PANDA: Psilocybin-assisted therapy for treatment of alcohol use disorder and comorbid depression

Psilocybin-Assisted Therapy for Alcohol Use Disorder and Depression This study explores psilocybin-assisted therapy for adults with alcohol use disorder and co-occurring depression. Drug Component Psilocybin will be administered as part of the intervention in a single oral dose during a supervised session. Dose: A single oral dose of 25 mg of psilocybin Administration Mode: Oral capsule Duration: One dosing session Setting: Dosing will occur in a controlled clinical environment with medical oversight, in line with regulatory requirements. Psychological Therapy Component The psilocybin dosing will be integrated into a comprehensive psychological therapy program, which includes both alcohol and drug counselling and psychedelic therapy components (preparation, dosing, and integration sessions). Alcohol and Drug Counselling: Alcohol and drug counselling is a core element of this intervention and involves therapy sessions focused on addressing alcohol use, building coping strategies, and supporting the participant’s mental health. Counsellors are trained professionals with expertise in alcohol and drug treatment. Intervention Procedures and Activities The psilocybin-assisted therapy consists of three main sessions: preparation, dosing, and integration, along with a series of alcohol and drug counselling sessions. Alcohol and Drug Counselling Sessions: Duration: 4 to 6 individual counselling sessions prior to the dosing session. Focus: These sessions address alcohol use and provide psychological support. Topics include understanding the relationship between alcohol and depression, managing cravings, and fostering coping mechanisms for mental health challenges. Preparation Session: Duration: 1 session, approximately 1 to 1.5 hours. Focus: This pre-dosing session prepares participants for the psychedelic experience, including building therapeutic rapport, providing psychoeducation about the psilocybin experience, setting intentions for the session, and addressing any safety concerns. Psilocybin Dosing Session: Duration: 1 session, typically lasting 4 to 6 hours. Focus: During the dosing session, participants will receive a single oral dose of psilocybin under medical supervision in a comfortable, controlled clinical environment. Psychological support will be available throughout the session to ensure the participant’s comfort and safety. Integration Session: Duration: 1 session, approximately 1 to 1.5 hours. Focus: Post-dosing, the integration session helps participants reflect on their experiences and process any insights gained, particularly in relation to alcohol use and depressive symptoms. The goal is to incorporate these insights into daily life. Intervention Delivery and Monitoring Who Delivers the Intervention: Alcohol and Drug Counselling: Delivered by trained therapists with professional qualifications and experience in mental health and alcohol and drug treatment. Psilocybin-assisted Sessions: Facilitated by the alcohol and drug counsellor, alongside a clinician trained in psychedelic-assisted therapy (e.g., clinical psychologist or psychiatrist). Medical Oversight: Provided by qualified medical practitioners during the dosing session. Mode of Delivery: All sessions are face-to-face and conducted individually. Frequency and Total Duration Alcohol and Drug Counselling Sessions: 4 to 6 sessions before the dosing session. Preparation Session: 1 session before the dosing session. Psilocybin Dosing Session: 1 session, typically lasting 4 to 6 hours. Integration Session: 1 session after the dosing session. Total Duration: The intervention spans approximately 4 to 6 weeks, depending on the number of alcohol and drug counselling sessions required. Adherence Monitoring Adherence to the intervention will be monitored through: Regular check-ins with the alcohol and drug counsellor throughout the process to track progress and address any challenges. Documentation of each session’s attendance and content. Post-session assessments to evaluate the participant’s experience and integration of insights gained during the dosing session.