NCT05995769 Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder
| NCT ID | NCT05995769 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Calgary |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2024-03-20 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 128 participants in total. It began in 2024-03-20 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Leah Mayo, PhD
PRINCIPAL INVESTIGATOR
University of Calgary
Frequently Asked Questions
Who can join the NCT05995769 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 65 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05995769 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05995769 currently recruiting?
Yes, NCT05995769 is actively recruiting participants. Contact the research team at pactlab@ucalgary.ca for enrollment information.
Where is the NCT05995769 trial being conducted?
This trial is being conducted at Calgary, Canada.
Who is sponsoring the NCT05995769 clinical trial?
NCT05995769 is sponsored by University of Calgary. The principal investigator is Leah Mayo, PhD at University of Calgary. The trial plans to enroll 128 participants.