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New treatment option for Alcohol Use Disorder
Official title Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder
ClinicalTrials.gov ID: NCT05995769
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as an once-weekly, being studied as a potential treatment for alcohol use disorder.
Also referred to as magic mushrooms, PEX010.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol use disorder (AUD).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65
You may be able to join if
- Meets DSM-5 AUD criteria of at least moderate severity
- Meets heavy drinking requirements (heavy drinking days, number of drinks) in past 30 days
- Desire to decrease alcohol consumption
- Limited lifetime hallucinogen use
You likely can't join if
- Severe or moderate substance use disorder other than alcohol or nicotine in past 6 months
- Diagnosis of schizophrenia, bipolar disorders or first-degree relative with diagnosis
- Active suicidal ideation or serious attempt within past 3 years
- Currently pregnant, nursing, or trying to become pregnant
- Any notable abnormality on ECG, physical exam, or routine medical blood laboratory test
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.