Alcohol Use Disorder study: Psilocybin
Official title Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder
ClinicalTrials.gov ID: NCT05995769
What this study is testing
What is Psilocybin?
This is an investigational medicine being studied to see if it can help reduce heavy drinking in people with alcohol use disorder. It is designed to interact with serotonin receptors in the brain, which may influence mood and perception.
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 study wants to see whether a single psilocybin dose combined with motivational enhancement therapy can lower heavy drinking in patients with alcohol use disorder.
- Who it's for
- Adults who have an alcohol use disorder and are willing to try a new treatment.
- What's involved
- Participants receive one dose of psilocybin in a controlled setting and attend therapy sessions focused on motivation and behavior change.
- Time commitment
- The study lasts a few weeks, with a single drug session and several therapy visits over that period.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Calgary, Alberta, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.