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Dissociative Anesthetic

Psilocybin vs Ketamine Psychotherapy for Alcoholism

Phase 2
Recruiting
Led By Peggy C Nopoulos, MD
Research Sponsored by Peggy C Nopoulos
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No seizure disorder, coronary artery disease, heart failure, uncontrolled hypertension, insulin-dependent diabetes
No history of cerebrovascular accident, asthma, or significant alcohol withdrawal history
Must not have
Medical assessment that yields: serious ECG abnormalities (evidence of ischemia, myocardial infarction, QTc prolongation [QTc > .045]), serious abnormalities of complete blood count or chemistries, medical conditions that would preclude safe participation (significantly impaired liver function)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effects of two types of psychotherapy (psilocybin & ketamine) on people with alcohol addiction.

Who is the study for?
This trial is for adults with moderate to severe Alcohol Use Disorder who've had multiple heavy drinking days recently, are not in formal alcohol treatment, and have no serious health issues like heart disease or uncontrolled diabetes. Participants must be fluent in English, psilocybin and ketamine naive, without a history of certain mental health conditions.
What is being tested?
The study compares the effects of two types of assisted psychotherapy: one using psilocybin and the other using ketamine. It aims to see which helps more with alcohol use disorder by measuring changes in participants' drinking behavior.
What are the potential side effects?
Possible side effects from psilocybin or ketamine may include nausea, headaches, increased heart rate, blood pressure changes, anxiety or panic reactions during treatment sessions. Long-term psychological effects are also being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have seizures, heart disease, uncontrolled high blood pressure, or insulin-dependent diabetes.
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I have never had a stroke, asthma, or severe alcohol withdrawal.
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I am male.
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My weight is between 50kg and 150kg.
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I have not had a serious head injury in the last 2 years.
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I have never used psilocybin or ketamine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart, blood, and liver tests do not show serious problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Timeline Follow-Back for Alcohol to assess change
Secondary study objectives
Resting state fMRI
T1rho
Other study objectives
Feasibility and acceptability of the protocol

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%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Psilocybin Group (Arm 1)Experimental Treatment1 Intervention
receives individual psychotherapy sessions plus a (25 mg) psilocybin session.
Group II: Ketamine Group (Arm 2)Active Control1 Intervention
receives individual psychotherapy sessions plus a (200 mg) ketamine session with open-label access option at the end of their study involvement.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

Peggy C NopoulosLead Sponsor
1 Previous Clinical Trials
400 Total Patients Enrolled
Peggy C Nopoulos, MDPrincipal InvestigatorUniversity of Iowa
4 Previous Clinical Trials
720 Total Patients Enrolled
1 Trials studying Alcoholism
80 Patients Enrolled for Alcoholism

Media Library

Alcoholism Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT05421065 — Phase 2
~0 spots leftby Jan 2025
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