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Psilocybin for Depression and Alcoholism (PsiloMDDAUD Trial)
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.
PsiloMDDAUD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPsiloMDDAUD Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 95 Patients • NCT02061293PsiloMDDAUD Trial Design
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- You must be able to speak English fluently.I have been diagnosed with Major Depressive Disorder and am currently having a depressive episode.I am currently on medication for depression or alcohol use.I have been in stable psychotherapy for at least 2 months.A close family member has schizophrenia or a similar condition.I have been diagnosed with Major Depressive Disorder and am currently having a depressive episode.You have given informed consent.I agree not to take any erectile dysfunction medication 72 hours before each treatment.I've tried treatments for depression or alcohol use but don't want standard drugs now.I am between 21 and 65 years old.I haven't taken antidepressants for at least 2 weeks, or 4 weeks if it was fluoxetine.I am not pregnant, nursing, or at risk of becoming pregnant due to ineffective contraception.I take prescribed mental health medication daily.I haven't taken antidepressants for 2 weeks, or 4 weeks if it was fluoxetine.I regularly take medication that affects serotonin in the brain.I smoke or use nicotine equivalent to more than 10 cigarettes daily.I agree not to take any over-the-counter meds, supplements, or herbs before drug sessions unless approved.Electroconvulsive therapy didn't improve my current depression.I have been in stable psychotherapy for at least 2 months.I have tried treatments for depression or alcohol use but don't want standard medication now.I have not had serious heart issues or strokes in the past year.I have been diagnosed with Major Depressive Disorder and am currently having a depressive episode.I have epilepsy with a history of seizures.My health is stable as confirmed by recent medical exams and tests.I am medically stable based on recent health screenings and tests.I agree not to take any non-prescribed drugs or supplements before each drug session, except for approved exceptions.I have been in stable psychotherapy for at least 2 months.I agree not to take any non-prescribed drugs or supplements before each drug session, except for approved exceptions.I use insulin for my diabetes and haven't had low blood sugar with pills.I haven't taken antidepressants for 2 weeks, or 4 weeks if it was fluoxetine.You have a baseline GRID-HAMD score ≥ 18.You have consumed alcohol heavily at least 2 days per month in the past 3 months.My health is stable according to recent medical exams and tests.I've tried treatments for depression or alcohol use but don't want standard drugs now.I am between 21 and 65 years old.I am between 21 and 65 years old.You have been diagnosed with Alcohol Use Disorder according to a specific set of guidelines called the DSM-5.I haven't taken antidepressants for at least 2 weeks, or 4 weeks for fluoxetine.You have consumed a lot of alcohol at least twice a month in the last 3 months.You cannot use any drugs that affect your mood, except for caffeine, within 24 hours of taking the study drug.You are judged by study team clinicians to be at low risk for suicide.You have been diagnosed with Alcohol Use Disorder according to the DSM-5 guidelines.I am between 21 and 65 years old.I agree not to take medications like Viagra within 72 hours of each treatment.I have been diagnosed with Major Depressive Disorder and am currently having a depressive episode.You have had at least 4 days in the past 90 days where you didn't drink any alcohol.You have been diagnosed with Alcohol Use Disorder according to the DSM-5 guidelines.You have only used hallucinogenic drugs a few times in your life, and it has been at least 5 years since your last use.I agree not to take medications like Viagra within 72 hours of each treatment.You must have had at least four days without drinking alcohol in the last three months.You have used hallucinogens for a limited time in your life. It is preferred that you have not used them in the past 5 years or have used them less than 10 times in total.I have tried treatments for depression or alcohol use but don't want standard medication now.
- Group 1: Psilocybin Treatment
- Group 2: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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)."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Johns Hopkins Center for Psychedelic and Consciousness Research: < 48 hours
Average response time
- < 2 Days
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