DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
147th Meeting of the
NATIONAL ADVISORY COUNCIL ON ALCOHOL ABUSE AND ALCOHOLISM
February 8, 2018
The National Advisory Council on Alcohol Abuse and Alcoholism (NIAAA) convened for its 147th meeting at 10:15 a.m. on Thursday, February 8, 2017, at NIAAA headquarters in Rockville, Maryland. The Council met in closed session at 9:10 to 9:45 a.m. to review the evaluation of the NIAAA intramural program, and at 9:45 a.m. to review grant applications; the review session recessed at 10:15 a.m. 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.
Louis E. Baxter, Sr., M.D
Howard C. Becker, Ph.D., ad hoc
Daniel J. Calac, M.D.
Carlo C. DiClemente, Ph.D.
Tom B. Donaldson
Alex M. Dopico, M.D., Ph.D.
Tatiana M. Foroud, Ph.D.
Robert J. Hitzemann, Ph.D.
Paul J. Kenny, Ph.D.
Joe L. Martinez, Ph.D.
Charles S. Milliken, M.D., ex-officio
Adolf Pfefferbaum, M.D.
Arun J. Sanyal, M.D.
Vijay H. Shah, M.D.
Rajita Sinha, Ph.D.
Frank A. Sloan, Ph.D.
Susan M. Smith, Ph.D.
Edith Vioni Sullivan, Ph.D., ad hoc
Constance M. Weisner, D.R.P.H.
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: Vicky Buckley, M.B.A.; Ralph Hingson, Sc.D., M.P.H.; M. Katherine Jung, Ph.D.; George Kunos, M.D., Ph.D.; Raye Litten, Ph.D.; Antonio Noronha, Ph.D.; Kenneth Warren, Ph.D.; Bridget Williams-Simmons, Ph.D.
Other Attendees at the Open Session:
Approximately 80 observers attended the open session, including representatives from constituency groups, liaison organizations, NIAAA staff, and members of the general public.
Call to Order and Introductions
NIAAA Director George Koob, Ph.D., called the open session of the Council meeting to order at 10:15 a.m. on Thursday, February 8, 2018. He introduced new ad hoc Council members Howard Becker, Ph.D., and Edith Sullivan, Ph.D., and expressed his appreciation for the contributions of departing Council members Adolf Pfefferbaum, M.D., and Rajita Sinha, Ph.D. Council members and senior NIAAA staff introduced themselves.
Dr. Koob highlighted key recent NIAAA activities, referring to the written Director’s Report, which was distributed to Council members.
- Staff Transitions: Robert Huebner, Ph.D., Acting Director of the Division of Treatment and Recovery Research (DTRR), retired at the end of 2017 after a distinguished career at NIAAA that began in 1988. He played a major role in the growth of NIAAA’s research portfolio on behavioral treatments and health services research and was actively involved in the Institute’s efforts to promote evidence-based therapies for alcohol use disorder (AUD) in everyday practice settings. Most recently, Dr. Huebner oversaw the development and implementation of NIAAA’s Alcohol Treatment Navigator. Dr. Huebner received a round of applause from the Council. Tony Jourdan, Ph.D., a Research Fellow in NIAAA’s Laboratory of Physiological Studies left NIAAA to join the Lipid Research Group at the University of Burgundy in Dijon, France as a tenure-track faculty member from the Institut National de la Santé et de la Recherche Médicale [INSERM]. Ming-Jiang Xu, M.D., Ph.D., a Research Fellow in NIAAA’s Laboratory of Liver Disease was recruited by Novo Nordisk as a Research Scientist in their newly established Research Center in Beijing, China.
- Budget: NIH received $34.1 billion for Fiscal Year (FY) 2017, which provided general increases to all NIH Institutes and Centers. NIAAA received $483.4 million, $16.7 million above the FY 2016 enacted level. This allowed for increases in research project grants, competing awards, and other research grants. There was a slight decrease in training positions. The FY 2017 budget included specific increases for Alzheimer’s disease research, antibiotic research, BRAIN Initiative, and Precision Medicine Initiative (now the All of Us Research Program), as well as continued support for the Gabriella Miller Kids First Pediatric Research Program. At present, the Institute is operating under a continuing Resolution (CR) until February 8, 2018 at midnight, pending a final FY 2018 budget. Following NIH policy under the CR, all grants are funded at 90 percent until a final budget is approved. Preliminary work on the FY 2019 budget has begun; the President’s budget request is forthcoming.
- Collaborative Research on Addiction at NIH (CRAN): The Adolescent Brain Cognitive Development (ABCD) Study has been a great success. More than 7,000 participants were enrolled as of February 7; projected enrollment will be 11,400 by the end of the study period. As of December 2017, recruitment was 96 percent on target for meeting sociodemographic recruitment goals. ABCD has partnered with the National Institute of Mental Health Data Archive (NDA) to share study data with the public in June 2018; curated data will be released annually through the NDA starting in February 2018. A publication process is under development for reporting the study findings. Coming soon will be a Funding Opportunity Announcement (FOA) to use ABCD data to answer questions about risk/protective factors for alcohol, drug, and nicotine misuse and their effects on the developing brain.
- New FOAs: New NIAAA FOAs include Interaction of HIV Infection and Alcohol Abuse on the Central Nervous System (CNS); Screening and Brief Alcohol Interventions in Underage and Young Adults; Alcohol Use Disorder (AUD): Behavioral Treatment, Services, and Recovery Research; Medications Development for AUD Treatment; Investigational New Drug (IND)-enabling the Development of Medications for AUD/Alcohol-related Disorders; Human Studies to Evaluate Promising Medications to Treat AUD; Increasing the Use of Medications for AUD Treatment; Comparative Effectiveness and Implementation of HIV/AIDS and Alcohol Interventions; Leveraging Electronic Health Records for Alcohol Services Research; Effects of In Utero Alcohol Exposure on Adult Health and Disease; Alcohol Impairment of Immune Function, Host Defense and Tissue Homeostasis; Wearable Alcohol Biosensors; Epidemiology and Prevention in Alcohol Research; and Program for Extramural/Intramural Alcohol Research Collaborations. In addition, NIAAA is currently participating in 40 NIH-wide FOAs.
- NIAAA’s Alcohol Treatment NavigatorSM: The Navigator is a website offering a comprehensive strategy to find evidence-based alcohol treatment launched October 2017 that has generated substantial interest. Drs. Koob and Lori Ducharme presented the Navigator at a Congressional briefing sponsored by the Friends of NIAAA and the Addiction, Treatment, and Recovery Caucus. Other promotional events have included a national webinar; radio appearances, interviews with the Associated Press, Alcohol & Drug Abuse Weekly, and National Public Radio; a Twitter chat (co-hosted with American Society for Addiction Medicine); a Facebook Live event (hosted by the Addiction Policy Forum); blog posts (Recovery Research Institute, SAMHSA’s ATTC network) ; and a presentation at the American Association for the Study of Liver Diseases annual meeting.
- Satellite Media Tour: Dr. Koob conducted a satellite media tour in January 2018 on recognizing signs of an alcohol-related problem and promoting the Alcohol Treatment NavigatorSM as a resource. The tour included a live listener call-in interview with Sirius XM Doctor Radio’s “Healthy Aging” program and an in-studio interview with KUSI-TV News/San Diego on January 8; 20 live and recorded interviews with television and radio stations around the country on January 9; and an in-studio interview with KUSI-TV News/San Diego on January 29. The combined reach of the satellite media tour is estimated to be 8.45 million individuals.
- National Conference on Alcohol and Opioid Use in in women and Girls-Advances in Prevention, Treatment, and Recovery: Co-chaired by NIAAA’s Deidra Roach, M.D., and hosted by NIAAA and the Women, Drinking, and Pregnancy Work Group of the Interagency Coordinating Committee on FASD on October26-27, 2017, this well-attended conference aimed to disseminate research and to develop a coalition of stakeholders to design a coordinated public-private response to epidemic substance misuse among women and girls. Dr. Roach also served as the scientific expert for a Twitter chat on women and alcohol held in December in partnership with the National Council on Alcoholism and Drug Dependence that garnered an estimated 5.3 million impressions and 1.48 million accounts reached.
- New NIAAA Director’s Blog: The blog launched on the NIAAA website in October 2017 to discuss significant advances in alcohol research and highlight NIAAA-supported work. The first post focused on the NIAAA Alcohol Treatment NavigatorSM.
- Looking Ahead: Dr. Koob congratulated George Kunos, M.D., Ph.D., on approval of an IND for JD-5037, the first in-class peripheral CB1 receptor antagonist for treatment of nonalcoholic steatohepatitis (NASH), by the Food & Drug Administration (FDA) based on preclinical studies by Dr. Kunos’ laboratory and IND-enabling studies supported by the National Center for Advancing Translational Sciences (NCATS) at NIH. Phase I studies are expected to begin in 2018. The 2018 Gordon Research Conference (GRC) on Alcohol and the Nervous System will be held March 4-9, 2018, in conjunction with the "Gordon Research Seminar (GRS) on Alcohol and the Nervous System,” March 3-4, 2018, in Galveston, Texas. The 4th Annual BRAIN Initiative Investigators Meeting will be held April 9-11, 2018, in Bethesda.
- NIAAA Research Highlights: Dr. Koob presented highlights of NIAAA-funded studies, both extramural and intramural:
“MicroRNA 181B-3P and its Target Importin Alpha5 Regulate Toll-Like Receptor 4 Signaling in Kupffer Cells and Liver Injury in Mice in Response to Ethanol” was published in Hepatology (2017 Aug), 66(20):602-615 [doi:10:1002/hep.29144.Epub 2017 Jul 4] by P Saikia, D Bellos, MR McMullen, KA Pollard, C de la Motte, and LE Nagy. They found that HA35 had an anti-inflammatory effect on Kupffer cells following ethanol treatment and that a specific micro RNA (miRNA), miR181b-3p, is dynamically regulated by HA35 and ethanol. These findings identify two potential new targets, HA35 and miR181b-3p, that may have therapeutic potential for the treatment of alcoholic liver disease.
“MicroRNA 122, Regulated by Grlh2, Protects Livers of Mice and Patients from Ethanol-induced Liver Disease” was published in Gastroenterology (2018 Jan), 154(1):238-252, by A Satishchandran, A Ambade, S Rao, YC Hsueh, A Iracheta-Vellve, D Tornai, P Lowe, B Gyongyosi, J Li, D Catalano, L Zhong, K Kodys, J Xie, S Bala, G Gao and G Szabo. They observed a reduction of miR122, the most abundant liver miRNA, in patients with alcoholic liver disease (ALD) and alcohol-fed mice. Increasing miR122 expression in mice mitigated alcohol-induced liver injury and fibrosis, whereas decreasing its expression increased inflammation, showing that alcohol-induced changes to the miR122 pathway play a role in developing ALD.
“Cannabidiol Attenuates Alcohol-induced Liver Steatosis, Metabolic Dysregulation, Inflammation and Neutrophil-mediated Injury” was published in Scientific Reports, (2017 Sept), 7(1):12064, by
Y Wang, P Mukhopadhyay, Z Cao, H Wang, D Feng, G Haskó, R Mechoulam, B Gao, and P Pacher. They investigated the effects of cannabidiol (CBD) on liver injury from chronic plus binge alcohol feeding in mice. Findings showed that CBD attenuates alcohol-induced liver injury by decreasing neutrophil-mediated injury, inflammation, and pathological metabolic reprograming, suggesting that CBD may be a novel treatment for ALD.
“Phosphodiesterase 4b Expression Plays a Major Role in Alcohol-induced Neuro-inflammation” was published in Neuropharmacology, (2017 Oct), 125: 376-385, by DV Avila, SA Myers, J-W Zhang, G Kharebava, CJ McClain, H-Y Kim, SR Whittemore, L Gobejishvili, and S Barve. They examined the causal role of phosphodiesterase 4b (Pde4b) expression in alcohol-induced brain inflammation in mice. Chronic alcohol feeding in mice increased Pde4b expression and brain inflammatory markers; administering a Pde4b inhibitor attenuated this increase, supporting phosphodiesterase inhibitors as potential treatment for alcohol-related conditions.
“Parallel, but Dissociable, Processing in Discrete Corticostriatal Inputs Encodes Skill Learning” was published in Neuron, (2017 Oct), 96(2):476-489.e5, by DA Kupferschmidt, K Juczewski, G Cui, KA Johnson, and DM Lovinger. They used fiber photometry to evaluate real-time activity of associative inputs from the medial prefrontal cortex to the dorsomedial striatum and sensorimotor inputs from motor cortex to dorsolateral striatum in mice. Associative and sensorimotor inputs showed co-engagement early in action learning and disengagement as actions refined. Disengagement of associative, but not sensorimotor, inputs predicted individual differences in subsequent skill learning. Divergent somatic and presynaptic engagement in both projections during early action learning suggests potential learning-related modulation of presynaptic corticostriatal function.
“Endocannabinoid Actions on Cortical Terminals Orchestrate Local Modulation of Dopamine Release in the Nucleus Accumbens” was published in Neuron, (2017 Dec), 96(5):1112-1126.e5, by Y Mateo, KA Johnson, DP Covey, BK Atwood, HL Wang, S Zhang, I Gildish, R Cachope, L Bellocchio, M Guzmán, M Morales, JF Cheer, and DM Lovinger. They used optogenetics to explore the role of cholinergic neurons in the nucleus accumbens (NAc) on dopamine transmission (DA). Findings showed that CB1 agonists and endocannabioids (eCBs) inhibited an increase in dopamine transmission both in the nucleus accumbens (NAc) and the prefrontal cortext (PFC). These same CB1 receptors also modulate optical self-stimulation maintained by PFC afferent activation in the NAc. The results establish local eCB actions on PFC terminals within the NAc that inhibit mesolimbic DA release and constrain reward-driven behavior.
“Enhanced Ventral Hippocampal Synaptic Transmission and Impaired Synaptic Plasticity in a Rodent Model of Alcohol Addiction Vulnerability” was published in Scientific Reports, (2017 Sept), 7(1):12300, by AG Almonte, SE Ewin, MI Mauterer, JW Morgan, ES Carter, and JL Weiner. Using a rodent model of adolescent social isolation, they showed that chronic stress impairs synaptic activities in the ventral hippocampus, a brain region important for mediating emotional behaviors. These neuroadaptations may contribute to an addiction-vulnerable phenotype associated with early-life stress.
“Methylomic Profiling and Replication Implicates Deregulation of PCSK9 in Alcohol Use Disorder (AUD) in Rodents and Humans” was published in Molecular Psychiatry, (2017 Aug), [Epub ahead of print], by FW Lohoff, JL Sorcher, AD Rosen, KL Mauro, RR Fanelli, R Momenan, CA Hodgkinson, LF Vendruscolo, GF Koob, M Schwandt, DT George, IS Jones, A Holmes, Z Zhou, MJ Xu, B Gao, H Sun, MJ Phillips, C Muench, and ZA Kaminsky. They analyzed genome-wide methylomic variation in people with AUD, and identified a differentially methylated region in the promoter of the PCSK9 gene. Mild alcohol use was associated with lower PCSK9 levels, a key regulator in cholesterol homeostasis in humans and rodents; heavy chronic use resulted in increased levels, in humans and rodents, linking alcohol use to epigenetic changes in PCSK9. This may explain the effects of alcohol on lipid metabolism and cardiovascular risk.
“Altered Brain Developmental Trajectories in Adolescents After Initiating Drinking” was published in the American Journal of Psychiatry (2017 Oct), [Epub ahead of print], by A Pfefferbaum, D Kwon, T Brumback, WK Thompson, K Cummins, SF Tapert, SA Brown, IM Colrain, FC Baker, D Prouty, MD De Bellis, DB Clark, BJ Nagel, W Chu, SH Park, KM Pohl, and EV Sullivan. Under the auspices of the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA), they examined adolescent brain growth associated with alcohol use. Magnetic resonance images (MRIs) quantified grey and white matter volumes. For no/low drinkers, gray matter volume declined while white matter regions grew. The general pattern followed a steeper trajectory of volume decline and faster rates of white matter growth in early adolescence followed by a deceleration as youths approached young adulthood. Heavy drinkers exhibited an accelerated frontal cortical gray matter trajectory, divergent from the norm.
“Exogenous Ghrelin Administration Increases Alcohol Self-administration and Modulates Brain Functional Activity in Heavy-drinking Alcohol-dependent Individuals” was published in Molecular Psychiatry, (2017 Nov), [Epub ahead of print], by M Farokhnia, EN Grodin, MR Lee, EN Oot, AN Blackburn, BL Stangl, ML Schwandt, LA Farinelli, R Momenan, VA Ramchandani, and L Leggio. They investigated the effects of IV ghrelin administration on alcohol self-administration (SA) in heavy-drinking individuals with alcohol-dependence and on reward processing using a fMRI-based task. Compared to placebo, ghrelin increased alcohol SA and amygdala activation in response to alcohol cues. Findings indicate that ghrelin could be a promising target for AUD medications.
“Rehabilitating the Addicted Brain with Transcranial Magnetic Stimulation” was published in Nature Reviews Neuroscience, (2017 Nov), 18: 685-693, by M Diana, T Raij, M Melis, A Nummenmaa, L Leggio, and A Bonci. They reviewed the neurobiological rationale for the potential use of repetitive transcranial magnetic stimulation (rTMS) to treat patients with addictive disorders. Preclinical and clinical studies indicate that changing specific brain circuits through rTMS of frontal brain regions results in substantial behavioral changes. This suggests that rTMS may be a useful treatment for addictive disorders.
“Effect of Varenicline Combined with Medical Management on AUD with Comorbid Cigarette Smoking: A Randomized Clinical Trial” was published in JAMA Psychiatry, (2017 Dec), [Epub ahead of print], by SS O’Malley, A Zweben, LM Fucito, R Wu, ME Piepmeier, DM Ockert, KW Bold, I Petrakis, S Muvvala, P Jatlow, and R Gueorguieva. They evaluated the efficacy of varenicline in a clinical trial in alcohol dependent individuals who also smoked cigarettes. Varenicline significantly reduced heavy drinking in men but not in women. Smoking cessation counseling was not provided, but varenicline resulted in higher smoking abstinence, consistent with the primary indication for varenicline.
“Cognitive Behavioral Interventions for Alcohol and Drug Use Disorders: Through the Stage Model and Back Again” was published in Psychology of Addictive Behaviors, (2017 Aug), [Epub ahead of print], by KM Carroll and BD Kiluk. They reviewed the deployment of Cognitive-Behavioral Therapy (CBT), an effective therapy for substance use disorders (SUDs). Little is known about the dissemination of CBT into healthcare settings or how technology could enhance implementation. They provide recommendations for avoiding this potential “implementation cliff” (intervention benefit drops when tested practices are scaled up) by offering a flexible, low-cost, standardized means of disseminating CBT in a range of novel settings and populations. They also discuss how technology, cognitive science, and neuroscience can increase understanding of how CBT works.
“Behavioral Interventions Targeting Alcohol Use Among People Living with HIV/AIDS: Systematic Review and Meta-analysis” was published in AIDS and Behavior, (2017 Nov), 21(Suppl 2):126-143, by LAJ Scott-Sheldon, KB Carey, BT Johnson, MP Carey, and MASH Research Team. They conducted a meta-analysis to evaluate the efficacy of behavioral interventions (an individual-level intervention addressing alcohol use alone or as part of a more comprehensive alcohol/HIV intervention) to reduce alcohol use among people living with HIV/AIDS (PLWHA). Interventions reduced high-risk alcohol, sexual, and non-adherent behaviors associated with secondary HIV transmission and poor clinical outcomes.
“Alcohol-related Emergency Department Visits in the U.S.: Results From the National Emergency Department Sample, 2006-2014” was published in Alcoholism: Clinical and Experimental Research, (2018, Jan), [Epub ahead of print], by A White, ME Slater, G Ng, R Hingson, and R Breslow. They evaluated national estimates of ED visits between 2006 and 2014 related to chronic and acute alcohol use among all ages. Findings indicate a 61% increase in the number of alcohol-related ED visits, with a 272% increase in costs of these visits. The increase in ED visits was higher among women than among men.
“Prevalence of Fetal Alcohol Spectrum Disorders in 4 US Communities” was published in the Journal of the American Medical Association (JAMA), (2018); 319(5):474-482, by PA May, CD Chambers, WO Kalberg, J Zellner, H Feldman, D Buckley, D Kopald, JM Hasken, R Xu, G Honerkamp-Smith, H Taras, MA Manning, LK Robinson, MP Adam, O Abdul-Rahman, K Vaux, T Jewett, AJ Elliott, JA Kable, N Akshoomoff, D Falk, JA Arroyo, D Hereld, EP Riley, ME Charness, CD Coles, KR Warren, KL Jones, and HE Hoyme. Under the auspices of the Collaboration on Fetal Alcohol Spectrum Disorders Prevalence (CoFASP) consortium, they used a standardized approach to collect data between 2010-2016 from 6,639 first graders and found a significant number have FASD. Conservative estimates of FASD prevalence at the four sites studied ranged from 1.1% – 5%. These data may represent more accurate US prevalence estimates than previous data based on small sample size, but may not be generalizable to all communities.
Elizabeth Powell, Ph.D., from NIAAA’s Division of Neuroscience & Behavior presented a request for concept clearance on alcohol sensitivity and tolerance developed in collaboration with Hemin Chin, Ph.D. Tolerance has been a neglected area of research in recent years; in past 20 years, from 1997- 2017, there were only 203 articles that addressed the underlying genetics and mechanisms, out of more than 8,000 citations on alcohol tolerance.
Tolerance is the decreased response to the effects of alcohol. It is dependent on multiple factors, including sex, age, dose, drinking pattern, and outcome measurement. For example, in one study among non-dependent alcohol drinkers, researchers asked subjects to abstain for 24 hours, measured their motor skills, and plotted the results against the number of days they drank alcohol over the previous 90 days. The more days these individuals drank alcohol, the less impaired their motor skills were. This is one definition of tolerance. A more sophisticated measurement is the driving simulator which measures motor, sensorimotor, and cognitive decision- making skills under the influence of alcohol. Thus, how tolerance is measured is a key factor in understanding the concept.
There are multiple forms of tolerance, dependent on time and dose. Acute tolerance is the response to a single dose. Rapid tolerance is inter-sessional tolerance measured within two to three days close to one another, in which the first dose is cleared through the body before the second occurs. This is the form of tolerance represented in most studies. Chronic tolerance reflects alcohol use over weeks to years; most data in this category are from self-report. Behavioral tolerance refers to differential responses depending upon conditioning, both Pavlovian and operant conditioning. All forms of tolerance are affected by metabolic tolerance, i.e., how the liver metabolizes alcohol.
Tolerance develops progressively over time and is affected by dose, drinking pattern, and alcohol sensitivity, which is influenced by factors such as sex and body size. It is unknown what happens to tolerance during and after periods of abstinence. In general, there are knowledge gaps in tolerance and its relationships with AUD, particularly in mechanisms and genetic Influences.
Innate tolerance (also called sensitivity) is highly variable and involves multiple phenotypes. Among the many attributes that influence innate tolerance are neural circuity and metabolism. An important rationale for studying tolerance is that innate tolerance (i.e., sensitivity) predicts the development of AUD, and development of the disorder may involve tolerance mechanisms.
Future directions for the study of tolerance include investigating 1) the mechanisms of tolerance, e.g., generating new hypotheses of cellular and molecular mechanisms or network models for chronic tolerance; identifying the relationship(s) between sensitivity and/or tolerance and creating predictive models for susceptibility for future alcohol use; identifying common parameters of sensitivity or tolerance between human subjects and animal studies; and establishing a neurobiological basis of tolerance, with candidates that serve as pharmacological targets for prevention and/or treatment of AUD; and 2) the genetics of alcohol sensitivity and tolerance, e.g., developing innovative strategies, integrating both experimental and bioinformatics approaches, to establish causality for candidate genes from genome-wide association studies (GWAS) and linkage studies; analyzing genomic, epigenetic, or transcriptional variations, and gene networks and pathways, including meta-analyses of multiple data sets, within and across studies; and translating research into model organisms, utilizing state-of-the-art gene-editing and gene delivery approaches, for in vivo validation of candidate genes, genetic variations, and gene networks from studies in human.
Discussion: Dr. Koob noted that NIAAA has not studied tolerance in the past 20 years. His interest in the topic was piqued by clinical question at the American Psychiatric Association about treatment outcomes in individuals with low sensitivity to alcohol and an extensive literature review put together Marc Schuckit, M.D., University of California, San Diego, the world’s pre-eminent researcher in this domain. Dr. Koob stated that the field now has modern techniques at the mechanistic and genetic levels that can be leveraged to increase knowledge about tolerance. Louis Baxter, M.D. applauded the emphasis on tolerance, which will enhance prevention and treatment. Rajita Sinha, Ph.D., agreed. She noted there are changes in neuro-endocrine levels before alcohol dependence starts; the field needs better markers for these changes because they predict AUD. She expressed hope that human laboratory and imaging studies will be included in future FOAs. Dr. Koob responded that clinical trials with imaging studies would not be included. Carlo DiClemente, Ph.D., suggested that the focus should begin with an examination of clinical individual differences in humans before moving on to animal studies. Daniel Calac, M.D., suggested research address high-risk groups, including American Indian/Native American populations, individuals from the pediatric population and women of child-bearing years, taking into account tolerance to alcohol and genetic characteristics. Tatiana Foroud, Ph.D., recommended adopting a broad approach, such as the one Dr. Powell described. Dr. Baxter encouraged NIAAA to include studies of long-term alcohol users who experience a decrease in tolerance and then become intoxicated more easily. Dr. Koob suggested that an ideal non-human primates study could test cohorts within a sample of genotyped monkeys for initial sensitivity and then examine which ones become heavy consumers, binge drinkers, etc. Paul Kenny, Ph.D., commented that some of the human genetics that make people vulnerable to alcohol dependence occur in the domains where the phenotype presents as tolerance. Dr. Koob concluded with the observation that it is extraordinary that NIAAA has done nothing on this topic since the late 1970s.
Consideration of Minutes of the September 2017 Council Meeting and Future Meeting Dates
Council members unanimously approved the minutes of the NIAAA Advisory Council meeting held September 14, 2017.
In 2018, the Council will meet on February 8, May 15, and September 13; the CRAN Council will meet on May 16, 2018. Council meetings in 2019 will be held on February 7, May 14, and September 12; the CRAN Council will meet in 2019 on May 15. In 2020, the Council will meet on February 6, May 12, and September 10; the CRAN Council will meet in 2020 on May 13.
Council broke for lunch at 11:51 p.m. and reconvened at 12:56 p.m. for the afternoon session.
Dr. Koob introduced Council member Dr. Daniel Calac who presented “The NARCH Student Development Program: A Model Program for Undergraduate Research Candidates in American Indian Communities.” There are approximately 4-7 million American Indians/Alaskan Natives (AI/AN) living in the United States. Greater than 60 percent live in urban areas. The AI/AN population is disproportionately under age 18, as AI/ANs experience a lifespan approximately 15 to 20 years shorter than those in the dominant culture, due to health disparities. The AI/AN population is extremely diverse: Over 520 federally recognized tribes inhabit the contiguous U.S., and over 350 distinct dialects/traditions exist among tribes that are co-located.
Barriers to assessing the Ai/AN population include financial, geographic, educational, health literacy, and cultural factors; these barriers contribute to health disparities. Data collection to assess these disparities is difficult. AI/NA groups are at severe risk for chronic diseases and their associated morbidities. The quality of the health care they receive is problematic, due to the diversity of health care sources they may use, such as urgent care clinics, hospitals, and walk-in clinics. Measuring these health care services remains a work in progress. There is little data to support interventions and few large-scale studies. Thus, the field for research is wide open, but research needs to be culturally appropriate.
The top health disparities issues affecting AI/NA people according to the Centers for Disease Prevention and Control (CDC) include limited community resources; variability in health literacy; lack of community engagement/awareness/participation; costs, resources, and other fiscal considerations; transportation challenges; potential displacement effects; variability in implementation; crime/safety influences; and lack of awareness of diverse norms and customs. For example, tribal members living in Montana may need to travel to Washington State or San Francisco to receive specialized medical services.
Attracting Native Americans to become health care providers is problematic. There was a 70 percent decline in the number of AI/NA applicants to medical school from 1996 to 2015, accompanied by a 63 percent decline in medical school acceptances to AI/NA applicants. There is also low representation of AI/NA faculty in medical schools, where they represent 0.1 percent of full-time faculty. Thus, there are few role models available to AI/NA medical students.
To address these problems, the California Native American Research Centers for Health (CA-NARCH) was founded 17 years ago. Its goals are to develop a cadre of Native American/Alaskan Native scientists and health professionals by providing comprehensive educational support to Native American/Alaskan Native students from high school through graduate school; increase the capacities of academic institutions and Native American organizations to work in partnership and reduce distrust; and facilitate competitive research linked to health priorities of Native American organizations to reduce health disparities.
Indian Health Council, Inc. (IHC) serves an area in northern San Diego County that comprises 2000 square miles and a population of 300,000. IHC runs multiple facilities in this service area, including a state-of-the-art 50,000 square foot medical center. NARCH operates collaboratively within IHC and with Palomar Community College, San Diego State University (SDSU), University of California San Diego, and California State University San Marcos (CSUSM) to conduct community based participatory research. Among its projects are Preventing Underage Drinking in Southern California Indians; Pill Take Back Project; Health Women: Healthy Native Nation; Tribal NOFAS (National Organization on Fetal Alcohol Syndrome); Tribal Institutional Review Board; Acupuncture & Diabetic Peripheral Neuropathy among Native Americans; Oral Flora, Periodontia and Vascular Dysfunction In Young Native Americans; Fatty Liver among Adolescent American Indians; and a Student Development Project.
The Student Development Project seeks to establish and support the student science pipeline by recruiting high school students and mentoring them from high school through doctoral programs via engagement in summer programs and internships, and offering culturally responsive mentoring, counseling, academic support, and skill building. Students participating in the program include students who identify as Native American/Alaskan Native (AI/NA); students in Science, Technology, Engineering and Math (STEM) fields who want to pursue a research career in health; students who are currently enrolled at UC San Diego, SDSU, CSUSM, or Palomar Community College; and students from both local and other tribes.
To date, CA-NARCH has supported over 100 students. Thirty-five 35 students have graduated from degree programs; many have graduated from multiple degrees. There are 13 students who are now working in Indian Country, fulfilling a major NARCH goal. Currently, the program supports seven graduate students, three community college students, and 12 undergraduates. Three students are working at IHC as research assistants or project coordinators. At NIH, one is in a post-baccalaureate program, one in a Ph.D. program, and three are participating in summer research programs. NARCH has placed students at NIH every year for the past five years where they have received outstanding mentoring and counseling support. NARCH also continues to mentor and place students during gap years, as their pursuit of a degree is often not linear.
Tribal donations have supported student travel to national conferences, CA-NARCH networking events, and academic support. It is the vested interest of the local Tribal community that is one of the touchstones of this program and makes it a success.
Experience has shown that students participating in the program experience many challenges, including academic ones compounded by excessive classes; too many extracurricular activities; family ties/expectations/needs; lack of financial support which often requires them to have full time jobs; and psychosocial stressors, such as missing tribal communities, families, and feeling isolated.
The major lesson learned from the Student Development Project is that success requires long-term engagement with the students. For example, researchers may need to be reminded that students are value-added resources and not burdens in the lab. Spending time with non-traditional “gap” students can be a good investment. The Project has also learned that students may need to be reminded that this is what they need to do to succeed. Peer to peer mentoring has also been helpful.
Unique features of the NARCH Student Development Project include mentoring students across multiple campuses and degrees; including “gap” students who still progress to master’s and doctoral programs; integrating research assistantships in tribal research; and leveraging NIH student training positions at all levels. Next steps for the Project are to improve evaluation to identify obstacles and motivating factors; work towards increased commitment among students to “give back;” and addressing how to support students who study out of the immediate geographic area.
Discussion: Vijay Shah, M.D., asked if there was a trend over time for students to assimilate into the dominant culture. Dr. Calac responded that some assimilation occurs; NARCH encourages students to maintain their cultural identities because otherwise they may not return to the rural areas where they are needed. However, they also need to remain in an academic institution to conduct research, so there is a large degree of assimilation. Carmen Albizu-Garcia, M.D., inquired if NARCH is associated with other Native American Centers of Excellence funded by the Health Resources & Services Administration (HRSA). Dr. Calac responded that it is not, but part of the challenge of sustainability is the need to establish more partnerships like this. He continued that NARCH can also learn from the best practices of these Centers, as well as other programs, such as those presented in previous Council presentations.
Dr. Koob introduced Mr. Tom Donaldson who represents the National Organization on Fetal Alcohol Syndrome (NOFAS). NOFAS is a public health and advocacy nonprofit organization that provides an FASD Information, Resource, and Referral Clearinghouse; entry-level care coordination and support for individuals living with FASD; public awareness campaigns (e.g., September is FASD Awareness Month); legislative and policy advocacy; and media outreach. NOFAS has an affiliate network of 32 groups across the country, as well as a birth mothers’ network called the Circle of Hope. NOFAS partners with NIAAA and professional associations, such as the American College of Obstetricians and Gynecologists, American Academy of Pediatrics, March of Dimes, and the National Alcohol Beverage Control Association.
An example of NOFAS’ media outreach is its press release of a new study about the prevalence of FASD that generated coverage in the New York Times, CNN, and other major news outlets. The study, published in the Journal of the American Medical Association (JAMA) (2018; 319(5):474-482) by PA May, CD Chambers, WO Kalberg, and colleagues reported that 3-10 percent of children may be affected by prenatal alcohol exposure. In comparison, diabetes affects nine percent of the population, and the Federal government spends approximately $2 billion annually on diabetes, far more than on FASD. Similarly, autism affects 1 in 68 children. Autism Speaks has an annual budget of $95 million, in contrast to NOFAS’ $750,000 budget.
Those at high risk for FASD may be found in the adoption and foster care systems; low socio-economic populations; incarcerated populations; and communities with high alcohol consumption rates. In the 1970s, people believed FASD mostly occurred among indigenous populations, but that has been shown to be untrue.
The Federal response to FASD has included NIAAA’s steadfast support. NIAAA expends about 7 to 8 percent of its extramural research and training budget toward its portfolio of approximately 90 FASD-related grants. There is also a Collaboration on Fetal Alcohol Spectrum Disorders Prevalence (CoFASP); a Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD); and an Interagency Coordinating Committee on Fetal Alcohol Spectrum Disorders (ICCFASD), which brings different agencies together to talk about the issue, but provides no funding. The CIFASD is the largest consortium at NIAAA on FASD. It coordinates basic, behavioral and clinical investigators in a multidisciplinary research project to better inform approaches aimed at developing effective intervention and treatment for FASD, and includes an administrative resource core, dysmorphology research resource, and an informatics component. It supports various research initiatives, including Early Predictors of FASD in Ukraine; Image Analysis of Neuro-facial Effects of Prenatal Alcohol Exposure (PAE); Exploring the Genetics of FASD in Complementary Mouse and Fish Models; A Multisite Neurobehavioral Assessment of FASD; Multi-modal Connectivity Methods for the Validation of FASD Diagnostic Criteria; Dissecting the Genetic Contributions to FASD; FASD in Adulthood: Health and Neurobehavior; Immune Dysregulation in FASD: Programming of Health and Neurobehavioral Outcomes; Development and Evaluation of an Evidence-Based Mobile Health Caregiver Intervention for FASD; Biomarker for Intellectual Disability in Children Prenatally Exposed to Alcohol; and Prenatal Alcohol Effects on the Gut Microbiome Contributing to Failure to Thrive and Altered Immune Function.
Other elements of the Federal response to FASD includes some line item funding for the Fetal Alcohol Syndrome Prevention Team in the National Center on Birth Defects and Developmental Disabilities at CDC; an FASD set-aside of less than $1 million within Special Projects of Regional and National Significance (SPRANS) in the Maternal and Child Health Bureau at HRSA; and a Congressional Caucus on Fetal Alcohol Spectrum Disorders that operated from 2004 to 2016. A new Congressional Caucus that addresses a wide range of prenatal issues is now in the planning stage.
According to NOFAS, “Fetal Alcohol Spectrum Disorders (FASD) is an umbrella term describing the range of effects that can occur in an individual who is prenatally exposed to alcohol. These effects may include physical, mental, behavioral, and/or learning disabilities with possible lifelong implications. The term FASD is not intended for use as a clinical diagnosis.” The disorder may include facial anomalies/growth deficits and central nervous system dysfunction, including behavioral and cognitive abnormalities. Alcohol may also cause Partial Fetal Alcohol Syndrome or Alcohol-Related Neurodevelopmental Disorder. An FASD diagnosis must be confirmed by maternal alcohol consumption.
The FASD profile may include brain and central nervous system problems, such as poor coordination or balance intellectual disability, learning disorders and delayed development; poor memory; trouble with attention and with processing information; difficulty with reasoning and problem-solving; difficulty identifying consequences of choices; poor judgment skills; jitteriness or hyperactivity; and rapidly changing moods. Social and behavioral issues may include difficulty in school; trouble getting along with others; poor social skills; trouble adapting to change or switching from one task to another; problems with behavior and impulse control; poor concept of time; problems staying on task; and difficulty planning or working toward a goal.
A 2016 paper in The Lancet, based on data from 127 studies, identified 428 comorbid conditions in individuals with FASD. The most prevalent disease conditions were congenital malformations, deformities, and mental and behavioral disorders. Five comorbid conditions with the highest prevalence included abnormal peripheral nervous system and special senses, conduct disorder, receptive language disorder, and expressive language disorder.
Individuals with FASD are at high risk for secondary disabilities, such as mental health problems, involvement with the juvenile justice system, etc. These often occur because the individual has not been diagnosed with FASD, and thus able to access support. Families report problems such as finding a doctor familiar with FASD or being denied insurance coverage for FASD-related treatment services. Thus, FASD is often regarded as a hidden disability.
The severity of alcohol’s effects on a fetus primarily depends on the quantity consumed per occasion; the frequency of consumption; and the timing (in what stage of pregnancy a woman drinks and if she drinks heavily just as the fetus develops a particular feature in the brain region). Children may be more affected by prenatal alcohol exposure if their mothers have poor nutrition; have had multiple pregnancies and births; have lower-than-average weight, height, and body mass index (BMI); smoke; are older; and/or are a member of a family of heavy drinkers.
Both genetic and environmental factors pose potential risks for FASD. The extent of FASD symptoms may depend on the mother’s genetic make-up, her child’s genetic make-up, and changes in gene activity caused by prenatal alcohol exposure. Children can be more affected by prenatal alcohol exposure if their mothers experience adverse-living conditions and high levels of stress; social isolation; living in circumstances where excessive drinking is common and accepted; and/or living in a community where resources for prenatal care are limited.
One in 10 pregnant women reported any alcohol use and 1 in 33 reported binge drinking, according to CDC’s Behavioral Risk Factor Surveillance System (2011-2013). Among pregnant women, the highest prevalence of any alcohol use was among those who were 35-44 years; college graduates; and not married. Over gestation, women drink less and less, but the high-risk period is at the beginning, when a woman may be unaware that she is pregnant. Therefore, there is a need for more education on preconceptual abstinence. In 1977, there was a public health advisory, instructing women not to drink more than two drinks per day. As the research evolved, so did the public health message. In 1981, the Surgeon General recommended abstinence during pregnancy for the first time and warning labels began appearing on alcohol bottles in 1989. Its efficacy as a public health strategy is unclear.
A recent NOFAS poll showed that more people want to be pointed to research about the effects of alcohol during pregnancy rather than an advisory. Thus, NOFAS seeks to take published research and translate the results into non-scientific language. It also offers personal stories from women whose children have FASD. This outreach is increasingly important as media stories that suggest that low or moderate prenatal alcohol exposure may be safe for women increase.
Birth mothers of children with FASD face a considerable amount of stigma. In one study, more people had disdain for a woman who drank when she was pregnant than if she was in jail or had an SUD. Forty-three states have some type of statute or have tried to sanction women for drinking alcohol during pregnancy. Often, the law favors punishment without mentioning access to treatment services. In Montana, the State Attorney’s office asks citizens to report women they observe drinking while pregnant. In some cases, servers have refused to serve a pregnant women alcohol, although that is not legal in most states. NOFAS does not endorse these approaches, and believes greater education is the better approach.
Alaska allows judges to consider FASD as a mitigating factor in non-violent criminal offenses. NOFAS supports this approach. Most media stories that mention FASD do so in the context of a criminal defendant using FASD as a defense. Half of these stories are about graphic crimes when people try to use FASD as a defense, but lack an actual diagnosis. NOFAS believes that people with an intellectual disability who commit a violent crime should not be sentenced to death.
NOFAS offers the following recommendations for addressing FASD: Amending the Individuals with Disabilities Education Act (IDEA) to Include individuals with an FASD for eligibility under Part C and Part B, providing technical assistance to identify children and youth with an FASD in Part D; and other priorities determined by the IDEA work group; modifying Medicaid and insurance coding policies to appropriately fund screening, diagnosis, treatment, and support services for individuals with an FASD; establishing standardized diagnostic criteria and guidelines; piloting screening and referral initiatives at medical, education, justice, and other system’s entry points; requiring FASD education and training for health care and mental health providers; establishing alcohol screening and brief intervention as part of routine clinical practice; creating new intervention approaches that can be assimilated into clinical practice, and establishing their efficacy; establishing a new longitudinal study to explore the long-term developmental course and outcomes of individuals with an FASD; expanding prevalence studies including among special populations such as inmates; conducting a comprehensive economic study on the range of costs to society and lost productivity related to the full continuum of FASD; obtaining accreditation for FASD curricula for medical and allied health students; including FASD in board examinations, licensing mechanisms, and continuing education; achieving full inclusion of Neurodevelopmental Disorder Associated with Prenatal Alcohol Exposure (ND-PAE) in the Diagnostic and Statistical Manual of Mental Disorders and inclusion of the full range of diagnostic conditions under the FASD umbrella in the 11th revision of the International Classification of Diseases (ICD-11); and providing case management and services to all children and adults living with FASD.
Discussion: Dr. Koob stated he thought NOFAS was a wonderful organization and wished that it had an $80 million budget. Dr. Smith reported on an experience at an FASD meeting in Vancouver where families and individuals affected by FASD spoke. She noted that the issues don’t go away when the individual with FASD turns 18 or 21. She asked NIAAA how the field could leverage research on this issue better as the population ages, because there are other health problems that co-occur with FASD. The challenge is that applications for such research don’t go to an alcohol review panel, but to a cardiology or other panel who don’t understand the role that alcohol and FASD plays. She asked how NIAAA could make this topic a higher priority. Kathy Jung, Ph.D., responded that NIAAA has recently released an FOA that addresses these issues. Dr. Smith inquired about who would be reviewing the applications. Dr. Koob responded that NIAAA has been working closely with the Center for Scientific Review (CSR) to ensure that study sections are not biased. He believes that alcohol-related applications have been fairly reviewed in recent times.
Dr. Koob introduced Dr. Baxter who addressed the role of alcohol in the opioid epidemic. He noted alcohol is often overlooked in conversations about the current opioid crisis. Thus, physicians and medical students are not getting the information they need about alcohol. According to the Surgeon General’s 2017 Report on Alcohol, Drugs, and Health, alcohol is a major player among SUDs. For example, in 2015, 66.7 million people in US reported binge drinking in the past month, compared to 27.1 million who were current abusers of illicit or prescription drugs. Alcohol misuse contributes to 88,000 deaths annually; in 2014, there were 47,055 overdose deaths from drugs. Of the annual costs from crime, health and lost productivity, $249 billion is due to AUDs, while $193 billion is due to illicit and prescription drug abuse. In comparison, other chronic medical illnesses cost $245 billion annually.
Alcohol’s role in general health status is not well understood by primary care providers, who often fail to evaluate alcohol use. Alcohol can affect the brain; heart; liver; pancreatitis; cancer and immunosuppression.
Alcohol and tobacco have been thought to be “gateway drugs” into addiction. In the United States,
66.7 million individuals aged 12 and older admit to binge drinking in the past month, while 27 million in reported illicit drug use during the same time period. Continued use of alcohol and or drugs can produce changes in the brain resulting in a SUD that impairs health and function, and that requires specialty addiction treatment.
When used together, alcohol and opioids can lead to over sedation and death (alcohol enhances the sedative effects of opioids). Dangerous side effects include nausea, changes in blood sugar leading to seizures, dehydration, arrhythmias, abnormal behavior, fainting and coma. There is often an emergency room (ER) dilemma in overdose management since naloxone is not effective in acute alcohol poisoning. The role of alcohol is frequently not considered by ER staff. However, alcohol has played a significant role in overdose death in studies dating back to studies in the 1990s. Alcohol was the single most common single drug factor in emergency department visits and overdose deaths in combination with opiates and or benzodiazepines.
Dr. Baxter raised the question of why alcohol has fallen off the radar screen. He identified several explanatory factors: Opioid use disorder (OUD) has been designated “a national health crisis.” There is less screening by primary care providers for alcohol use, misuse, and abuse, coupled with a lack of general basic knowledge regarding AUD, SUD and addiction, and their impact on the general health status of other diseases (e.g., cardiac, diabetes, hypertension, cancer, etc.). Alcohol gets lost in the pharmaceutical “specials of the day,” with pharmaceutical companies concentrating on drug development for OUD. Finally, primary care providers need to better education about how to refer and what to do when they identify AUD in a patient.
To raise alcohol’s standing in the hierarchy of SUDs, Dr. Baxter proposed recognition and education that alcohol is still a “gateway” drug used by children 12 and over; resurrecting Public Service Announcements (PSAs) for early education to children about alcohol; and communicating clearly that alcohol is very commonly used and abused as a secondary, if not primary, drug of choice in patients with SUD. He also recommended that alcohol and addiction education need to be part of the mandatory curriculum in all medical and allied health teaching institutions, and residency/fellowship programs; physicians who prescribe opioids should evaluate alcohol use history; screening for AUD needs to become part of standard health examination for all patients 12 years and older; and patients should be referred to addiction specialists for care and management whenever AUD is discovered.
Discussion: Dr. Koob emphasized that he is asking Council members to recommend the core content that physicians need to have, just as Dr. Baxter has outlined. NIAAA was previously referring to this content as the core curriculum, but is currently considering other descriptors. Dr. Calac commented that Dr. Baxter’s presentation was a great reminder of the medical education continuum. He endorsed the idea of having a core curriculum or knowledge base that medical schools can use so that alcohol is not overlooked during patient visits. Dr. Sinha inquired about the use of Vivitrol® in co-morbid patients, since it’s been shown to have equivalent outcomes with naloxone. Dr. Baxter responded that those who are being treated for OUD in a level of care where they’re continuing to use alcohol need to be moved to a higher level of care, per American Society of Addiction Medicine (ASAM) guidelines. Drugs alone are not sufficient treatment. They can assist, but rehabilitation counseling is also needed. Dr. Sinha agreed, but suggested looking further at Vivitrol® since there is insufficient research in the treatment of comorbid individuals. Dr. Koob interjected that this is not a high NIAAA priority given the extensive work already done on naltrexone as a treatment for AUD. Arun Sanyal, M.D., recommended making alcohol screening a practice quality standard as a way to achieve widespread implementation. This is a missed opportunity to engage with the U.S. Preventive Services Task Force (USPSTF). It may be worth revisiting the possibility of a National Academy of Medicine report on alcohol, particularly about alcohol and opioids, to identify gaps in medical education and practice patterns; this is the best way to get the attention of the USPSTF. Dr. Koob asked Dr. Sanyal to email that idea to Deputy Director Patricia Powell, Ph.D.
National Conference on Alcohol and Opioid Use in Women and Girls
Constance Weisner, D.R.P.H., reported on the National Conference on Alcohol and Opioid Use in Women and Girls on October 26-27, 2017, that Dr. Roach co-organized. Calling it an exciting experience, Dr. Weisner explained that it provided an important venue for assessing what is already known and where the knowledge gaps are. Speakers included Drs. Koob and Sinha, among others.
Dr. Weisner also observed that the conference served as a great model for integrative research, including prevention, treatment, and health services. It was also a good model for working collaboratively across federal agencies. The conference was well attended, with over 300 participants. The planning committee continues to have weekly meetings. Next steps include a website and webinars on topics that couldn’t be covered at the conference. In addition, another conference is being planned.
Dr. Koob reported that he has charged Dr. Roach with contacting each NIAAA division to find out what they’re doing about women and alcohol, and plans to work with Council about what the Institute should be doing.
Charles Milliken, M.D., reported that the National Defense Authorization Act (NDAA) recommended that the military services combine and coordinate their medical services under a single Department of Defense (DoD) operation. That transition is in the early stages. The Army has established a robust Level 1 outpatient treatment program; the majority of its providers are independently credentialed in addiction. If needed, he may request advice from members of Council to support the program in the future. Dr. Koob replied that NIAAA is already working closely with DoD on issues such as the interactions of alcohol with traumatic brain injury and PTSD.
Dr. Albizu-Garcia reminded Council members that Vivitrol® can precipitate withdrawal if the patient is still using opioids. Dr. Koob reiterated that NIAAA would not be studying this medication as a high priority because it already has been extensively studied by NIAAA and meta analyses provide evidence of its efficacy Dr. Calac asked if there was a website about the National Conference on Alcohol and Opioid Use in Women and Girls where he could obtain resources from it; Dr. Roach responded that a website is not yet available. She offered to send slides from the conference to Dr. Calac; Dr. Koob requested that she send them to all Council members. She noted that Dr. Koob’s presentation on alcohol and the female brain is posted on the NIAAA website, and announced that the first Conference follow-up webinar will be in late March and will focus on Hispanic women.
There were no public comments.
The meeting adjourned at 2: 56 p.m.
I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.