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. 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 65 years old, inclusive, at Screeni…
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 four supportive therapy sessions of manual-based treatment from two Center for Psychedelic Medicine (CPM) clinicians. The lead clinician will be a licensed physician, clinical psychologist, or nurse practitioner who will be primarily responsible for the content of the intervention. The second therapist will have at least a master's degree or be pursuing a master's or doctoral degree in a related clinical field.
Location
- NYU Langone HealthNew York, New York