1Department of Psychiatry and Psychotherapy, University of Magdeburg, Germany
The idea of DBS arose from an accidental finding in a patient with anxiety disorder, whose secondary addiction vanished after DBS of the Nucleus accumbens (NAc) was tried to treat his anxiety (Kuhn et al, 2007). It was hypothesized that DBS of the NAc will stop craving for alcohol and therefore erase one of the reasons for relapse. In the last 10 years, almost 20 patients received DBS of the nucleus accumbens (NAc) as a potential treatment of their long-lasting severe alcohol addiction. Initially, individual patients were selected for a pilot trial (Mueller et al, 2009, 2016). Although only 5 patients were included, the results seemed promising and convinced the German Research Foundation to fund a sham-controlled multicenter clinical trial (DeBraSTRA – deep brain stimulation in treatment resistant alcoholism) which started recruiting patients in 2013. Unforeseen, recruitment into the trial was much more difficult than expected and until the end of 2015, only 12 patients could be recruited. Therefore, recruitment into the trial as well as funding by the DFG was paused.
In the first part, the talk will summarize the clinical outcome of the pilot trial and present unblinded clinical data from the sham-controlled phase of the multicenter DeBraSTRA trial.
In the second part, the talk will try to identify reasons, why – despite the urge for novel treatment options – recruitment into clinical trials of DBS in addiction seems to be difficult. These include challenges based on clinical inclusion and exclusion criteria, behavioral aspects of the disease as well as ethical and regulatory criteria by authorities.