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Psychedelic

Psilocybin for PTSD

Phase 2
Recruiting
Led By Alan K Davis, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 21 to 64 years old
Have a current DSM-5 diagnosis of Post-Traumatic Stress Disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to primary endpoint (1 month post psilocybin session 2)
Awards & highlights

Study Summary

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

Who is the study for?
This trial is for US military Veterans aged 21-64 with PTSD, who have a high school education or equivalent and are medically stable. They must not be on antidepressants, have a significant history of drug abuse, severe mental health conditions like schizophrenia or bipolar disorder, cardiovascular issues, diabetes, obesity, or epilepsy.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of psilocybin-assisted therapy in treating PTSD in veterans. Psilocybin is given under controlled conditions to see if it helps reduce PTSD symptoms more than standard treatments.See study design
What are the potential side effects?
Psilocybin can cause headaches, nausea, dizziness, increased heart rate and blood pressure changes. Some may experience anxiety or confusion during treatment sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 64 years old.
Select...
I have been diagnosed with PTSD.
Select...
I have not taken antidepressants before joining.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to primary endpoint (1 month post psilocybin session 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to primary endpoint (1 month post psilocybin session 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Columbia Suicide Severity Rating Scale (C-SSRS)
Therapy, Computer-Assisted
Secondary outcome measures
Post-Traumatic Stress Disorder
PTSD Symptom Severity as measured by the Clinician Administered PTSD Scale-5 (CAPS-5)

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%
Insomnia
4%
Suicidal Ideation
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Peripheral swelling
2%
Pyrexia
2%
Thrombocytosis
2%
Constipation
2%
Oedema
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%
Dizziness
2%
Hypoesthesia
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Rhinorrhea
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Vomiting
2%
Influenza like Illness
2%
Gingivitis
2%
Restlessness
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Trial Design

1Treatment groups
Experimental Treatment
Group I: Psilocybin-assisted therapyExperimental Treatment1 Intervention
Participants will receive two doses of psilocybin, approximately 2 weeks apart, in conjunction with preparatory and post-psilocybin therapy sessions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
823 Previous Clinical Trials
501,228 Total Patients Enrolled
Alan K Davis, PhDPrincipal InvestigatorOhio State University

Media Library

Psilocybin (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05554094 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Psilocybin-assisted therapy
Post-Traumatic Stress Disorder Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05554094 — Phase 2
Psilocybin (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05554094 — Phase 2
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05554094 — Phase 2

Frequently Asked Questions

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

Is participation in this clinical study confined to individuals aged 75 and under?

"Prospective participants of this trial must be between the ages 21 and 64. For those younger or elder, there are 365 trials available to minors and 1033 options that cater to patients above the age of 65."

Answered by AI

Are there still opportunities to enroll in this clinical research endeavor?

"Clinicaltrials.gov indicates that this medical study, which began recruiting on January 1st 2023 and last updated its records on September 21st 2022 is not presently searching for participants. However, there are currently 1504 other clinical trials actively seeking candidates at the moment."

Answered by AI

Is it possible for me to be a participant in this trial?

"This research seeks to recruit 15 individuals, aged 21-64, who have suffered moral injury and fulfill the following requirements: no antidepressant treatment history prior to enrollment; minimal risk of suicidal behaviour as judged by the study clinicians; veteran status within the US military; high school education or equivalent; current DSM-5 diagnosis of Post-Traumatic Stress Disorder (PTSD); CAPS-5 total severity score ≥35 at baseline assessment point; medically stable condition; limited lifetime experience with hallucinogens; and general medical health."

Answered by AI

To what extent is Psilocybin-assisted therapy hazardous for individuals?

"Considering the current dataset, our team at Power gave Psilocybin-assisted therapy a score of 2 out of 3. This is due to Phase 2 trial data which suggests that there are some safety measures in place but no efficacy evidence yet available."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
Florida
Other
Ohio
How old are they?
18 - 65
What site did they apply to?
Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
3+
0

What questions have other patients asked about this trial?

How long would I actually have to be in Ohio? Could any of the screening or follow up be virtual?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I want to explore what psilocybin can do for my PTSD. I would like to help advance research for psilocybin for mental health conditions.
PatientReceived 2+ prior treatments
Looking for treatment to help me get back to my normal life again. I’m not a veteran.
PatientReceived 2+ prior treatments
I have been seeking treatments to help treat my PTSD symptoms and am curious to potentially try psilocybin to help with that.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
~6 spots leftby Jan 2025