Study of Psilocybin Combined with Non-Invasive Vagus Nerve Stimulation to Enhance Long-Term Memory and Well-Being in Healthy Adults

What this Trial Is About

Researchers are studying whether combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation taVNS, which may boost brain plasticity and memory, can improve the long-term positive effects on behavior compared to psilocybin alone or with sham stimulation. This Phase 1 study involves medically healthy adults with slight decreases in well-being. Participants receive one 25 mg dose of psilocybin with psychological support in a controlled environment lasting several hours. They are randomly assigned to one of four groups receiving different combinations of active or sham taVNS before and after psilocybin dosing, or psychosocial support alone. The taVNS sessions last 20 minutes twice daily for seven days and are performed at home using devices that stimulate the left ear. During the study, participants undergo preparation, a dosing session, and integration sessions after dosing. Researchers collect brain imaging and memory questionnaire data at baseline and eight weeks post-dosing. Mental well-being and adverse events are also monitored throughout. The total study duration includes seven days of taVNS or sham stimulation before and after psilocybin, with follow-up assessments up to eight weeks.

The ENHANCE Study: taVNS and Psilocybin