Research Highlights

Research News
Wednesday, February 21, 2018
Author:
The purpose of this workshop is to address challenges related to clinical trial designs and drug development in Alcoholic Associated Liver Disease (AALD) and Alcoholic Hepatitis (AH) including populations to study, endpoints, and diagnostic criteria.  For additional details visit https://niaaa.nih.gov/alcoholic-hepatitis-workshop-fda-niaaa-aasld
 
 
Alcoholic Hepatitis Workshop FDA, NIAAA, AASLD Clinical Trial Endpoints for AH
Date: March 26-27, 2018
 
 
Location: Food and Drug Administration Great Room – White Oak Campus 10903 New Hampshire Ave., Silver Spring, MD
 
 
Registration Information: 
 
 

 

Logistics Contact:
Bridgette Green, NIAAA
greenbd@mail.nih.gov

 

Sponsors: 

• Food and Drug Administration (FDA)
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• American Association for the Study of Liver Diseases (AASLD)
• American College of Gastroenterology (ACG)
• American Gastroenterological Association (AGA)

 

 

 

Research News
Tuesday, February 13, 2018
Author:

More than 7,500 children recruited for study to date; data available for first 4,500

The National Institutes of Health today released to the scientific community an unparalleled dataset from the Adolescent Brain Cognitive Development (ABCD) study. To date, more than 7,500 youth and their families have been recruited for the study, well over half the participant goal.  Approximately 30 terabytes of data (about three times the size of the Library of Congress collection), obtained from the first 4,500 participants, will be available to scientists worldwide to conduct research on the many factors that influence brain, cognitive, social, and emotional development. The ABCD study is the largest long-term study of brain development and child health in the United States. MRI of adolescent brains activated during a memory task in ABCD study. Source Dr. Richard Watts

This interim release provides high-quality baseline data on a large sample of 9-10-year-old children, including basic participant demographics, assessments of physical and mental health, substance use, culture and environment, neurocognition, tabulated structural and functional neuroimaging data, and minimally processed brain images, as well as biological data such as pubertal hormone analyses. The data will be made available through the National Institute of Mental Health (NIMH) Data Archive, which can be accessed by researchers who obtain a free NIMH Data Archive account. All personally identifiable information is removed from the data to ensure participant confidentiality and anonymity.

"By sharing this interim baseline dataset with researchers now, the ABCD study is enabling scientists to begin analyzing and publishing novel research on the developing adolescent brain," said Nora D. Volkow, M.D., director of the National Institute on Drug Abuse (NIDA). "As expected, drug use is minimal among this young cohort, which is critical because it will allow us to compare brain images before and after substance use begins within individuals who start using, providing needed insight into how experimentation with drugs, alcohol and nicotine affect developing brains." 

"Sharing ABCD data and other related datasets with the research community, in an infrastructure that allows easy query, data access, and cloud computation, will help us understand many aspects of health and human development." said Joshua A. Gordon, M.D., Ph.D., director of NIMH. "These datasets provide extraordinary opportunities for computational neuroscientists to address problems with direct public health relevance."

This comprehensive dataset, which will be disaggregated by sex, racial/ethnic group, and socioeconomic status, will allow researchers to address numerous questions related to adolescent brain development to help inform future prevention and treatment efforts, public health strategies and policy decisions, including, but not limited to:

  • How do sports injuries impact developmental outcomes?

  • What is the relationship between screen time and brain and social development?

  • How does the occasional versus regular use of substances (e.g., alcohol, nicotine, marijuana) affect learning and the developing brain?

  • What are some of the factors that contribute to achievement gaps?

  • How do sleep, nutrition, and physical activity affect learning, brain development and other health outcomes across racial/ethnic and socioeconomic groups?

  • What brain pathways are associated with the onset and progression of mental health disorders and do these pathways differ by sex?

  • What is the relationship between substance use and mental illness?  

  • How do genetic and environmental factors contribute to brain development?

"The collection and release of this baseline data is a crucial step in ongoing efforts to sharpen our understanding of the link between adolescent alcohol use and long-term harmful effects on brain development and function," said George F. Koob, Ph.D., director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

Recruitment of participants began in September 2016 through outreach to public, charter, and private schools, as well as twin registries in Colorado, Minnesota, Missouri and Virginia. The ABCD Study is designed to include a diverse population that reflects the demographics of the U.S., however these interim data may not fully capture that diversity as enrollment is not yet complete. So far, 7,637 youth have been enrolled, including 6,399 single participants and 1,238 twins/multiples, reaching a 66 percent recruitment milestone. The study aims to enroll a total of 11,500 children by the end of 2018. The next annual data release will include the full participant cohort.

Participants will be followed for 10 years, during which data are collected on a semi-annual and annual basis through interviews and behavioral testing. Neuroimaging data, including high resolution MRI, are collected every two years to measure changes in brain structure and function.

The ABCD Coordinating Center. and Data Analysis and Informatics Center are housed at the University of California, San Diego and recruitment is being conducted at 21 study sites across the country. For more information, please visit the ABCD website at www.ABCDStudy.org.

The ABCD study is supported by the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the National Cancer Institute, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of Mental Health, the National Institute on Minority Health and Health Disparities, the National Institute of Neurological Disorders and Stroke, the NIH Office of Behavioral and Social Sciences Research, the NIH Office of Research on Women’s Health, and the Division of School Health at the Centers for Disease Control and Prevention (CDC), with additional partnerships with the National Institute of Justice, the CDC Division of Violence Prevention, the National Science Foundation, and the National Endowment for the Arts.

Read the full news release at www.drugabuse.gov/news-events/news-releases/2018/02/nih-releases-first-dataset-unprecedented-study-adolescent-brain-development

 

 

Research News
Wednesday, January 31, 2018
Author:

NIAAA seeks volunteers for a research study on alcohol use disorder aimed at reducing craving for alcohol.

Background:
Hormones are naturally occurring chemicals in the body. Ghrelin is a hormone that stimulates appetite. It may also stimulate alcohol cravings and use. Researchers want to learn more about alcohol cravings and test if a drug that blocks ghrelin lowers alcohol cravings.  

Learn more at https://clinicalstudies.info.nih.gov/html/InternalProtocols/A_2016-AA-0080.html

 

Join a Study NIAAA clinical research

 

Office of the Clinical Director, NIAAA

 

 

Research News
Monday, May 1, 2017
Author:
Many alcohol studies rely on participants to self-report how much and how often they drink, which can, at times, result in unreliable data. Biomarkers (biological markers) based on indicators in blood or other bodily fluids can be objective measures of alcohol use. Some biomarkers directly measure whether an individual has recently been drinking by measuring components of alcohol in blood or urine after it is metabolized. Other biomarkers work by detecting the toxic effects that alcohol misuse may be having over time on organ systems or body chemistry, indirectly signaling an alcohol problem. Biomarkers have a variety of uses, including screening for possible alcohol problems in people who are unwilling or unable to provide accurate self-reports of their drinking, and objectively showing that someone with alcohol use disorder has abstained from drinking.
 
However, there are limitations to using currently recognized biomarkers. Some biomarkers are less accurate in certain groups, such as women and younger individuals, and it is often difficult to interpret the type of drinking (quantity/duration) measured by the biomarker. For these reasons, it is recommended that biomarkers be used in conjunction with self-report.
But what if researchers had access to a tool that could give perfectly accurate data about a person’s drinking?
 
To this end, NIAAA is once again challenging the biotech community to design a wearable device capable of measuring blood alcohol in near real-time. This time, however, developers are being tasked with creating a device that measures alcohol concentration in the blood or in the interstitial fluid that surrounds the body’s cells, as opposed to using technology that detects alcohol released through the skin in sweat or vapor. As in the first competition, the ideal biosensor would be capable of measuring alcohol levels noninvasively as a sleek and unobtrusive device. The creators of the winning prototype will be awarded $200,000 through Challenge.gov, which lists federal incentive prizes and competitions. The second place developers will receive $100,000.
 
“Our first Challenge was a huge success. The winning devices made important strides in improving transdermal alcohol sensing,” says NIAAA Director George F. Koob, Ph.D.
 
In May 2016, NIAAA announced that BACtrack had won the first Wearable Alcohol Biosensor Challenge with its Skyn prototype. The wrist-worn device detects blood alcohol concentration (BAC) using a fuel-cell technology similar to that in devices used by law enforcement for roadside alcohol testing. MILO, Inc., won second prize for its design using disposable cartridges to continuously track BAC.
 
“We have learned that there is real interest in the private sector around wearable alcohol biosensors, and that innovation using distinct means of alcohol detection is on the horizon,” says M. Katherine Jung, Ph.D., Director of NIAAA’s Division of Metabolism and Health Effects, and co-leader of the competition.
 
Innovation is encouraged, and creative solutions could include, but are not limited to, the adaptation and miniaturization of technologies such as spectroscopy or wave technology.
“We want to continue to harness the power of the private sector, because if alcohol biosensors become a part of the ‘wearable toolbox,’ then tangible new opportunities will become available that can profoundly affect the field of alcohol research,” says Dr. Jung.
 
In addition to its potential for researchers, alcohol biosensors could also be a tool for consumers who wish to track their personal drinking patterns.
 
Competition submissions (a working prototype, data proving functionality/reliability, and photos/videos) will be accepted until May 15, 2017, with winners announced on or after August 1, 2017.
 
 
 
Research News
Friday, February 24, 2017
Author:
The effects of alcohol use during pregnancy on an unborn child are well known. However, a recent NIAAA-funded study in rats has shown that a mother’s alcohol use before conception also could have negative effects on her child’s health and response to stress during adulthood.
 
To study the effects of preconception alcohol use, the research team, led by Dipak Sarkar, Ph.D., at Rutgers University, gave female rats 4 weeks of access to a diet containing 6.7 percent alcohol, which raised their blood alcohol levels similar to that of binge drinking in humans. Alcohol was then removed from the rats’ diet, and they were bred 3 weeks later. After the rats’ offspring reached adulthood, the researchers used standard laboratory techniques to evaluate their response to stress, anxiety-like behaviors, changes in levels of stress regulatory genes and protein hormones, as well as epigenetic changes—chemical modifications to DNA that occur in the absence of changes in sequence and can alter gene function.
 
The team found that offspring of rats that were exposed to alcohol before conception had increased levels of stress hormones in their blood in response to an immune challenge and changes in the expression and epigenetic profiles of genes that play a role in regulating stress responses in their brains. However, the researchers observed changes in anxiety-like behaviors only in the male offspring.
 
Previous research has indicated that epigenetic mutations may be passed from parent to child and also that epigenetic mutations may play a role in the expression of anxiety-linked behaviors and response to stress. Alcohol problems are known to run in families, and increased alcohol consumption in humans has been associated with increased anxiety.
 
Taken together, these findings suggest that epigenetic changes in the mother as a result of alcohol misuse before conception may be passed on to her offspring. These changes could have lifelong effects on a child’s response to stress.
 
Reference:
 
Jabbar, S.; Chastain, L.G.; Gangisetty, O.; Cabrera, M.A.; Sochacki, K.; and Sarkar, D.K. Preconception alcohol increases offspring vulnerability to stress. Neuropsychopharmacology 41(11):2782–2793, 2016. PMID: 27296153
 

Reprinted from the NIAAA Spectrum, Volume 9, Issue 1, February 2017.

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