Psilocybin-Assisted Therapy for Depression and Alcoholism
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to determine the safety and efficacy of psilocybin assisted Therapy (PAT) in individuals with comorbid Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD). The main question it aims to answer is:
\- What is the feasibility and safety of administering PAT in adults with MDD-AUD by evaluating recruitment, retention, tolerability, and safety?
Researchers will compare the psilocybin (25 mg) and placebo groups to see if there are any significant differences in frequency of dropouts or serious adverse events.
Participants will:
* be randomized to receive either psilocybin (25 mg) or placebo
* visit the site (in-person and remotely) for a total of 14 times to complete study tasks
* receive psilocybin-assisted therapy (PAT) at five various timepoints
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with both Major Depressive Disorder and Alcohol Use Disorder, who can read and understand English. They must be healthy enough for the study, able to take oral medication, use effective contraception if capable of becoming pregnant, and not currently seeking standard treatments for their conditions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization and Initial Assessment
Participants are randomized to receive either psilocybin (25 mg) or placebo and undergo initial assessments
Treatment
Participants receive psilocybin-assisted therapy (PAT) at five various timepoints
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Psilocybin
Trial Overview
Researchers are testing psilocybin-assisted therapy (PAT) against a placebo to see its effects on depression and alcoholism. Participants will randomly receive either psilocybin or a placebo during five sessions and attend a total of 14 visits over the course of the study.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participant is administered one oral capsule (25 mg psilocybin) with water.
Participant is administered one oral capsule (0 mg psilocybin) with water.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre for Addiction and Mental Health
Lead Sponsor
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