Psilocybin for QTc Interval

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Altasciences Clinical Kansas, Inc, Overland Park, KS
QTc Interval
Psilocybin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to evaluate the effects of a supratherapeutic dose of psilocybin on cardiac repolarization.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for QTc Interval

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Up to 30 Days Post Dose

Day 30
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Hour 24
Change from baseline (Day -1) QTcF (ΔΔQTcF) following up to 24 hours post administration of a supratherapeutic dose of psilocybin.

Trial Safety

Safety Progress

1 of 3

Other trials for QTc Interval

Side Effects for

Session #1 Through 1-week Post-session #1 Follow-up
29%Headache
8%Heart rate event
4%Physical discomfort
4%Mild controllable muscle motion
4%Visual distortion
4%Blood pressure event
0%Vivid dreams
0%Chest tightness
0%Altered body sensation
0%Tenseness/soreness
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03181529) in the Session #1 Through 1-week Post-session #1 Follow-up ARM group. Side effects include: Headache with 29%, Heart rate event with 8%, Physical discomfort with 4%, Mild controllable muscle motion with 4%, Visual distortion with 4%.

Trial Design

4 Treatment Groups

Treatment D (Placebo - Positive control)
1 of 4
Treatment A (IP at therapeutic dose)
1 of 4
Treatment B (IP at supratherapeutic dose)
1 of 4
Treatment C (Placebo - Negative control)
1 of 4
Active Control
Experimental Treatment
Non-Treatment Group

36 Total Participants · 4 Treatment Groups

Primary Treatment: Psilocybin · Has Placebo Group · Phase 1

Treatment A (IP at therapeutic dose)
Drug
Experimental Group · 1 Intervention: Psilocybin · Intervention Types: Drug
Treatment B (IP at supratherapeutic dose)
Drug
Experimental Group · 1 Intervention: Psilocybin · Intervention Types: Drug
Treatment C (Placebo - Negative control)
Drug
PlaceboComparator Group · 1 Intervention: Micro-Crystalline Cellulose · Intervention Types: Drug
Treatment D (Placebo - Positive control)
Drug
ActiveComparator Group · 1 Intervention: Moxifloxacin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2018
Completed Phase 2
~590

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days post dose
Closest Location: Altasciences Clinical Kansas, Inc · Overland Park, KS
Photo of kansas 1Photo of kansas 2Photo of kansas 3
2021First Recorded Clinical Trial
1 TrialsResearching QTc Interval
3 CompletedClinical Trials

Who is running the clinical trial?

Usona InstituteLead Sponsor
8 Previous Clinical Trials
441 Total Patients Enrolled
Charles Raison, MDStudy DirectorUsona Institute
13 Previous Clinical Trials
609 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to comply with all study procedures and are available for the duration of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References