Worldwide more than 2 billion people consume alcohol. Nearly 60 million EU citizens engage in harmful drinking and 23 million Europeans are suffering from alcohol addiction. Approved pharmacological treatments for alcoholism are limited in their effectiveness, and new drugs that can be translated into the clinic are warranted. In the last decade, there was considerable enthusiasm that advances in the field of neuroscience would soon translate into mechanistically novel alcohol addiction therapies. However, several new mechanisms that appeared to hold great promise based on preclinical data failed to translate to the human condition. We have created a working group (BMBF funded Project: Psi-Alc) with partners in Switzerland, Italy and France aiming to improve the reliability of preclinical academic research and produce meaningful and translatable results for subsequent cost-intensive Phase II/III testing in alcohol-addicted patients.
There is preliminary evidence for the safety and efficacy of classical psychedelics, such as LSD and psilocybin, in the treatment of alcohol addiction (e.g. Bogenschutz et al.; Grob et al.); however, large-scale randomized controlled trials are missing. We are using a unique rat models for alcohol addiction and have implemented a novel concept of randomized multi-center preclinical phase II testing in laboratory animals. Prior to time-intensive discussions with regulatory bodies, dose determination and finally cost-intensive phase II clinical testing for psilocybin in alcoholics, our Psi-Alc working group is currently assessing the effectiveness and safety of psilocybin in rats for treating alcohol addiction, including a step-wise translation into alcoholic patients.
We will be able to present pilot data on alcohol relapse behavior measured by the alcohol deprivation effect in male and female rats. Final data will guide us to build up a robust preclinical data set for a promising translation to the patient.