Psilocybin-assisted therapy for Moral Injury

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Moral Injury+7 More
Psilocybin - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether psilocybin can help treat PTSD in military veterans.

Video Summary

Eligible Conditions
  • Moral Injury
  • Post Traumatic Stress Disorder (PTSD)
  • Trauma and Stressor Related Disorders
  • Mental disorders
  • Stress Disorders, Traumatic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Moral Injury

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Baseline to Primary Endpoint (1 month post psilocybin session 2)

Month 1
Columbia Suicide Severity Rating Scale (C-SSRS)
Post-Traumatic Stress Disorder
PTSD Symptom Severity as measured by the Clinician Administered PTSD Scale-5 (CAPS-5)
Therapy, Computer-Assisted

Trial Safety

Safety Progress

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

Other trials for Moral Injury

Side Effects for

Psilocybin
44%Headache
21%Nausea
15%Anxiety
8%Suicidal Ideation
6%Insomnia
6%Depressed mood
4%Alcohol poisoning
4%Pneumonia
4%Viral upper resp. tract infection
4%Depression
4%Corona virus infection
4%Vomiting
4%Upper respiratory tract infection
4%Abdominal pain upper
2%Musculoskeletal pain
2%Dizziness
2%Pain
2%Limb injury
2%Abdominal pain
2%Blood pressure increased
2%Urinary incontinence
2%Cataract
2%Testicular pain
2%Toothache
2%Illusion
2%Fatigue
2%Psychomotor hyperactivity
2%Skin cosmetic procedure
2%Food allergy
2%Muscle strain
2%Back pain
2%Food poisoning
2%Alcohol withdrawal syndrome
2%Dysphoria
2%Nasal congestion
2%Photopsia
2%Myalgia
2%Palpitations
2%Dyspepsia
2%Biopsy cervix
2%Gingivitis
2%Diverticulitis
2%Asthenia
2%Influenza
2%Oropharyngeal pain
2%Hyperventilation
2%Blood pressure diastolic increased
2%Dyspnea
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02061293) in the Psilocybin ARM group. Side effects include: Headache with 44%, Nausea with 21%, Anxiety with 15%, Suicidal Ideation with 8%, Insomnia with 6%.

Trial Design

1 Treatment Group

Psilocybin-assisted therapy
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Psilocybin-assisted therapy · No Placebo Group · Phase 2

Psilocybin-assisted therapy
Drug
Experimental Group · 1 Intervention: Psilocybin · 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

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to primary endpoint (1 month post psilocybin session 2)

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
704 Previous Clinical Trials
382,288 Total Patients Enrolled
Alan K Davis, PhDPrincipal InvestigatorOhio State University

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a US military veteran.\n
You are 21 to 64 years old.
You have at least a high-school level of education or equivalent.
You have a current diagnosis of Post-Traumatic Stress Disorder.
You have a CAPS-5 total severity score of ≥35 at baseline.
You are medically stable.
You have used hallucinogens for less than a lifetime.
You have a general medical condition.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: October 31st, 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.

Who else is applying?

What state do they live in?
Florida50.0%
California50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References