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Psychedelic
Psilocybin for Post-Traumatic Stress Disorder
Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center, Columbus, OH
Targeting 5 different conditionsPsilocybinPhase 2RecruitingLed by Alan K Davis, PhDResearch Sponsored by Ohio State UniversityEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have limited lifetime use of hallucinogens
Have a CAPS-5 total severity score of ≥35 at baseline
Must not have
Be younger than 18 years old
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline to primary endpoint (1 month post psilocybin session 2)
Awards & highlights
No Placebo-Only Group
Study Summary
This trial will test whether psilocybin can help treat PTSD in military veterans.
Eligible Conditions
- Post Traumatic Stress Disorder
- Trauma and Stressor Related Disorders
- Psychiatric Disorder
- Post-Traumatic Stress Disorder
- Traumatic Stress Disorders
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have only used hallucinogenic drugs a few times in your life.
Select...
You have a score of 35 or higher on a test that measures the severity of your symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to primary endpoint (1 month post psilocybin session 2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to primary endpoint (1 month post psilocybin session 2)
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 • NCT0206129344%
Headache
21%
Nausea
15%
Anxiety
8%
Suicidal Ideation
6%
Insomnia
6%
Depressed mood
4%
Abdominal pain upper
4%
Vomiting
4%
Corona virus infection
4%
Upper respiratory tract infection
4%
Viral upper resp. tract infection
4%
Alcohol poisoning
4%
Depression
4%
Pneumonia
2%
Illusion
2%
Urinary incontinence
2%
Biopsy cervix
2%
Palpitations
2%
Cataract
2%
Abdominal pain
2%
Toothache
2%
Pain
2%
Limb injury
2%
Muscle strain
2%
Blood pressure diastolic increased
2%
Blood pressure increased
2%
Back pain
2%
Musculoskeletal pain
2%
Myalgia
2%
Dizziness
2%
Psychomotor hyperactivity
2%
Alcohol withdrawal syndrome
2%
Dysphoria
2%
Testicular pain
2%
Hyperventilation
2%
Food poisoning
2%
Food allergy
2%
Dyspepsia
2%
Influenza
2%
Nasal congestion
2%
Skin cosmetic procedure
2%
Photopsia
2%
Diverticulitis
2%
Asthenia
2%
Fatigue
2%
Gingivitis
2%
Dyspnea
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Psilocybin
Diphenhydramine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~720
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
794 Previous Clinical Trials
459,690 Total Patients Enrolled
Alan K Davis, PhDPrincipal InvestigatorOhio State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with schizophrenia, bipolar I or II disorder or any other similar mental illness in the past or currently.You are between 21 and 64 years old.You have been diagnosed with Post-Traumatic Stress Disorder (PTSD) according to the DSM-5.You have a history of a suicide attempt that was serious and required medical attention.You have not used hallucinogenic drugs frequently in your lifetime.You have served in the US military.You have heart or blood vessel conditions.You have diabetes that requires insulin treatment.You are a former member of the US military.You are between 21 and 64 years of age.Your symptoms are very severe and you have a score of 35 or higher on a test that measures the severity of your condition.You have at least a high-school level of education or equivalent.You have been diagnosed with Post-Traumatic Stress Disorder (PTSD) according to a specific diagnostic manual called DSM-5.You must be in good overall health.You have a history of serious alcohol, tobacco or drug addiction within the past year.You have a mental health condition that makes it difficult to build a good relationship with your healthcare provider.You have heart or blood vessel problems.Your body weight is either significantly higher or lower than what is considered ideal.You have had a problem with drinking alcohol, smoking tobacco, or using drugs in the past year.You have a close family member (like a parent, sibling, or grandparent) who has schizophrenia, bipolar disorder, or other similar mental health conditions.You have a history of a serious suicide attempt.You have only used hallucinogenic drugs a few times in your life.You have a history of seizures caused by epilepsy.You are currently taking medication for mental health issues.You are significantly underweight or overweight (more than 25% outside the ideal range for your height).You are currently taking antidepressant medication.You have a score of 35 or higher on a test that measures the severity of your symptoms.You have diabetes that requires insulin for management.You are currently taking medication for mental health.Your close family member (parent, sibling, grandparent, aunt/uncle) has been diagnosed with schizophrenia, bipolar disorder type 1 or type 2, or any other psychotic disorder.You have a history of seizures due to epilepsy.You have been diagnosed with schizophrenia, other psychotic disorders, or bipolar disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin-assisted therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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. 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
I have watched YouTube channels where these former Military members who have seen combat like I have are reaching out and having success with these unconventional treatment methods and I felt exactly like these other Soldiers. I kept hearing positive results and I want to see if it cab work for me as well.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Average response time
- < 2 Days
Most responsive sites:
- Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center: < 48 hours
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