Method of establishing a genetic risk stratificastion for genetic addiction risk analysis

Abstract

Methods and kits for assessing severity index for alcohol abuse, drug abuse, and other reward deficiency syndromes. It has been discovered that a multifaceted non-specific RDS behaviors should be considered as the true “reward” phenotype (endophenotype) instead of a single subset RDS behavior such as alcoholism. In an embodiment of the present invention, it has been discovered that there are at least eleven risk alleles associated with ten candidate genes. The methods and kits of the present invention satisfy the need to classify patients at genetic risk for drug/alcohol seeking behavior prior to or upon entry to residential and or non-residential chemical dependency and pain programs.

1 - 13 . (canceled) 
     
     
         14 . A method of establishing a genetic risk stratification of a plurality of ranges for genetic addictive risk analysis, wherein the method comprises the steps of:
 (a) selecting a plurality of alleles, wherein
 (i) each of the alleles in the plurality of alleles is associated with a gene in a plurality of genes, 
 (ii) there are at least ten genes in the plurality of genes, and 
 (iii) there is at least one allele for each of the genes in the plurality of genes; 
   (b) performing an allelic analysis using the plurality of alleles on a plurality of subjects, wherein
 (i) the plurality of subjects comprises a statistically informative sample of subjects, 
 (ii) each of the subjects in the plurality of subjects have a non-allelic risk score, and 
 (iii) the non-allelic risk score having been determined independent of the allelic analysis; 
   (c) assigning a count for each of the alleles in the plurality of pre-determined alleles that was present in the biological sample;   (d) determining an allelic risk score for each subject in the plurality of subjects based upon the count; and   (e) comparatively analyzing the non-allelic risk scores and the allelic risk scores, wherein
 (i) the comparative analysis results in establishing that the allelic risk score significantly predicts the non-allelic score of the plurality of subjects, and 
 (ii) the significant prediction is at a p-value of at most 0.05. 
   
     
     
         15 . The method of  claim 14 , wherein the p-value is at most 0.01. 
     
     
         16 . The method of  claim 14 , wherein at least five of the alleles in the plurality of alleles are selected from the group consisting of:
 (a) allele G of gene DRD1;   (b) allele A1 of gene DRD2;   (c) allele C of gene DRD3;   (d) allele C of gene DRD4;   (e) allele 9R of gene DAT1;   (f) allele 7-11R of gene DRD4;   (g) allele S or L of gene HTTLPR;   (h) allele 4R of gene MAOA;   (i) allele G of gene COMT;   (j) allele G of gene OPRM1; and   (k) allele 181 of gene GABRB3.   
     
     
         17 . The method of  claim 14 , wherein at least eight of the alleles in the plurality of alleles are selected from the group consisting of:
 (a) allele G of gene DRD1;   (b) allele A1 of gene DRD2;   (c) allele C of gene DRD3;   (d) allele C of gene DRD4;   (e) allele 9R of gene DAT1;   (f) allele 7-11R of gene DRD4;   (g) allele S or L of gene HTTLPR;   (h) allele 4R of gene MAOA;   (i) allele G of gene COMT;   (j) allele G of gene OPRM1; and   (k) allele 181 of gene GABRB3.   
     
     
         18 . The method of  claim 14 , wherein the step of comparatively analyzing comprises utilizing logistic regression modeling. 
     
     
         19 . The method of  claim 14 , wherein the non-allelic risk score is based upon stratification of a reward deficiency syndrome selected from the group consisting of alcohol, psycho-stimulants, marijuana, nicotine, opiates, epigenetic induced altered opiate receptor function, carbohydrates, obesity, gambling, sex addiction, aggression, stress, personality disorders, and novelty seeking, ADHD, Tourette's syndrome, Autism, and combinations thereof.