128 Participants Needed

Psilocybin Therapy for Alcoholism

(PAP-AUD Trial)

KO
Overseen ByKaitlin O'Grady
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug psilocybin for treating alcoholism?

Research shows that psilocybin has been studied in clinical trials for various psychiatric disorders, including substance use disorders, and has shown promise with marked, long-term improvements in some patients. It is well tolerated with limited side effects, suggesting potential effectiveness for treating alcoholism.12345

Is psilocybin generally safe for human use?

Psilocybin has been studied in healthy adults with escalating doses, showing a safety profile that supports its use under controlled conditions. However, caution is advised for individuals with cardiovascular issues, as its safety in such conditions is not fully known.34678

How is psilocybin therapy different from other treatments for alcoholism?

Psilocybin therapy is unique because it involves the use of a psychedelic compound found in certain mushrooms, which can lead to significant improvements in alcohol dependence after just one or two sessions. Unlike traditional treatments, psilocybin works by affecting serotonin receptors in the brain, potentially offering long-term benefits with minimal side effects.1491011

What is the purpose of this trial?

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).

Research Team

LM

Leah Mayo, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for adults who want to cut down on heavy drinking, meet the criteria for a moderate or severe alcohol use disorder, and have had multiple heavy drinking days recently. They should not be frequent users of hallucinogens, pregnant, or trying to become pregnant. People with certain mental health conditions or serious substance abuse issues other than alcohol are not eligible.

Inclusion Criteria

Limited lifetime hallucinogen use (less than 10 times total, none in past 6 months)
At least 5 heavy drinking days in past 30 days
I have consumed 24 or more drinks weekly in the last month.
See 3 more

Exclusion Criteria

I have been diagnosed with schizophrenia or bipolar disorder, or have a close family member who has.
I have not had serious thoughts or attempts of suicide in the last 3 years.
Currently pregnant, nursing, or trying to become pregnant
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete clinical, behavioral, and neuroimaging measures

1 week

Treatment

Single dose of psilocybin administered followed by 5 weekly MET sessions

5 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
3 visits (in-person) at 1-, 4-, and 12-weeks post-dosing

Treatment Details

Interventions

  • Psilocybin
Trial Overview The study is testing whether a single dose of psilocybin combined with motivational enhancement therapy can help reduce excessive alcohol consumption in individuals diagnosed with an alcohol use disorder.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: High Dose (25mg)Experimental Treatment1 Intervention
PEX010 (Oral Psilocybin), 25mg; single dose administered 24hrs prior to first of 5 weekly MET sessions
Group II: Low dose (1mg)Active Control1 Intervention
PEX010 (Oral Psilocybin), 1mg; single dose administered 24hrs prior to first of 5 weekly MET sessions

Psilocybin is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Psilocybin for:
  • Treatment-resistant depression (TRD) under Breakthrough Therapy designation
🇪🇺
Approved in European Union as Psilocybin for:
  • Treatment-resistant depression (TRD) under PRIME designation

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

University of Maryland

Collaborator

Trials
171
Recruited
325,000+

Johns Hopkins University

Collaborator

Trials
2,366
Recruited
15,160,000+

Bloom Psychedelic Therapy and Research Institute

Collaborator

Trials
1
Recruited
130+

Findings from Research

Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.
The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.
[Treatment with psilocybin: applications for patients with psychiatric disorders].Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]
A meta-analysis of psilocybin studies found that higher doses of psilocybin are associated with stronger subjective experiences, particularly in areas like perceptual alterations and ego dissolution, based on data from standardized questionnaires.
Challenging experiences were less affected by dose, suggesting that individual and environmental factors also play a significant role in the psilocybin experience, indicating that these findings are most relevant in controlled settings rather than recreational use.
Dose-response relationships of psilocybin-induced subjective experiences in humans.Hirschfeld, T., Schmidt, TT.[2022]
In a study involving 12 healthy adults, escalating doses of psilocybin (0.3, 0.45, and 0.6 mg/kg) were administered safely, with no serious adverse events reported, indicating a favorable safety profile for this psychedelic compound.
The pharmacokinetics of psilocin, the active metabolite of psilocybin, were linear across the tested doses, with an elimination half-life of about 3 hours, suggesting that no dose adjustments are necessary for individuals with mild to moderate renal impairment.
Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults.Brown, RT., Nicholas, CR., Cozzi, NV., et al.[2022]

References

[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]
Dose-response relationships of psilocybin-induced subjective experiences in humans. [2022]
Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. [2022]
The pharmacology of psilocybin. [2016]
Psilocybin in Palliative Care: An Update. [2023]
Intravenous mushroom poisoning. [2019]
[Hallucinogenic mushrooms]. [2018]
Effects and safety of Psilocybe cubensis and Panaeolus cyanescens magic mushroom extracts on endothelin-1-induced hypertrophy and cell injury in cardiomyocytes. [2021]
Psilocybin Therapeutic Research: The Present and Future Paradigm. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Psilocybin in neuropsychiatry: a review of its pharmacology, safety, and efficacy. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Psilocybin-assisted treatment for alcohol dependence: a proof-of-concept study. [2022]
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