Psilocybin-Assisted Psychotherapy for Severe Alcohol Use Disorder
This study is testing if psilocybin-assisted psychotherapy can help adults with severe alcohol use disorder. You would receive psilocybin (a psychedelic compound) in capsule form during two sessions, four weeks apart, along with therapy. Researchers want to see if this treatment is safe and helps reduce heavy drinking days. They will also look at how it affects cravings and other brain processes. To join, you need to be 18-65 years old, speak English, have a severe alcohol use disorder diagnosis, and have recently completed inpatient detox. The study is currently recruiting 36 participants.
- Study design
- This is a double-blind, randomized trial comparing different doses of psilocybin. Participants will be randomly assigned to receive either a full or low dose of psilocybin.
- What's involved
- You would attend psychotherapy sessions and two psilocybin dosing sessions four weeks apart. There will also be follow-up visits and assessments over 48 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your health and progress will be monitored for 48 weeks after the second psilocybin dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Joji Suzuki, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
Who to contact
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What this trial measures
- Percent Heavy Drinking DaysWeeks 0-24 following the first psilocybin dosing session.
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 effects1, 2, 4, 8, 16, 24 and 48 weeks after receiving the second dose of the psilocybin treatment.
We will utilize the Patient-Rated Inventory of Side Effects to assess the frequency and severity of adverse effects.
- Cue-Induced Craving ResponseMeasured at baseline, 4 and 24 weeks after the second psilocybin treatment.
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 fMRI1 week before and 1 week after the second psilocybin session
BOLD response in the nucleus accumbens (NAcc) to alcohol-related images during craving.
- Neural Response and Connectivity Changes measured by fMRI1 week before and 1 week after the second psilocybin session
BOLD response in the dorsolateral prefrontal cortex (DLPFC) during down-regulation of craving.
- Neural Response and Connectivity Changes measured by fMRI1 week before and 1 week after the second psilocybin session
NAcc-DLPFC functional connectivity during alcohol cue processing.