90 Participants Needed

Psilocybin for Depression and Alcoholism

(PsiloMDDAUD Trial)

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Overseen ByJaydin Hill
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 is testing if psilocybin can help people with both depression and alcohol problems. The drug might improve mood and reduce drinking by changing brain activity. The study involves giving psilocybin to see if it helps. Psilocybin is a naturally occurring psychedelic that has shown promise in treating mood and substance use disorders.

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

You can continue taking SSRIs, SNRIs, and bupropion if you've been stable on them for at least two months before the trial and will remain stable during the study. However, you must stop taking any other antidepressants or medications with a primary serotonergic effect before participating.

Is psilocybin safe for human use?

Psilocybin has been studied in clinical trials and is generally considered safe when used in controlled settings, although it can cause temporary effects like hallucinations and changes in perception. Recent studies have shown promise for its use in treating depression and anxiety, with a good safety profile in healthy adults.12345

How is psilocybin different from other drugs for depression and alcoholism?

Psilocybin is unique because it is a psychedelic drug that can produce rapid and long-lasting effects after just one or a few doses, unlike traditional antidepressants or alcohol treatments that often require daily use. It works by affecting serotonin receptors in the brain, which can lead to changes in mood and perception, and has shown promise in treating depression and alcohol dependence, even in cases where other treatments have failed.678910

What evidence supports the effectiveness of the drug psilocybin for treating depression and alcoholism?

Research shows that psilocybin, found in 'magic mushrooms', has been studied in clinical trials for various psychiatric disorders, including depression and substance use disorders. Initial results are promising, with some patients experiencing significant, long-lasting improvements after just one or a few sessions, although more research is needed to fully understand its benefits.1671112

Who Is on the Research Team?

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Frederick S Barrett, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Adults aged 21-65 with both Major Depressive Disorder and Alcohol Use Disorder, not currently on antidepressants or medications for alcohol dependency. Participants must have a history of depression therapy, limited use of hallucinogens, be medically stable, at low risk for suicide, agree to contraception if applicable, and refrain from certain substances before sessions.

Inclusion Criteria

Have at least a high-school level of education or equivalent (e.g. GED)
I have been diagnosed with Major Depressive Disorder and am currently having a depressive episode.
Have given written informed consent
See 31 more

Exclusion Criteria

Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder
I am currently on medication for depression or alcohol use.
Current or history within one year of meeting DSM-5 criteria for a moderate or severe substance use disorder (excluding caffeine, nicotine, and alcohol)
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single high (25 mg) oral dose of psilocybin or placebo, followed by a Motivational Interviewing intervention for alcohol use

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in depressive symptoms and alcohol use, with assessments at 1 month and 3 months post-treatment

3 months
Multiple visits (in-person and virtual)

Open-label extension

All participants receive a second, unblinded intervention with a single high dose of psilocybin to test the secondary hypothesis

1 day
1 visit (in-person)

Long-term Follow-up

Participants are monitored for long-term effects with follow-up assessments at 6 and 12 months after the second psilocybin administration

12 months
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Placebo
  • Psilocybin
Trial Overview The trial is testing the effectiveness of psilocybin versus a placebo in reducing symptoms of depression and alcohol consumption in patients with co-occurring MDD and AUD. It aims to see if this hallucinogenic drug can help where standard treatments haven't been started or are no longer desired.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Psilocybin TreatmentExperimental Treatment1 Intervention
Participants will be administered 25mg of psilocybin in a clinical setting. Psilocybin is administered orally as a capsule and taken with water.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be administered placebo in a clinical setting. Placebo is administered orally as a capsule taken with water.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Usona Institute

Collaborator

Trials
18
Recruited
1,100+

Published Research Related to This Trial

Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.
The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.
[Treatment with psilocybin: applications for patients with psychiatric disorders].Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]
A meta-analysis of psilocybin studies found that higher doses of psilocybin are associated with stronger subjective experiences, particularly in areas like perceptual alterations and ego dissolution, based on data from standardized questionnaires.
Challenging experiences were less affected by dose, suggesting that individual and environmental factors also play a significant role in the psilocybin experience, indicating that these findings are most relevant in controlled settings rather than recreational use.
Dose-response relationships of psilocybin-induced subjective experiences in humans.Hirschfeld, T., Schmidt, TT.[2022]
Psilocybin, a hallucinogenic compound found in certain mushrooms, has been associated with increasing rates of drug abuse, highlighting the need for comprehensive pharmacological understanding.
Despite its historical use in the 1960s for experimental medical purposes, recent research has only begun to uncover the pharmacological properties of psilocybin, indicating a gap in knowledge that needs to be addressed.
The pharmacology of psilocybin.Passie, T., Seifert, J., Schneider, U., et al.[2016]

Citations

[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]
Dose-response relationships of psilocybin-induced subjective experiences in humans. [2022]
The pharmacology of psilocybin. [2016]
DARK Classics in Chemical Neuroscience: Psilocybin. [2019]
Single-dose psilocybin-assisted therapy in major depressive disorder: A placebo-controlled, double-blind, randomised clinical trial. [2023]
[Hallucinogenic mushrooms]. [2018]
Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. [2022]
A Proposal to Study the Safety and Efficacy of Psilocybe cubensis in Preclinical and Clinical Studies as a Therapeutic Alternative for Major Depressive Disorder. [2023]
Psilocybin as a New Approach to Treat Depression and Anxiety in the Context of Life-Threatening Diseases-A Systematic Review and Meta-Analysis of Clinical Trials. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study. [2022]
Return of the psychedelics: Psilocybin for treatment resistant depression. [2017]
Assessing potential of psilocybin for depressive disorders. [2023]
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