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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Timeline Follow-Back for Alcohol to assess change

Secondary outcome measures

Resting state fMRI

T1rho

Other outcome measures

Feasibility and acceptability of the protocol

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293

Nausea

Pain

Viral upper resp. tract infection

Back pain

Bronchitis

Suicidal Ideation

Oropharyngeal pain

Insomnia

Influenza

Depression

Diarrhea

Headache

Sinus headache

Depressed mood

Lower resp. tract congestion

Alcohol withdrawal syndrome

Restlessness

Fungal infection

Rhinorrhea

Pyrexia

Oedema

Vomiting

Musculoskeletal pain

Hypoesthesia

Peripheral swelling

Thrombocytosis

Eye infection

Constipation

Dermatitis contact

Bronchitis bacterial

Traumatic lung injury

Hyponatremia

Arthralgia

Pain in extremity

Dizziness

Migraine

Sedation

Anger

Anxiety

Cough

Sexual abuse

Sinus congestion

Malignant melanoma

Endodontic procedure

Mallory-Weiss Syndrom

Anemia

Influenza like Illness

Gingivitis

Arthoscopic surgery

100%

80%

60%

40%

20%

Study treatment Arm

Diphenhydramine

Psilocybin

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

~730

0 / 6Eligibility criteria met

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

3 Previous Clinical Trials

640 Total Patients Enrolled

Media Library

Alcoholism Clinical Trial 2023: Ketamine Highlights & Side Effects. Trial Name: NCT05421065 — Phase 2

Frequently Asked Questions

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

Might I be eligible to participate in this clinical experiment?

"To meet the enrollment criteria for this trial, participants must have a diagnosis of alcoholism and be between 25-50 years old. The recruitment goal is to enlist 20 individuals."

Answered by AI

Are there vacancies in this trial for prospective participants?

"According to clinicaltrials.gov, this medical trial is no longer seeking applicants at the present moment. This research project that was initially posted on September 1st 2023 and updated lastly on July 18th 2023 has temporarily ceased its search for volunteers; however, there are 389 additional studies actively recruiting participants right now."

Answered by AI

Does the Psilocybin Group present any potential risks to its users?

"Due to the Phase 2 trial nature of Psilocybin Group (PG), we have assigned it a score of 2 on our safety scale. This reflects that although there is some supportive data for its security, no efficacy has been proven yet."

Answered by AI

Is this experiment extending eligibility to individuals over seventy years of age?

"This particular clinical trial is searching for individuals between the ages of 25 and 50. In contrast, there are 31 trials available to those under 18 years old while 269 exist for seniors above 65."

Answered by AI