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Psilocybin for Long QT Syndrome

Phase 1

Waitlist Available

Research Sponsored by Usona Institute

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 up to 30 days post dose

Awards & highlights

Study Summary

This trial will test whether psilocybin affects heart rate.

Eligible Conditions

Long QT Syndrome
Pharmacokinetics

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days post dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days post dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post dose for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Part 1: Change from baseline (Day -1) QTcF (ΔΔQTcF) following up to 24 hours post administration of a supratherapeutic dose of psilocybin.

Part 2: Change from baseline (T=0 hours) of AUC of psilocybin and its metabolite psilocin following up to 24 hours post administration of a therapeutic dose of psilocybin under fed and fasted conditions.

Part 2: Change from baseline (T=0 hours) of Cmax of psilocybin and its metabolite psilocin following up to 24 hours post administration of a therapeutic dose of psilocybin under fed and fasted conditions.

+1 more

Secondary outcome measures

Part 1: Number of participants with Treatment-Related Adverse Events as assessed by CTCAE v4.0.

Part 2: Number of participants with Treatment-Related Adverse Events as assessed by CTCAE v4.0

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

Pyrexia

Hypoesthesia

Oedema

Fungal infection

Vomiting

Rhinorrhea

Musculoskeletal pain

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

6Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Part 2: IP at Therapeutic Dose (Fed Conditions)Experimental Treatment1 Intervention

A single therapeutic dose of psilocybin under fed conditions.

Group II: Part 2: IP at Therapeutic Dose (Fasted Conditions)Experimental Treatment1 Intervention

A single therapeutic dose of psilocybin administered under fasted conditions.

Group III: Part 1: Treatment B (IP at Supratherapeutic Dose)Experimental Treatment1 Intervention

A single supratherapeutic dose of psilocybin.

Group IV: Part 1: Treatment A (IP at Therapeutic Dose)Experimental Treatment1 Intervention

A single therapeutic dose of psilocybin.

Group V: Part 1: Treatment D (Placebo - Positive Control)Active Control1 Intervention

A single 400 mg dose of moxifloxacin.

Group VI: Part 1: Treatment C (Placebo - Negative Control)Placebo Group1 Intervention

A single dose of placebo-to-match psilocybin MCC capsules.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin

2021

Completed Phase 2

~730

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Usona InstituteLead Sponsor

12 Previous Clinical Trials

698 Total Patients Enrolled

Charles Raison, MDStudy DirectorUsona Institute

15 Previous Clinical Trials

732 Total Patients Enrolled

Frequently Asked Questions

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

To what extent can taking Psilocybin be hazardous to patients?

"The safety of Psilocybin is currently rated a 1, as this trial only just entered the initial Phase 1 testing, wherein clinical data on efficacy and safeguarding measures are limited."

Answered by AI

Are applicants under the age of 30 eligible for admission to this research endeavor?

"According to the trial's guidelines, individuals aged 18-65 are eligible for enrollment in this experiment."

Answered by AI

Is the trial currently recruiting participants?

"At present, the clinical trial is not enrolling patients. Data hosted on clinicaltrials.gov indicates that this study was posted June 22nd 2022 and last amended November 29th 2022. However, there are 1 other medical studies actively recruiting individuals at this time."

Answered by AI

Could I partake in this medical trial?

"Participants aged between 18 and 65 with a documented qtc interval may apply for this 36-person trial. Applicants must provide a signed ICF, identify as either male or female, commit to the duration of the study and demonstrate general healthiness."

Answered by AI