Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for Alcohol Use Disorder
NYU Langone Health
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 docume…
Interventions
- DrugPsilocybin
One 25 mg capsule and one 5 mg capsule (30 mg total) administered once orally
- OtherInactive Placebo
Two matching placebo capsules administered once orally
- BehavioralSupportive therapy sessions
Participants will receive three supportive therapy sessions of manual-based treatment from a Center for Psychedelic Medicine (CPM) clinician, accompanied by a Silver Hill Hospital (SHH) therapist who has an ongoing therapeutic relationship with the participant. The CPM clinician will be a licensed physician, clinical psychologist, or nurse practitioner who will be solely responsible for the content of the intervention. The SHH therapist will provide additional support and continuity with clinical treatment.
Locations (2)
- Silver Hill HospitalNew Canaan, Connecticut
- NYU Langone HealthNew York, New York