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Psychedelic Therapy

Psilocybin Therapy for Alcoholism (PAP-AUD Trial)

Phase 2
Recruiting
Led By Leah Mayo, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 1-, 4-, and 12-weeks post-dosing
Awards & highlights

PAP-AUD Trial Summary

This trial studies if a single dose of psilocybin combined with therapy can help reduce heavy drinking in people with alcohol addiction.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Psilocybin may cause psychological effects like changes in perception, mood swings, and altered sense of time. It might also lead to physical side effects such as headaches, dizziness, nausea, and increased heart rate.

PAP-AUD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 1-, 4-, and 12-weeks post-dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 1-, 4-, and 12-weeks post-dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heavy drinking
Secondary outcome measures
Abstinence
Alcohol cue reactivity
Anxiety
+7 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

PAP-AUD Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,386 Total Patients Enrolled
5 Trials studying Alcoholism
715 Patients Enrolled for Alcoholism
University of MarylandOTHER
160 Previous Clinical Trials
302,155 Total Patients Enrolled
1 Trials studying Alcoholism
25 Patients Enrolled for Alcoholism
University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,026 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals who have exceeded the age of 20 eligible for this trial?

"This clinical trial has established age limits of 22 years old and 65 years old for potential participants."

Answered by AI

What potential risks are associated with administering a 25mg dose of this drug?

"Our team at Power rated the safety of High Dose (25mg) as a 2, since there is preliminary evidence to suggest it can be administered without risk yet no data that supports its efficacy."

Answered by AI

Are there any opportunities for people to enroll in this research endeavor?

"Information on clinicaltrials.gov denotes that this trial is not currently taking partakers, despite having been originally unveiled on October 1st 2023 and modified as recently as September 18th of the same year. Fortunately, more than 370 other medical trials are still recruiting patients at present."

Answered by AI

Who has the eligibility to take part in this medical trial?

"This research venture is looking for 128 patients suffering from Alcohol Use Disorder (AUD) of moderate to severe intensity. Furthermore, applicants must have had at least 5 heavy drinking bouts in the last month and either 18 or 24 drinks per week depending on gender. Additionally, those seeking enrollment should want to reduce their alcohol intake and have limited lifetime hallucinogen usage (no more than 10 times total with none within 6 months)."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I tried all SSRIs and snris and ssnris as well as tricyclic antidepressants.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder
2024. "Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05995769.
All > Alcoholism
~85 spots leftby Oct 2027
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