This study aims to determine the safety and preliminary efficacy of psilocybin-assisted psychotherapy in improving alcohol-related outcomes among adults with severe alcohol use disorder in a a double-blind, dose-comparison concurrent control, randomized trial. Participants will undergo structured psychotherapy and will be randomized to two psilocybin sessions to receive either a full dose (30mg or 40mg) or low dose (10mg or 15mg).
English speaking adults between ages 18 and 65
Diagnosis of DSM5 AUD, severe
Completion of inpatient withdrawal management (i.e. "detox") for AUD within 90 days of enrollment
Amenable to attending all psychotherapy and study visits at BWH CCI
None
Parallel
Psilocybin
DrugPsilocybin is administered in oral capsule form during two dosing sessions held four weeks apart. Each session occurs in a controlled clinical environment with continuous monitoring by trained study therapists. Participants receive a standardized psychotherapy protocol that includes preparatory sessions before dosing and integration sessions afterward. The randomized dosing schedule includes either 10 mg with optional escalation to 15 mg or 30 mg with optional escalation to 40 mg for the second session. All participants also receive support from a peer recovery coach and are offered ongoing outpatient addiction treatment throughout the study period.
Percent Heavy Drinking Days
Percent Heavy Drinking Days (PHDD) is defined as the percentage of days in which participants engage in heavy drinking, calculated using the Timeline Follow-Back (TLFB) method. Heavy drinking is defined using NIAAA criteria (≥4 drinks/day for women; ≥5 drinks/day for men). PHDD will be analyzed as a continuous outcome to compare change over time between the full-dose and low-dose psilocybin groups.
Adverse effects
We will utilize the Patient-Rated Inventory of Side Effects to assess the frequency and severity of adverse effects.
Cue-Induced Craving Response
Craving intensity elicited by alcohol-related visual cues during a standardized cue-reactivity task as measured using a visual analog scale. The scale is titled Cue induced Craving scale and is measured from 0-10, 0 being Not at all and 10 being extremely craving. A higher score indicates more craving of the substance shown.
Neural Response and Connectivity Changes measured by fMRI
BOLD response in the nucleus accumbens (NAcc) to alcohol-related images during craving.
Percent Days Abstinent
Percentage of days with no alcohol use, based on TLFB.
Drinks Per Drinking Day
Number of standard drinks consumed on days with any drinking, assessed using the Timeline Follow-Back (TLFB) method.
Vital signs
Blood pressure
MEQ30 - Mystical Experience Questionnaire.
The Mystical Experience Questionnaire (MEQ-30) is a 30-item self-report measure assessing the intensity of mystical-type experiences during a psychedelic session. Scores are calculated for Transcendence, Positive Mood, Ineffability, Mystical experience, and as a total score, with each expressed as a percentage of the maximum possible score. Higher percentages indicate more intense and complete mystical experiences.
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