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Clinical Testing of Biochemical Markers

Description:

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.

Raye Z. Litten, Ph.D.

301-443-0636

Email: Raye.Litten@nih.gov

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