Putative targeting of dopamine D2 receptor function in Reward Deficiency Syndrome (RDS) by Synaptamine Complex™ variant (KB220): Clinical trial showing anti-anxiety effects

Since 1990, researchers have proposed that genetic variants of dopaminergic genes and other "reward genes" are important common determinants of Reward Deficiency Syndrome (RDS). RDS refers to the breakdown of a cascade of neurotransmitters in the brain in which one reaction triggers another - the reward cascade - and resultant aberrant conduct. Association studies have amassed strong evidence implicating the D (2) dopamine receptor (DRD2) gene in harmful conditions such as alcoholism, and the DRD2 gene also has been found to be involved in other substance use disorders including cocaine, nicotine, and opioid dependence, as well as obesity. Brain dopamine has been implicated as the so-called " anti-stress molecule." The present study investigated anti-anxiety effects of Synaptamine Complex [KB220], a dopaminergic activator, in a randomized double-blind placebo controlled study in alcoholics and in polydrug abusers attending an in-patient chemical dependency program. In this randomized double-blind placebo controlled study of 62 alcoholic and polydrug abusers, we utilized skin conductance level (SCL) to evaluate stress responses. Patients receiving Synaptamine Complex [KB220] had a significantly reduced stress response as measured by SCL, compared to patients receiving placebo. Two factor ANOVA yielded significant differences as a function of Time (p<0.001), and Treatment (p<0.025) as well as a Time- by-Treatment interaction (p<0.01). The results of this study suggest that the Synaptamine Complex™ [KB220] may improve treatment response in an in-patient treatment setting by reducing stress related behaviors and warrants further investigation.