Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD
This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical imp
| Condition(s) | Alcohol Use Disorder |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a double-blind, randomized, placebo-controlled Phase 2 mechanistic clinical trial designed to evaluate the therapeutic neural mechanisms of psilocybin in patients with alcohol use disorder (AUD), and to determine whether further studies are warranted to study the relationship of any such effects to clinical improvement in AUD symptoms. The primary aims are to evaluate the effects of psilocybin on AUD; measures will include 1) fMRI neural activation and functional connectivity, using a well-validated task to characterize neural and subjective response to negative affective and alcohol visual stimuli; 2) alcohol use data (self-report and blood biomarkers); and 3) self-report measures related the NE, IS, and EF domains. |
| Who can participate | Inclusion Criteria: 1. Are able to provide voluntary informed consent 2. Have a breath alcohol concentration (BrAC) ≤ 0.01% at screening, as determined by a breath alcohol reading from a calibrated breath alcohol sensor. (Note: this criterion may be re-evaluated within the 30-day screening period. This criterion will also be reassessed at Baseline, on Day 0, and on Day 2. Those not meeting the criterion may be rescheduled once within 14 days if the criterion is likely to resolve within 14 days in the judgement of the Investigator). 3. Are able to read, speak, and understand English, as documented during the informed consent process. a. Non-English speaking subjects will be excluded because the study is using only validated English-language versions of assessment instruments. 4. Are 18 to 6 |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | NYU Langone Health |
| Locations | New Canaan, Connecticut, United States; New York, New York, United States |
| Start date | 2025-08-26 |
| NCT ID | NCT06349083 |
| Official listing | https://clinicaltrials.gov/study/NCT06349083 |