Psilocybin-Assisted Therapy for Depression and Alcoholism

BL
EK
Overseen ByEsther Kim
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests psilocybin-assisted therapy to determine its safety and effectiveness for individuals with both major depression and alcohol use disorder. Participants will receive either a psilocybin capsule or a placebo to compare differences in their feelings and adherence to the treatment. It suits those with moderate to severe depression and alcohol issues who are not seeking traditional medications for these conditions. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important early-stage findings.

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking certain medications, including antidepressants, antipsychotics, anti-alcohol/anti-craving medications, and some enzyme inhibitors, at least 2 weeks before starting the trial and for its duration, if your doctor confirms it's safe.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that psilocybin is generally safe for people with major depressive disorder (MDD). One study found that a 25 mg dose of psilocybin, when combined with therapy, helped treat MDD without causing any serious unexpected side effects. Another study demonstrated that psilocybin remained safe and effective for up to five years, with no major problems reported. These findings suggest that psilocybin could be a safe option for people with MDD, especially when used with proper support and guidance.12345

Why do researchers think this study treatment might be promising for depression and alcoholism?

Unlike traditional treatments for depression and alcoholism, which often include antidepressants like SSRIs and addiction medications like naltrexone, psilocybin offers a novel approach through its action on serotonin receptors in the brain. Psilocybin is derived from certain mushrooms, and it is thought to promote new neural connections, potentially leading to more profound and lasting improvements in mental health. Researchers are excited because psilocybin may provide rapid relief from symptoms, sometimes within just a few sessions, compared to the weeks or months required for standard medications. Additionally, the unique experience facilitated by psilocybin-assisted therapy could help individuals gain new perspectives on their mental health challenges, offering a holistic approach that extends beyond mere symptom management.

What evidence suggests that psilocybin-assisted therapy could be effective for depression and alcoholism?

Studies have shown that psilocybin can help reduce symptoms of Major Depressive Disorder (MDD). Research suggests that a 25 mg dose of psilocybin, which participants in this trial may receive, can significantly improve depression symptoms over time. Another study found that psilocybin therapy led to a substantial and lasting decrease in depression. Although the long-term effects are still under investigation, these early results appear promising. Additionally, patients have reported few side effects, indicating it might be a safe option for treating these conditions.13456

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

I am between 18 and 65 years old.
I can read and understand English well enough to comprehend the consent form and study materials.
I am willing to follow all study procedures.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Initial Assessment

Participants are randomized to receive either psilocybin (25 mg) or placebo and undergo initial assessments

1 week
1 visit (in-person)

Treatment

Participants receive psilocybin-assisted therapy (PAT) at five various timepoints

10 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks
8 visits (in-person and virtual)

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

Group I: Psilocybin (25 mg)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials
388
Recruited
84,200+

Citations

Psilocybin, an Effective Treatment for Major Depressive ... - PMC

It was found that every study significantly favoured the use of psilocybin in reducing depressive symptoms, with few side effects.

Psilocybin-assisted Therapy for Comorbid Major ...

The goal of this clinical trial is to determine the safety and efficacy of psilocybin assisted Therapy (PAT) in individuals with comorbid ...

Five-year outcomes of psilocybin-assisted therapy for ...

Psilocybin-assisted therapy (PAT) shows promise in reducing depressive symptoms, but long-term effects are unknown. We aimed to determine the ...

Efficacy and safety of psilocybin in the treatment of Major ...

This meta-analysis supports psilocybin's efficacy in treating MDD, particularly at a 25 mg dose, showing a time-dependent therapeutic effect.

Single-Dose Psilocybin Treatment for Major Depressive ...

Conclusions and Relevance Psilocybin treatment was associated with a clinically significant sustained reduction in depressive symptoms and ...

Efficacy and safety of psilocybin-assisted treatment for major ...

This study sought to examine the efficacy and safety of psilocybin through 12 months in participants with moderate to severe MDD who received psilocybin.