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Psilocybin Therapy for Alcoholism

Phase 2
Recruiting
Led By Hannu Alho, MD
Research Sponsored by Clairvoyant Therapeutics
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 8 weeks
Awards & highlights

Study Summary

This trial tests if psilocybin and therapy reduces alcohol consumption more than placebo and therapy. Participants will attend sessions and record alcohol intake.

Who is the study for?
This trial is for adults with a moderate to severe Alcohol Use Disorder (AUD) who want to cut down or stop drinking. They must be generally healthy, without unstable medical conditions, and have no history of hallucinogen use disorder or significant psychiatric disorders like schizophrenia or bipolar disorder.Check my eligibility
What is being tested?
The study tests if psilocybin-assisted psychotherapy can help reduce alcohol consumption more effectively than placebo-assisted therapy. Participants will attend 13 visits, undergo therapy sessions including two where they'll receive either psilocybin or a placebo, and track their daily alcohol intake.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of psilocybin may include nausea, headache, increased heart rate and blood pressure, dizziness, and psychological effects such as altered perception of time and space.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction in the number of Heavy Drinking Days

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%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Rhinorrhea
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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PsilocybinExperimental Treatment1 Intervention
2 oral doses of 25mg psilocybin capsules
Group II: PlaceboPlacebo Group1 Intervention
2 oral doses of placebo (microcrystalline cellulose) capsules
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?

OptimapharmUNKNOWN
5 Previous Clinical Trials
707 Total Patients Enrolled
Clairvoyant TherapeuticsLead Sponsor
Hannu Alho, MDPrincipal InvestigatorAddiktum Oy

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05646303 — Phase 2
Alcoholism Research Study Groups: Placebo, Psilocybin
Alcoholism Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05646303 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05646303 — Phase 2
Alcoholism Patient Testimony for trial: Trial Name: NCT05646303 — Phase 2

Frequently Asked Questions

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

Is the patient eligibility for this clinical trial confined to individuals above the age of twenty?

"This trial is open to those aged 18-70. There are additionally 34 trials for minors and 249 specialized clinical studies available for adults over 65 years old."

Answered by AI

Has the FDA given its stamp of approval for medicinal Psilocybin?

"A score of 2 was assigned to Psilocybin's safety rating, as it is currently in Phase 2 trials and there is evidence for its precautionary properties but none showcasing efficacy."

Answered by AI

Does this research endeavor currently accept new participants?

"As indicated by information on clinicaltrials.gov, recruitment for this medical trial is ongoing. It was initially posted in November 2nd 2022 and the record of it has been revised as recently as December 2nd 2022."

Answered by AI

What is the largest cohort of participants for this research endeavor?

"Correct. According to clinicaltrials.gov, this research trial, which was initiated on November 2nd 2022, is actively seeking participants. 128 individuals need to be sourced from two separate locations."

Answered by AI

Is it possible to take part in this medical trial?

"This medical trial is interested in 128 individuals affected by alcohol use disorder and aged between 18 to 70. The primary inclusion criteria are: a moderate to serious AUD diagnosis as evaluated via DSM-5's Structured Clinical Interview, willingness to reduce or cease drinking totally, and general soundness of health that can be established through physical evaluation, blood tests, ECG testing, urinalysis and toxicology screening."

Answered by AI

Who else is applying?

What state do they live in?
Wyoming
District of Columbia
Alberta
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
2
What site did they apply to?
Sabi Mind
Centre for Addiction and Mental Health
University of British Columbia, Department of Psychiatry Behavioral Reward Affect + Impulsivity Neuroscience Lab (BRAIN Lab)

Why did patients apply to this trial?

After 14 years of trying to even reduce my consumption I have tried numerous times and my consumption is as bad as it was. I consume 12-13 ozs daily. I use it for stress relief. My wife has suggested Magic Mushrooms.
PatientReceived 1 prior treatment
Have been struggling with alcoholism for fifteen years. Been in multiple detox and rehab centers. Tried naltrexone etc. Am told in therapy that there is a trauma element to my addiction. Thanks for your consideration.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. University of British Columbia, Department of Psychiatry Behavioral Reward Affect + Impulsivity Neuroscience Lab (BRAIN Lab): < 48 hours
~0 spots leftby May 2024