WP2 - Target-OXY

Effectiveness of oxytocin in a unique DSM-5-based rat model of alcohol addiction: Preclinical Phase II Study: Partner OXY III

Of all diseases, those caused by alcohol use represent the world's largest share. Treatment options and available pharmacotherapeutic agents have only limited effectiveness. The need to find new, more effective treatment options is very high. Unfortunately, many of the candidates tested promisingly in animal experiments have so far failed to convince in human patients. The reason for this may be the lack of robustness of preclinical data. In fact, only very few preclinical studies report randomization, blinding, or sufficient sample size calculations. The clinical diagnosis of alcohol addiction is based on DSM-5 criteria. Therefore, it is necessary to work with an animal model, which is also assessable according to these criteria. In this project, the clinical applicability of oxytocin as an anti-relapse medication for alcohol addiction will be studied. To investigate the clinical applicability of oxytocin, a new module in drug development is being introduced for the first time, a preclinical multi-center placebo-controlled trial. This subproject is one of the three study centers to investigate the effectiveness of intranasally administered oxytocin in a unique DSM-5-based rat model of alcohol addiction. New computational approaches will make it possible to detect early warning signs and drinking patterns indicating relapse, as well as those individuals who respond to oxytocin treatment. If successful, not only alcohol addicted patients may benefit from new pharmacotherapy, but the novel form of this preclinical study can serve as a blueprint for many other scientific studies to explore potential treatments for brain function disorders in a time and cost saving way.

Keywords: Alcohol addiction, Oxytocin