Your session is about to expire
← Back to Search
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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to primary endpoint (1 month post psilocybin session 2)
Awards & highlights
Summary
This trial aims to test if using psilocybin along with therapy can safely and effectively treat PTSD in U.S. Military Veterans. Psilocybin helps change brain activity, making it easier for veterans to process their trauma during therapy.
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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Columbia Suicide Severity Rating Scale (C-SSRS)
Therapy, Computer-Assisted
Secondary study objectives
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 • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
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%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
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
~750
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
859 Previous Clinical Trials
642,750 Total Patients Enrolled
Alan K Davis, PhDPrincipal InvestigatorOhio State University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 21 and 64 years old.I use insulin to manage my diabetes.I have been diagnosed with PTSD.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 not used hallucinogenic drugs frequently in your lifetime.I am between 21 and 64 years old.I am currently pregnant.You have a history of a suicide attempt that was serious and required medical attention.I am currently taking medication that affects serotonin in my brain.I am currently taking medication that affects my brain's serotonin levels daily.My weight is more than 25% over or under the ideal range.You are a former member of the US military.I have not taken antidepressants before joining this study.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.I am currently taking antidepressants.I have epilepsy with a history of seizures.You have been diagnosed with schizophrenia, bipolar I or II disorder or any other similar mental illness in the past or currently.I have a heart condition.I am currently on medication for my mental health.A close family member has schizophrenia, bipolar disorder, or a similar condition.
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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger