Psilocybin for Depression and Alcoholism
(PsiloMDDAUD 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single high (25 mg) oral dose of psilocybin or placebo, followed by a Motivational Interviewing intervention for alcohol use
Follow-up
Participants are monitored for changes in depressive symptoms and alcohol use, with assessments at 1 month and 3 months post-treatment
Open-label extension
All participants receive a second, unblinded intervention with a single high dose of psilocybin to test the secondary hypothesis
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
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Psilocybin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Usona Institute
Collaborator