cocaine-free urine samples or for attendance at treatment sessions. In most CM protocols, the value of the incentive is increased (escalation) as patients demonstrate the target behavior in consecutive urine analyses (UAs) or visits. If a positive UA or missed session occurs, the value of the incentive returns to the original value (reset).

Challenges to using CM in treatment settings include staff resistance to the idea of incentives (patients should not have to be “paid” or “bribed”; instead, motivation needs to come from within; recovery itself is the reward); uncertainty regarding the funding for incentives; and the belief that it is either illegal to offer full value cash or cash equivalent vouchers or that the incentives are restricted to being subthreshold/subtherapeutic.

In December 2020, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) issued a final rule in the Federal Register (Vol. 85, No. 232,  Pages 77684-77895) amending various regulatory protections under the Federal anti-kickback statute and civil monetary penalty rules that protect against fraud and abuse of Federal health care programs. The HHS OIG also made important clarifications.

In its Federal Register statement, the OIG corrected misimpressions about CM program incentives stating that there is no OIG imposed $75 limitation on such incentives. The OIG stated, however, that the Federal anti-kickback statute may constrain the ability of individuals or entities to offer CM program incentives of any value to Federal health care program beneficiaries, depending on the facts of the arrangement.  The OIG also expressed concern about heightened fraud and abuse risk when incentives are in the form of cash or cash equivalents, citing issues such as medical identity theft, misuse of patients’ Medicare numbers, inappropriate utilization (in the form of medically unnecessary items and services), and improper patient steering (including patients selecting a provider because the provider offers the most valuable incentives and not because of the quality of care the provider furnishes). It specified that incentives included in a Federal health care program would not implicate the Federal anti-kickback statute provided applicable billing and coverage rules are followed. Finally, OIG specified that … “incentives offered as part of a CMS [Centers for Medicaid and Medicare Services]-sponsored model may qualify for protection under the new safe harbor at paragraph 1001.952(ii).”   

Prior to the issuance of these clarified guidelines, the SAMHSA issued an announcement for State Opioid Response Grants (NOFO: TI-20-012, May 19, 2020) to develop and implement CM strategies to engage patients in care. Contingencies may be used to reward and incentivize treatment compliance with a maximum contingency value being $15 per contingency. Each patient may not receive contingencies totaling more than $75 per year of treatment.

The state of California has been approved by the CMS to launch a state contingency management pilot; this represents the first time CM has been formally approved as a benefit in the Medicaid program. Thus, a federal agency is willing to help pay for CM and provide $26.7 million in federal funding; California will increase the CM share to reach a total of $58.5 million. Thirty-seven out of 58 California counties are eligible to participate in the CM pilot, which will focus on stimulants, including cocaine and/or methamphetamine. Each patient can receive a maximum of $599 over six months. The actual roll out of the program will occur in July of 2022; the details are currently being negotiated with the counties and with providers.

The California Advancing and Innovating Medi-Cal (CalAIM) Contingency Management Pilot Program Policy Design addresses the roles and responsibilities of key stakeholders; county selection and implementation activities; the CM program approach; and reimbursement of CM activities, including reimbursement for incentives. It also includes plans for training and technical assistance, evaluation, outreach, and monitoring and oversight.

The CalAIM pilot permits incentives that have a direct connection to the coordination and management of care of the target population including for participation in community-based services that are recommended by the patient's licensed health care professional; the use of digital health technology such as remote patient monitoring and telehealth; and CM incentives for which the payer only pays when the desired health outcome, such as attendance or objective, validated measures consistent with treatment (e.g., attendance, abstinent drug tests, and other confirmed behavioral measures), occurs. It

disallows incentives that result in medically unnecessary or inappropriate items or services reimbursed in whole or in part by a Federal health care program; advertising patient incentives to recruit patients or steer patients away from other providers; using incentives for the purpose of increasing fees; and inadequate protection against fraud.

In general, incentives should advance goals, as determined by the patient’s licensed health provider, such as adherence to a treatment regimen, drug regimen, and/or follow-up care plan; management of a disease or condition, improvement in measurable evidence-based health outcomes for the patient or the target patient population; and ensuring patient safety. Incentives have been used successfully in other fields and there is no reason they should not be applied in alcohol and substance abuse treatment.

Discussion: Dr. Koob inquired research conducted on success rates in the CalAIM pilot; Dr. Clark responded that he is working with the University of California Los Angles that will evaluate the initiative using an implementation protocol to bridge research and practice. Dr. Koob noted that he supports CM for addiction because it gives the brain a window to re-adapt. He asked if there are plans to ease the person into a community management approach when the brain is more ready. Dr. Clark replied that he and his colleagues are encouraging a post-incentive phase to continue to engage the clients to foster longer-term impact. The pilot effort is engaging a diverse group of providers across the state so there is expected to be heterogeneity. Dr. O’Dell commented that she was surprised by the amount of funding; she asked if there are evidence-based practices regarding the financial amount of the incentive. Dr. Clark said that $75 is the nominal value that was supposed to be part of a safe harbor approach; however, it’s been clarified that this is not a requirement. $599 was chosen because a $600 incentive would require the issuance of 1099 forms that would place an administrative burden on agencies. CalAIM has requested that CMS and other government agencies treat the $500 as insurance rather than income; this issue has not yet been resolved. Constance Horgan, PhD., Inquired about reactions from providers, both at the organizational and individual levels. Are they on board? Dr. Clark explained that California uses a multi-stakeholder approach, working at the county level. It is currently engaged in conversations with counties and providers to learn what their issues are. Thus, specific providers are unknown at present. The goal is to be up and running in July; there is a great deal of preliminary legwork and state administrative processes that need to be completed first. These are the kinds of challenges that need to be addressed in moving from research to practice. Dr. Koob said that he looked forward to an update in the future on the outcomes of the pilot. Trish Powell, Ph.D., inquired about what research has suggested regarding the duration of time required for CM so that behaviors are preserved once the incentive is removed. Dr. Clark replied that there is a meta-analysis of previous studies that indicated an impact on behavior for up to one year. Results have indicated a positive impact not only on substance abuse issues but also on general health and wellness. Outcomes are also dependent on what the incentives were.

2022 Triennial Advisory Council Report on the Inclusion of Women and Minorities in Clinical Research

Dr. Koob introduced Bridget Williams-Simmons, Ph.D., Director, NIAAA Office of Science Policy and Communications and Associate Director of Basic Research, who highlighted key findings from a report summarizing the Institute’s efforts to comply with the NIH inclusion guidelines regarding women and minorities in NIAAA-supported clinical research (FY 2019-2021). The report presented aggregated enrollment data by sex/gender, race, and ethnicity. She noted that the report was previously sent to the Council members and  it is the Council’s responsibility to approve the report, certifying NIAAA’s compliance with the NIH inclusion guidelines.

As background, Dr. Williams-Simmons reviewed the requirements of the NIH Revitalization Act signed into law in 1993 that directed NIH to establish guidelines for inclusion of women and minorities in clinical research. The statute requires NIH to ensure that clinical trials are carried out in a manner sufficient to provide for a valid analysis of whether the variables being studied affect women or members of minority groups differently than other trial participants. It also requires that each Institute/Center (IC) Advisory Council prepare a report describing the manner in which the IC has complied with the statute. As a result, in 1994 NIH developed and issued a policy on the inclusion of women and minorities as participants in clinical research. The policy has been updated over the years to provide additional guidance, such as guidelines on minimum enrollment category standards and reporting differences in intervention effects for Phase III trials regarding sex/gender, race, and ethnicity.

The overall goal is to ensure that research findings can be generalizable to the entire population.

Strategies for ensuring compliance begin during peer review when reviewers evaluate inclusion plans in applications and make recommendations on the acceptability of the plan with respect to the inclusion policy. The Advisory Council serves as the second level of review and makes funding recommendations to the NIAAA Director based on the summary statement and other considerations. Program monitoring is performed by program officials who review inclusion information in the application for scientific appropriateness. They also monitor enrollment progress and provide consultation to Principal Investigators (PIs) when needed.

For intramural research, PIs provide inclusion plans that are considered during the annual scientific review and during Institutional Review Board (IRB) review renewal. Finally, NIAAA program and review staff receive inclusion training and have access to archived training and resources on the NIH intranet.

NIAAA Sex/Gender Enrollment in all NIH-Defined Clinical Research. Dr. Williams-Simmons presented a summary table of sex/gender enrollment in NIAAA clinical studies between FY 2019-2021. It showed very high male enrollment and low female enrollment percentages for FY 2019 and FY 2020, which is atypical for NIAAA, as well a significant decrease in total enrollment for FY 2021. These unusual enrollment patterns were influenced by two studies with more than 50,000 participants: the Veterans Aging Cohort Study (n=164,656) (FY 2019-2020) which was mostly male, Black/African-American or White, and non-Hispanic, and another project that used data from electronic health records from a regional health system in the Pacific Northwest (n=66,499) (FY 2021) in which enrollees were primarily female, White, and non-Hispanic. This study also had a relatively high representation of people who self-identified as Asian or unknown race compared to other race and ethnicity groups. When these large studies are excluded, the sex/gender percentages are more consistent across FY 2019-2021 (females 50.2-54.8 percent; males 42.6-47.5 percent).

NIAAA Clinical Research Enrollment by Race. Enrollment by race for FY 2019 and FY 2020 was relatively consistent with each other; however, there were fluctuations for all groups in FY 2021 and this was related to the two large studies cited above. When those studies were excluded, the percentages are fairly consistent across FY 2019-2021 (American Indian/Alaska Native 2.0-2.4 percent; More than One Race 3.2-4.0 percent), Asian 4.5-7.4 percent; Black/African American 17.1-23.1 percent; Native Hawaiian/Pacific Islander 0.4-1.6 percent; White 61.6-percent).

NIAAA Clinical Research Enrollment by Ethnicity. The enrollment of individuals in the Hispanic/Latino category ranged from 8.7 to 10.4 percent across the reporting period when the two large studies were included, and slightly higher (11.9-15.1 percent) when they were excluded.

Additional tables with enrollment by sex/gender and race and ethnicity are in the full report as well as enrollment for Phase III clinical studies which represent a very small fraction of NIAAA-supported studies. The data are also available online for sex/gender, race, and ethnicity by NIH Research, Condition, and Disease Classification (RCDC) reporting categories.

Discussion: Dr. Koob asked if there are more large studies that would influence enrollment patterns on the horizon. Dr. Williams-Simmons responded that in her opinion it’s unlikely, but possible. Dr. Sullivan commented that the report is encouraging because the representation of women in clinical research was impoverished for decades. Council members were asked to approve the report by voting in the chat function.

Motion to Accept the NIAAA Inclusion Report: A majority of Council members voted in the chat to approve the report.

Concept Clearance: HIV/AIDS: Ending the HIV Epidemic (EHE)

Dr. Koob introduced Kendall Bryant, Ph.D., NIAAA HIV/AIDS Coordinator, who presented a concept clearance for NIAAA’s approach to Ending the HIV Epidemic (EHE). Council members previously received a detailed plan for the concept.

EHE is a White House initiative launched in 2019 to reduce new HIV infections by 75 percent by 2025 and at least 90 percent by 2030. It targets resources to the 48 highest burden counties, Washington D.C., San Juan, PR, and seven states with substantial rural HIV burden. A new national plan for EHE released on December 1, 2021, expanded the initiative to address a broad group of substances, including alcohol. Alcohol is an important driver of the HIV epidemic, but questions remain about which alcohol interventions should be utilized.

The NIAAA initiative will focus on alcohol interventions that work to provide an early diagnosis for all individuals with HIV and identification and amelioration of alcohol use and associated mental health and substance use disorders that impact the prevention of HIV transmission in vulnerable populations,and treat HIV infection rapidly and effectively to achieve sustained viral suppression in the context of alcohol’s impact on adherence to life-long medication regimens reduce pathophysiological impact of continuing alcohol use.  In addition, the NIAAA initiative will focus on alcohol interventions that protect at-risk individuals who drink and are in “wet” environments (high density of liquor outlets that reinforce social norms that sustain unhealthy drinking) from acquiring HIV infection using proven HIV and Alcohol interventions, including pre-exposure prophylaxis (PrEP),  and rapidly detect and act on emerging HIV and alcohol clusters and prevent new infections within social networks of alcohol users, and alcohol-related disorders including depression, anxiety, pain, trauma, other substance use and medications that place individuals at greater risk for adverse outcomes.

A meta-analysis of the effectiveness of alcohol-related intervention studies indicated effect sizes of approximately 15 percent, with similar outcomes for activities around the use of PReP.

“Alcohol-Related Behavioral Research (ARBR): Integration into Primary and Secondary HIV Prevention Interventions” is a research initiative designed to be responsive to the NIH FY2021-2025 Strategic Plan for HIV/AIDS Research in the high priority areas of 1) Reduction in the Incidence and 2) Cross-Cutting Behavioral Research. The Cross-Cutting Behavioral Research area relates alcohol misuse, and patterns of alcohol consumption to ending the HIV epidemic in the US and beyond. Its high priority areas include the following.  1) Community Engagement increases understanding of community settings, where HIV prevention and treatment occurs, sheds light on behavioral and cultural practices within key populations and networks that influence HIV transmission and prevention and facilitates awareness of how behaviors are shaped by environmental, social, and structural factors. 2) Use of New Technologies increases widespread adoption of new technologies such as smartphones, mobile apps, social media, and text messaging as components of elemental ARBR offering new opportunities for monitoring HIV-related behaviors and for delivering tailored in-the-moment interventions. 3) Brief Messaging Interventions expands multidimensional HIV and Alcohol risk assessment and brief messaging interventions for rapid implementation by incorporation of comprehensive alcohol assessment and behavioral/polypharmacy risk messages into a series of behavioral interventions for people with HIV (PWH). 4) Patient-Provider Interactions increases patient and practitioner readiness to report willingness to change unhealthy alcohol and polypharmacy use after receiving personalized risk messages that incorporate direct alcohol measurement (Phosphatidyl ethanol or PeTH) value, other alcohol monitoring technology, and genetic/familial liability and uses of Artificial Intelligence (AI) to increase reliability of intervention effectiveness. 5) Environmental Factors provides assessment and mapping of additional environmental factors that increase risk for adverse outcomes and contribute to risk through social/behavioral and/or epigenetic phenomena (Envirome) to rapidly identify priority populations and geospatial locations where HIV is spreading and provide data-driven evidence-based guidance for public health decision-making to support the goals of EHE.

Within ARBR, applications  require the following  and  will be considered responsive. 1) Research should  focus on one of the geographically defined priority areas. 2) Projects  should not develop de novo health interventions with a primary aim of testing efficacy.  3) Research should involve one or more collaborations with local implementing partners. 4) Animal, drug discovery or device safety trials  with registrational requirements should not be included. 5) Studies should include a multidisciplinary team approach.

Dr. Bryant responded to questions from Council members based on their review of the concept. Christina Chambers, Ph.D., asked: Could some explicit mention of reproductive health/pregnancy be added with respect to ARBR and HIV? Dr. Bryant responded affirmatively, e.g., African American women bear the greatest HIV burden of the HIV epidemic in the United States, following MSM (men having sex with men) and individuals of transgender experience. African American women are over-represented, with the highest percentage of new HIV diagnoses in the Deep South. Furthermore, disproportionate risk of HIV among African American women residing in the Deep South collides with worsening access to healthcare (including reproductive care) and limited health literacy, economic underdevelopment, and insufficient social support infrastructure. Thus, intervention in this region and demographic, particularly in rural areas, is a critical key to ending the epidemic.

Katie Witkiewitz, Ph.D., asked why harm reduction approaches, community-based participatory research, and implementation science approaches are not explicitly mentioned in the concept, despite the fact that they will likely be most effective in having an impact in the highest risk communities. Dr. Bryant responded that these are appropriate approaches. The scope of the initiative allows for the widest range of appropriate intervention strategies to be evaluated for their effectiveness in multiple settings for reducing the incidence of new infections and improving the health of people with HIV who consume alcohol. Discussions of these approaches were highlighted in the December 1, 2021, national plan,

Dr. Witkiewitz also wondered whether neuroimaging research should be considered non-responsive to the concept, given that it is unlikely for neuroimaging findings to translate into community and individual health behavior change in the time designated for this concept. Dr. Bryant responded that it would be difficult to obtain and translate imaging research into an a readily applied assessment strategy due to time and cost. However, assessment of cognitive and affective functioning can be carried out with rapid screens (e.g., dementia, depression, etc.) that may impact the effectiveness of interventions. Further assessment using clinical imaging technology may be necessary but falls outside of this initiative. Individual levels of respondent burden need to be taken into account when trying to implement the “best” interventions.

Discussion: Dr. Koob commented that the focus on HIV and alcohol is a microcosm of the importance alcohol’s contribution to pathophysiology across many diseases. Dr. Witkiewitz thanked Dr. Bryant for addressing Council questions and for mentioning stress, pain, and the community-based aspects of the epidemic.

Action: Drs. Chambers, Witkiewitz, Sullivan, and Horgan endorsed the ARBR concept.

Ex Officio Report and Council Discussion: Ex-officio member Col. Charles S. Milliken, M.D., Department of Defense (DoD), announced that DoD has established a committee to address marijuana if the drug is recognized as legal at the federal level. He also noted DoD has moved all of its medical services from the individual branches into a centralized DoD agency; no additional funding has been provided. One concern for the Army is that behavioral health technicians have been well trained to conduct individual substance use assessments to extend provider reach in deployed settings; it’s unknown at present if such trainings will continue in the future. Dr. Koob commented that federal approval of marijuana will require additional research to address the combination of cannabis and alcohol.

Dr. Koob reiterated NIAAA’s hope that Council members will continue to be ambassadors to young researchers and those of diverse backgrounds; there is a fear that science will lose this generation due to the pandemic. He also noted that there will be a mental health “payback” from the pandemic; previous research on the 9/11 attack and on hurricanes has indicated a dose-response pattern in terms of alcohol consumption that the field must be prepared for. Dr. Powell and Executive Officer Vicki Buckley thanked Council members for their questions and comments.

Consideration of September Council Meeting Minutes, Future Meeting Dates

A majority of Council members voted via chat or email to approve the minutes of the NIAAA Advisory Council meeting held on September 9, 2021.

Dr. Bautista announced upcoming meeting dates for 2022-2024. In 2022, Council will meet on 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.

Adjournment

Dr. Koob adjourned the meeting at 4:26 p.m. 

CERTIFICATION

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