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Psilocybin for Depression and Alcoholism (PsiloMDDAUD Trial)

Phase 2
Recruiting
Led By Frederick S Barrett, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a confirmed DSM-5 diagnosis of Major Depressive Disorder and currently experiencing a major depressive episode
Have a confirmed DSM-5 diagnosis of Major Depressive Disorder and currently experiencing a major depressive episode.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week, 1 month, and 3 month post-drug-session visits; 6 and 12 month follow-ups after the second experimental drug administration session
Awards & highlights

PsiloMDDAUD Trial Summary

This trial will test whether psilocybin can help people with co-occurring depression and alcoholism by reducing depressive symptoms and amount of drinking.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Psilocybin may cause temporary changes in perception, sense of time and space, increased heart rate, nausea, headache, dizziness. Psychological effects include anxiety or distress during the experience (often referred to as a 'bad trip').

PsiloMDDAUD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Major Depressive Disorder and am currently having a depressive episode.
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I have been diagnosed with Major Depressive Disorder and am currently having a depressive episode.
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I am between 21 and 65 years old.
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I haven't taken antidepressants for 2 weeks, or 4 weeks if it was fluoxetine.
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I agree not to take any over-the-counter meds, supplements, or herbs before drug sessions unless approved.
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I have been in stable psychotherapy for at least 2 months.
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I have been diagnosed with Major Depressive Disorder and am currently having a depressive episode.
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My health is stable as confirmed by recent medical exams and tests.
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I've tried treatments for depression or alcohol use but don't want standard drugs now.
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I am between 21 and 65 years old.
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I am between 21 and 65 years old.
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I haven't taken antidepressants for at least 2 weeks, or 4 weeks for fluoxetine.
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I am between 21 and 65 years old.
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I agree not to take medications like Viagra within 72 hours of each treatment.
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I have been diagnosed with Major Depressive Disorder and am currently having a depressive episode.
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I have tried treatments for depression or alcohol use but don't want standard medication now.

PsiloMDDAUD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 week, 1 month, and 3 month post-drug-session visits; 6 and 12 month follow-ups after the second experimental drug administration session
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 week, 1 month, and 3 month post-drug-session visits; 6 and 12 month follow-ups after the second experimental drug administration session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in gamma-glutamyl transferase (GGT)
Change from baseline in grid-version of the Hamilton Depression Rating Scale (GRID-HAMD) score
Change from baseline in percentage of days abstinent as measured by the Time Line Follow Back (TLFB) assessment
+2 more
Secondary outcome measures
Change from baseline in %CDT
Change from baseline in AST/ALT ratio
Change from baseline in GGT
+4 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
44%
Headache
21%
Nausea
15%
Anxiety
8%
Suicidal Ideation
6%
Insomnia
6%
Depressed mood
4%
Abdominal pain upper
4%
Vomiting
4%
Corona virus infection
4%
Upper respiratory tract infection
4%
Viral upper resp. tract infection
4%
Alcohol poisoning
4%
Depression
4%
Pneumonia
2%
Urinary incontinence
2%
Illusion
2%
Biopsy cervix
2%
Palpitations
2%
Cataract
2%
Abdominal pain
2%
Toothache
2%
Pain
2%
Limb injury
2%
Muscle strain
2%
Blood pressure diastolic increased
2%
Blood pressure increased
2%
Back pain
2%
Musculoskeletal pain
2%
Myalgia
2%
Dizziness
2%
Psychomotor hyperactivity
2%
Alcohol withdrawal syndrome
2%
Dysphoria
2%
Testicular pain
2%
Hyperventilation
2%
Food poisoning
2%
Food allergy
2%
Dyspepsia
2%
Influenza
2%
Nasal congestion
2%
Skin cosmetic procedure
2%
Photopsia
2%
Diverticulitis
2%
Asthenia
2%
Fatigue
2%
Gingivitis
2%
Dyspnea
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Psilocybin
Diphenhydramine

PsiloMDDAUD Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,245 Previous Clinical Trials
14,816,016 Total Patients Enrolled
56 Trials studying Depression
29,485 Patients Enrolled for Depression
Frederick S Barrett, PhDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
43 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04620759 — Phase 2
Depression Research Study Groups: Psilocybin Treatment, Placebo
Depression Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04620759 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04620759 — Phase 2
Depression Patient Testimony for trial: Trial Name: NCT04620759 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What security measures are in place to ensure the safe usage of Psilocybin?

"Given the Phase 2 nature of this trial, with some indication of safety but no evidence for efficacy, our team has assessed its safety as a score of 2."

Answered by AI

What are the primary objectives of this scientific endeavor?

"This trial's primary goal, which will be monitored at Baseline and 3 months post-intervention is to evaluate the change in days of sobriety as measured through Time Line Follow Back assessments. Secondary objectives involve evaluating changes from baseline in %CDT (measured via blood tests), State Trait Anxiety Index scores, and percentage of abstinent days (gauged by TLFB)."

Answered by AI

Is enrollment available for this research project?

"Clinicaltrials.gov confirms that this trial is actively enrolling; it was initially listed on April 14th 2021 and has been most recently revised on August 29th 2022."

Answered by AI

How many individuals are engaging in this experiment?

"Affirmative. Clinicaltrials.gov hosts data which confirms that the recruitment phase of this clinical trial is currently underway, having started on April 14th 2021 and updated most recently on August 29th 2022. The study requires 90 participants to be collected from one medical site."

Answered by AI

Does the trial's eligibility criteria include individuals under forty years of age?

"The lower limit for patient recruitment is 21 years old, whilst the upper threshold stands at 65."

Answered by AI

What other research initiatives have been conducted utilizing Psilocybin?

"As it stands, 32 clinical trials for psilocybin are ongoing. Unfortunately, none of these live studies are in Phase 3 yet. Vancouver Washington has the most study sites with 35 locations running experiments on this treatment."

Answered by AI

May I be included in the experiment?

"The eligibility criteria for participation in this clinical trial entails a diagnosis of melancholia and being between 21-65 years old. At the moment, approximately 90 individuals are needed to join."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Virginia
Maryland
Other
How old are they?
65+
18 - 65
What site did they apply to?
Johns Hopkins Center for Psychedelic and Consciousness Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0

What questions have other patients asked about this trial?

When will I know? Is there financial aide? When does the trial take place?
PatientReceived no prior treatments
How long does the initial meeting last? Is the treatment daily? How many weeks or months will the trial last?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Substance abuse program twice. I have seen people have good outcomes for various issues after taking psilocybin.
PatientReceived 2+ prior treatments
Prescription drugs haven't worked for me. Depression affecting work and life. Psilocybin research is promising.
PatientReceived no prior treatments
I’ve suffered with mental illness and addiction since I was 15. I know no other life. And it’s not a happy one. I would love a cure.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Johns Hopkins Center for Psychedelic and Consciousness Research: < 48 hours
Average response time
  • < 2 Days
~29 spots leftby Aug 2025