Psilocybin for Alcoholism

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
AlcoholismPsilocybin - Drug
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study Summary

The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question[s] it aims to answer are: Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy? Is treatment with psilocybin and therapy safe for participants? Participants will Attend 13 study visits Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo Record their daily alcohol consumption on study specific device Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.

Eligible Conditions
  • Alcoholism

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 8 weeks

8 weeks
Reduction in the number of Heavy Drinking Days

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Diphenhydramine
9%Nausea
7%Viral upper resp. tract infection
7%Pain
7%Bronchitis
7%Back pain
4%Suicidal Ideation
4%Diarrhea
4%Depressed mood
4%Influenza
4%Headache
4%Sinus headache
4%Alcohol withdrawal syndrome
4%Depression
4%Insomnia
4%Lower resp. tract congestion
4%Oropharyngeal pain
2%Migraine
2%Oedema
2%Constipation
2%Bronchitis bacterial
2%Hypoesthesia
2%Pyrexia
2%Influenza like Illness
2%Anger
2%Peripheral swelling
2%Mallory-Weiss Syndrom
2%Anemia
2%Thrombocytosis
2%Vomiting
2%Dermatitis contact
2%Eye infection
2%Fungal infection
2%Gingivitis
2%Traumatic lung injury
2%Hyponatremia
2%Arthralgia
2%Musculoskeletal pain
2%Pain in extremity
2%Malignant melanoma
2%Dizziness
2%Sedation
2%Anxiety
2%Restlessness
2%Cough
2%Rhinorrhea
2%Sinus congestion
2%Sexual abuse
2%Arthoscopic surgery
2%Endodontic procedure
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02061293) in the Diphenhydramine ARM group. Side effects include: Nausea with 9%, Viral upper resp. tract infection with 7%, Pain with 7%, Bronchitis with 7%, Back pain with 7%.

Trial Design

2 Treatment Groups

Psilocybin
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

128 Total Participants · 2 Treatment Groups

Primary Treatment: Psilocybin · Has Placebo Group · Phase 2

Psilocybin
Drug
Experimental Group · 1 Intervention: Psilocybin · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~560

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

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

Eligibility Criteria

Age 18 - 70 · All Participants · 3 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Washington33.3%
Wyoming33.3%
District of Columbia33.3%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I've had mixed results with Alcohol cessation programs. I have been reading on Psilocybin studies and think I would be a useful tool. I am highly motivated to achieve total alcohol cessation for the rest of my life and willing to participate with this trial fully."
How many prior treatments have patients received?
2100.0%

How responsive is this trial?

Typically responds via
Email100.0%