NIAAA Areas of Interest

The NIAAA supports research on the causes, prevention, control, and treatment of the major health problems of alcohol abuse, alcoholism, and alcohol-related problems. Through its extramural research programs, the NIAAA funds a wide range of basic and applied research to develop new and/or improved technologies and approaches for increasing the effectiveness of diagnosis, treatment, and prevention. The NIAAA also is concerned with strengthening research dissemination, scientific communications, public education, and data collection activities in the areas of its research programs.

For additional information about areas of interest to the NIAAA, see Small Business Opportunities.

Phase II Competing Renewal Awards

NIAAA will accept Phase II SBIR/STTR Competing Renewal grant applications to continue the process of developing products that require approval of a Federal regulatory agency (e.g., FDA, FCC). Such products include, but are not limited to: medical implants, drugs, vaccines, and new treatment or diagnostic tools that require FDA approval. This renewal grant should allow small businesses to get to a stage where interest and investment by third parties is more likely.

You are strongly encouraged to contact Dr. Max Guo (contact information provided below) before beginning the process of putting a Phase II Competing Renewal application together. Prospective applicants are also strongly encouraged to submit to Dr. Guo a letter of intent that includes the following information:

Descriptive title of the proposed research
Name, address, and telephone number of the Principal Investigator
Names of other key personnel
Participating institutions
Funding Opportunity Announcement Number (e.g., PA-07-XXX)

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and plan the review. It is expected that only a portion of NIAAA SBIR/STTR Phase II awards will be eligible for a competing renewal grant.

The following examples would make appropriate topics for proposed SBIR or STTR Phase II competing renewal projects.

These examples are meant for illustrative purposes and are not exclusive of other appropriate activities:

Preclinical studies, including pharmacology and toxicology, beyond those conducted under the Phase I (R43) and initial Phase II (R44) grants. Some in vivo or in vitro studies would be expected to have been carried out in Phase I or the initial Phase II grant.

Completion of studies as required by the Food and Drug Administration (FDA) for Investigational New Drug (IND) or Radioactive Drug Research Committee (RDRC) application.

Development and clinical evaluation of new alcohol-sensitive biomarkers.

Assessment of devices with regard to performance standards related to the FDA approval process.

Safety and effectiveness studies of novel medical devices.

Biocompatibility studies of surface materials of putative medical implants.

Evaluation of novel imaging approaches for diagnostic purposes.

Clinical studies in support of New Drug Application approval by the FDA

Clinical studies in support of Pre-Market Approval for biomarkers/medical devices by the FDA.

Direct your questions about scientific/research issues to:

Max Q. Guo, Ph.D.
Telephone: 301-443-0639
Fax: 301-594-0673
Email: qmugo@mail.nih.gov

Forward Letter of Intent to:

Max Q. Guo, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane
Bethesda, MD 20892
For Federal Express delivery, use:
Rockville, MD 20852-1705
Phone: 301-443-0639
Email: qmguo@mail.nih.gov

Pharmaceutical Development for Alcoholism Treatment

Applied and, where appropriate, clinical research on pharmacologic agents for use in the treatment or medical management of alcoholism, disorders resulting from alcoholism, the improvement and refinement of drugs currently available for therapeutic purposes, or drugs suitable for use in basic research studies on alcohol addiction. Areas that may be of interest to small businesses include, but are not limited to:

A. Development of agents to attenuate drinking behavior, e.g., drugs to curb craving.

B. Development of aversive agents such as disulfiram that attenuate drinking behavior.

C. Development of agents to treat acute alcohol withdrawal.

D. Development of agents to treat the protracted withdrawal syndrome.

E. Development of neurotransmitter agonists and antagonists, or drugs that enhance the efficacy of neurotransmission, which are capable of improving or reversing alcohol-induced cognitive impairments.

F. Development of agents to induce sobriety in intoxicated individuals (amethystic agents).

G. Development of agents to diminish drinking by treating associated psychiatric disorders and/or drug abuse.

H. Development of improved methods of drug delivery for the treatment of alcoholism. The systems developed must be capable of maintaining therapeutic drug levels for extended periods of time to alleviate compliance problems.

I. Development of drugs for the treatment of alcoholic hepatitis, cirrhosis, pancreatitis, and cardiomyopathy.

J. Research on the pharmacokinetics of concurrent ethanol and other drug use.

For clinical questions, contact:

Joanne B. Fertig, Ph.D.
301-443-0635
Email: jf75t@nih.gov

For pre-clinical questions, contact:

Mark Egli, Ph.D.
301-594-6382
Email: me114r@nih.gov

Diagnostic Assessment of Alcohol Use Disorders and Comorbidity

Innovative self-report and biochemical approaches to the early identification of alcohol use problems and diagnosis of alcohol use disorders and comorbidity are needed. The research design should include measurements of reliability and validity in appropriate population samples. Areas that may be of interest to small businesses include, but are not limited to:

A. Development or adaptation of diagnostic instruments measuring alcohol use disorders and related comorbid conditions in general population and treated samples, including youth, the elderly, pregnant women, ethnic minorities, the handicapped, and persons with low-level reading skills).

B. Development and testing of methodology to translate diagnostic instruments for alcohol use disorders and associated disabilities into relevant different languages (e.g., various Hispanic languages).

C. Development and testing of computer algorithms necessary to derive diagnoses of alcohol use disorders and associated comorbidity.

D. Development of computer software for utilization of assessment instruments in a clinical setting. Development and testing of detailed audio, visual, or printed training modules to accompany diagnostic instruments.

E. Application of statistical and mathematical analyses to develop models designed to increase our understanding of (1) etiologic relationship between alcohol use disorders and their associated disabilities, and (2) the factors that influence the initiation and maintenance of alcohol use disorders.

F. Identification, validation, and assay of physiological and/or biochemical measures capable of identifying individuals at risk for becoming alcoholics or individuals who already exhibit alcohol problems. The accurate measurement of acetaldehyde conjugates or abnormal glycoconjugates in blood is one promising approach.

G. Development of biochemical/physiological methods for early detection of alcohol-derived pathology, e.g., alcoholic hepatitis or cirrhosis. Development and characterization of markers to accurately predict vulnerability to alcohol-derived pathology.

Cherry Lowman, Ph.D.
301-443-0637
Email: clowman@mail.nih.gov

Treatment of Alcoholism

A. Development and evaluation of innovative treatment approaches. These approaches can include outreach, shelter, detoxification, treatment and recovery, and alcohol-free housing, as appropriate.

B. Development and validation of tools to aid in the clinical management of patients, including selection of appropriate interventions, process evaluation, assessment of outcome, aftercare, and patient tracking, in various treatment settings.

Cherry Lowman, Ph.D.
301-443-0637
Email: clowman@mail.nih.gov

Alcohol Biosensors and Data Analysis Systems

It is anticipated that innovative and improved alcohol sensors would be useful in a variety of situations including, but not limited to: clinical monitoring, forensics and human or animal research. Specific sensor characteristics would complement their intended use. This applies to characteristics such as: sampling frequency, degree of accuracy, data storage capacity and data transmission frequency.

Depending on their intended purpose and use, alcohol sensors may be augmented with additional information such as other physiological measurements or geospatial determinations.

Devices need to be compatible with human comfort, and devices to be worn for weeks or months may present particular challenges. Since alcohol readings are likely to be baseline most of the time, sensing devices generally require ways to monitor contact and readiness to record. Moreover, where necessary, measurement fidelity should be robust to subject's activities including active efforts at tampering.

The mode of data storage will need to conform to power limitations and strategies for data transmission which may require telemetry.

In addition to alcohol monitoring and data transmission this program also includes the opportunity to develop appropriate data analysis systems. Examples include: estimating blood alcohol concentrations, reconstructing patterns of alcohol consumption, and monitoring large numbers of devices to identify significant, but infrequent, events while minimizing false positives.

R. Thomas Gentry, Ph.D.
301-443-6009
Email: tgentry@niaaa.nih.gov

Promoting Adherence to Medical, Pharmacologic, and Behavioral Treatments

Several recent reports and literature reviews point to the continuing need for improving adherence to therapeutic regimens. Adherence rates vary considerably across diseases and treatments, measuring instruments, and populations, with rates ranging from 30% to 60% in many instances. The reasons for non-adherence are multifaceted. Health-care providers, organizational systems, and patient factors all play a role in adherence to therapeutic regimens. Thus, to understand and eventually improve adherence, conceptual frameworks and interventions need to take into account institutional, system, situational, interpersonal, and personal factors as well as the characteristics of the illness or condition and of the treatment regimen. While extensive research exists and successful techniques have been identified, greater efforts are needed to develop and implement programs based upon these findings. Applications are sought to develop:

A. Programs to implement effective interventions and to evaluate their implementation.

B. Professional education courses or web-based training modules on interventions and to monitor their effectiveness.

In both cases, the emphasis is on how to encourage health practitioners to utilize interventions that will improve their patients’ adherence to medical, pharmacologic, and behavioral regimens for alcohol abuse and dependence.

Margaret E. Mattson, Ph.D.
301-443-0638
Email: mmattson@mail.nih.gov

Prevention

Development and evaluation of innovative prevention/intervention programs, or specific materials for integration into existing programs, which utilize state-of-the-art technology and are based on currently accepted clinical and behavioral strategies. Applicants are strongly encouraged to consult with research methodologists and statisticians to ensure that state-of-the-art approaches to design, analysis, and interpretation of studies under this topic are used. Areas that may be of interest to small businesses include, but are not limited to:

A. Development and evaluation of innovative prevention/intervention programs, or specific materials for integration into existing programs, which utilize state-of-the-art technology and are based on currently accepted clinical and behavioral strategies. Special emphasis should be placed on the needs of high-risk groups, ethnic and minority populations, youth, children of alcoholics, women, the handicapped, and the elderly. Examples of such materials include school-based curricula, interactive videos, computer-based multimedia programs, training manuals for teachers or parents, and community-based programs.

B. Development and evaluation of educational materials designed to inform the elderly about specific age-related risks for alcohol problems. Particular attention should be given to age-related reductions in alcohol tolerance, interactions between alcohol and prescription and over-the-counter medications, possible exacerbation of some medical conditions common among the elderly, potential biomedical and behavioral consequences of excessive alcohol use, and the role of alcohol in falls, fires, burns, pedestrian and traffic injuries, and other unintentional injuries.

C. Development and evaluation of educational materials designed to provide information on date rape, spouse abuse, child abuse, and other types of violence that have been found to be associated with alcohol use and/or abuse. The development of strategies for preventing victimization would also be appropriate.

D. Development of instruments and educational materials designed to improve the effectiveness of employee assistance programs, especially with respect to assessment, referral, and health promotion as it relates to alcohol use and abuse.

E. Development and evaluation of statistical analysis programs tailored to the design and analysis of alcohol prevention-relevant research. Programs could focus on a variety of areas including: imputation of missing data under varying design assumptions; simulation of distributions of outcomes based on varying mixtures of sample populations; application of chronic or infectious disease models to targeted communities; and models of the potential effect of various policy-based interventions, such as increased taxation or reduction of outlet density by license revocation and control.

Robert C. Freeman, Ph.D.
301-443-8820
Email: rfreeman@mail.nih.gov

Health Services Research on Alcohol-Related Problems

Research projects are sought that will expand knowledge and improve delivery of alcohol treatment and prevention services. The research objectives include, but are not limited to: the effects of organizational structures and financing mechanisms on the availability, accessibility, utilization, delivery, content, quality, outcomes, and costs of alcohol treatment services. Objectives also include studying the effectiveness and cost-effectiveness of alcohol prevention services in reducing the demand for health care services and improving the methodological tools useful for conducting health services research. Areas that may be of interest to small businesses include, but are not limited to:

A. Development of protocols to assist in the identification, recruitment, and selection of treatment personnel to enhance the matching of staff to program needs.

B. Development of computer software or other protocols to assist in the management of treatment delivery. Software should be useful for assessment, diagnosis, patient placement criteria, monitoring of services received, tracking patient progress, and billing.

C. Development of software to assist clinicians in scoring and norming of commonly used assessment instruments. These packages should include protocols for guiding client feedback in a clinic or office-based setting.

D. Development of software or other protocols to assist treatment programs and service agencies in measuring, assessing, or otherwise documenting clinically relevant performance indicators or improvements in quality of service provision.

E. Development of protocols to facilitate the selection, implementation, adoption, and maintenance of evidence-based services consistent with target population need, staffing and program resources, and expected outcomes. These protocols should be flexible enough to work across a variety of settings and modalities.

F. Development of software or other protocols to facilitate the incorporation of screening and identification tools into routine usage in primary care, emergency, obstetric, mental health, and other health care settings. Research projects should facilitate both the provisions of brief interventions, medical management, effective referral to specialized alcohol treatment, and follow-up.

G. Development of software or other protocols for monitoring service costs of alcohol treatment services including core, ancillary, out-sourced services. These tools should provide a user-friendly system of monitoring costs that could be implemented without additional accounting expertise by the staff at a typical treatment setting. At the same time, such tools should be defensible as measures of the true opportunity costs of providing alcohol treatment services. Such software might be bundled with billing software.

Peter Delany, Ph.D.
301-443-0788
Email: delanyp@mail.nih.gov

Robert Huebner, Ph.D.
301-443-4344
Email: bhuebner@mail.nih.gov

Fetal Alcohol Syndrome (FAS) and Alcohol-Related Birth Defects

FASD is the collective term for the broad array of documented adverse effects resulting from in utero alcohol exposure. The most serious of these is fetal alcohol syndrome (FAS), a devastating developmental disorder characterized by craniofacial abnormalities, growth retardation, and nervous system impairments that may include mental retardation. Other diagnostic categories include partial FAS, alcohol-related neurodevelopmental disorder (ARND), and alcohol-related birth defects (ARBD). Children and adults with FASD may exhibit multiple cognitive, behavioral, and emotional deficits that impair daily functioning in many domains. The NIAAA supports research leading to improved diagnosis and assessment of impairment and disability, as well as the development of tools to enhance academic and daily living skills. Areas that may be of interest to small businesses include, but are not limited to:

A. Development of diagnostic and/or screening methods that can be used prenatally to identify fetuses affected by ethanol.

B. Development and validation of biomarkers that can be used to verify prenatal alcohol exposure in neonates.

C. Development and validation of assessment methods to provide more accurate clinical diagnosis of FASD at all life stages.

D. Development and testing of skill-building, therapeutic, and education program products that enhance the social, cognitive, adaptive and motor abilities of individuals with FASD.

E. Development of neurobehavioral tools or instruments to assess responsiveness of individuals with FASD to medications and/or cognitive/behavioral therapies.

F. Development of accurate measures of the responsiveness of children affected by prenatal exposure to alcohol to stress and predictors of vulnerability to alcohol-drinking or other psychopathology during adolescence and adulthood.

G. Development and evaluation of educational and training programs designed to enhance the skills of non-professional caregivers in dealing with the problems associated with FAS.

H. Development and validation of innovative approaches to prevent harmful drinking during pregnancy.

For basic research questions, contact:

Dale Hereld, M.D., Ph.D.
301-443-0912
Email: hereldd@mail.nih.gov

For prevention research questions, contact:

Marcia Scott, Ph.D.
301-402-6328
Email: mscott@mail.nih.gov

Science Education

The NIAAA Science Education program is intended to: (1) supplement in-service education of health professionals and paraprofessionals with respect to their recognition and treatment of alcohol-related medical problems; (2) stimulate the interest of both precollege and college students, especially among underserved populations, in career opportunities in the biomedical and behavioral sciences generally and the alcohol field specifically; (3) enhance precollege education in the classroom, both directly and via support to teachers, in the life sciences and in education regarding science-related personal and societal challenges; and (4) improve public understanding of science generally and with particular regard to the role of and need for alcohol research. The NIAAA Science Education program complements, but does not duplicate, the education and training components described under other NIAAA topics.

Efforts in science education might include, but are not limited to:

A. Development of methodology to transfer new alcohol research knowledge and directions of scientific knowledge growth to curriculum developers and science teachers, consistent with the National Research Council's National Science Education Standards (1996).

B. Development and testing of specific science education materials, activities or programs to implement one (or more) of the four stated objectives of the NIAAA science education program. The creative use of emerging educational and telecommunications technologies in this regard is of special interest.

C. Development and testing of methodology to present science and alcohol abuse-related curricula and educational materials to particular underserved group(s) in culturally relevant ways, and/or to obtain community support for education in science-related and alcohol-related topics that may be culturally sensitive.

D. Development of resource materials on scientific career opportunities in fields of interest to NIAAA, reflecting activities (e.g., focus groups) and research on motivational factors influencing high school students' career choices, and reflecting economic and social projections of career outlooks for the 21st century.

Roger Hartman
301-443-0276
Email: hartman1@mail.nih.gov

Research Tools

The NIAAA supports the development of new or improved tools to enhance the ability to conduct alcohol-related laboratory studies on humans and animals and to more effectively analyze data from large databases. Examples include transgenic animal models, cell lines, new ligands for neuroimaging, and simulators of alcohol impairment. Areas that may be of interest to small businesses include, but are not limited to:

A. Development of novel animal models, including transgenic animals, possessing specific traits of significance for the study of alcoholism, or for the study of specific pathologic disease states which arise from excessive alcohol consumption.

B. Development of a hepatocyte cell line capable of maintaining viability and metabolic functions in culture systems for an indefinite period.

C. Development of new methods of ethanol administration to animals that produce precise dose control.

D. Development of specialized cell culture chambers to provide controlled administration of ethanol to in vitro cell systems.

E. Development of ligands for alcohol-relevant neurotransmitter systems which will enhance the potential usefulness of PET and SPECT imaging technologies for the study of the etiology of alcoholism and related brain pathology.

F. Development of instruments that simulate driving, piloting aircraft, or using other complex machinery under hypothetical or actual drinking handicaps and are designed to predict fatal and nonfatal accident involvement.

G. Development of computational, statistical or bioinformatics tools to organize and manage high throughput data obtained by proteomics, metabolomics, or functional genomics strategies.

H. Development of databases, methods for integration of databases, or data analysis systems for alcohol research.

I. Development of non-invasive or minimally invasive alcohol detection biosensors with sensitivity and specificity appropriate for laboratory research with humans or animals (see also Alcohol Biosensors and Data Analysis Systems).

Dale Hereld, M.D., Ph.D.
301-443-0912
Email: hereldd@mail.nih.gov

Development and Clinical Testing of Biochemical Markers

The development of effective biochemical markers represents a powerful means for early diagnosis and treatment of alcohol dependent/abuse patients and for the identification of individuals who have a predisposition for alcoholism. There are two different types of biochemical markers: trait markers and state markers.

Trait biomarkers have the ability to detect inborn characteristics of individuals who are vulnerable for alcoholism. This type of marker would be invaluable for screening of high-risk individuals (e.g., children of alcoholics) and targeting them with preventive or early treatment interventions. In addition, trait markers might assist practitioners in identifying subpopulations of alcoholics who may need different treatment strategies. An ideal trait marker should have several features. First, it should display validity in detecting people susceptible to alcoholism, particularly before the onset of alcoholism or during periods of stable abstinence. Second, it should be easily and reliably measured. Third, it should be specific for alcoholism only and not affected by other medical or psychiatric disorders or drugs. Since alcoholism is a complex disease, it is likely that more than one type of gene and protein exist as trait marker.

State markers or markers of alcohol consumption serve several important purposes. First, they can assist physicians in diagnosing individuals with chronic drinking problems, particularly patients who deny excessive drinking. Moreover, they may also identify individuals in early stages of heavy drinking, thus avoiding the long-term medical, psychological, and social consequences of chronic alcoholism. Second, state biomarkers can aid in the diagnosis and treatment of other diseases (liver diseases, pancreatitis, and cardiovascular diseases) that were, at least, caused by excessive drinking. Third, they are useful in alcohol treatment and prevention programs. Since the goal of many of programs is abstinence, monitoring relapse is important in gauging success. Last, state biomarkers are important in clinical alcohol trials. Although self-reports have become more sophisticated and valid (e.g., Timeline Followback), they still rely on accurate reporting. These new and reliable biomarkers could then be used to confirm the self-report. Several biomarkers with certain limitations are currently in use including carbohydrate-deficient transferrin (CDT), gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and mean corpuscular volume (MCV). New state markers need to be developed that incorporate the following attributes: validity, reliability, stability, cost, practicability, acceptability, and transportability.

Areas that may be of interest to small businesses include, but are not limited to:

A. Develop and evaluate clinically alcohol-sensitive biomarkers to identify individuals who are predisposed to alcoholism; determine relapse; measure levels of drinking; and determine alcohol-induced tissue damage.

B. Identify genes, and proteins that are expressed during the development of alcohol dependence for biomarker development.

C. Develop methodologies for high throughput identification of alcohol metabolites and other signaling molecules that are expressed during alcohol intake.

D. Use knowledge of genetic and molecular mechanisms underlying alcohol-induced organ damage (including alcohol-related liver, pancreas, heart disease and FAS) to develop new biomarkers of tissue and cell damage.

E. Evaluate clinically innovative alcohol-sensitive biomarkers (trait, relapse, organ damage) for sensitivity and specificity.

For clinical questions contact:

Raye Z. Litten, Ph.D.
301-443-0636
Email: rlitten@niaaa.nih.gov

For pre-clinical questions, contact:

Dale Hereld, M.D., Ph.D.
301-443-0912
Email: hereldd@mail.nih.gov

Other Research Topic(s) Within the Mission of the Institute

For additional information on research topics, contact:

For administrative and business management questions, contact:

Ms. Judy Fox
Grants Management Officer
National Institute on Alcohol Abuse and Alcoholism
Phone: 301-443-4704, Fax: 301-443-3891
Email: js182a@nih.gov

Updated: July 30, 2008