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Psychedelic Substance

Psilocybin for PTSD

Phase 2
Waitlist Available
Led By Gosia Phillips, MD
Research Sponsored by Halucenex Life Sciences Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have treatment-resistant PTSD symptoms, defined as a CAPS score of ≥50 (signifying moderate to severe symptoms) following at least 3 months of prior SSRI or serotonin-norepinephrine reuptake inhibitor (SNRI) treatment in addition to at least 4 months of psychotherapy (adapted from Mithoefer et al, 2011).
Subjects must have treatment-resistant PTSD symptoms, defined as a CAPS score of ≥30 (signifying moderate to severe symptoms) following at least 3 months of prior SSRI or serotonin-norepinephrine reuptake inhibitor (SNRI) treatment in addition to at least 4 months of psychotherapy (adapted from Mithoefer et al, 2011).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 month follow up
Awards & highlights

Study Summary

This trial is investigating whether psilocybin, a psychedelic drug, can help people with PTSD who haven't responded to other treatments.

Who is the study for?
This trial is for adults aged 18-70 with treatment-resistant PTSD, having moderate to severe symptoms despite at least 3 months of SSRI or SNRI treatment and 4 months of psychotherapy. Participants must understand English. Excluded are those with certain psychiatric disorders, uncontrolled medical conditions, recent substance abuse, high caffeine intake, or who are pregnant without using contraception.Check my eligibility
What is being tested?
The study tests the effects of psilocybin on individuals with PTSD that hasn't improved after standard treatments. It aims to see if psilocybin can alleviate PTSD symptoms when traditional medications like paroxetine and sertraline have failed.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects from similar studies may include temporary anxiety or panic reactions during dosing sessions, changes in blood pressure and heart rate, nausea, headache and potential psychological distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Subjects must have treatment-resistant PTSD symptoms, defined as a CAPS score of ≥50 (signifying moderate to severe symptoms) following at least 3 months of prior SSRI or SNRI treatment in addition to at least 4 months of psychotherapy.
Select...
You have been receiving treatment for PTSD with medications called SSRIs or SNRIs, as well as therapy, for at least 3 months. However, your symptoms have not improved and you still have moderate to severe symptoms, as determined by a score of 30 or higher on a test called CAPS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PTSD symptom severity as measured by the Clinician-Administered PTSD Scale (CAPS-5)
PTSD symptom severity as measured by the Posttraumatic Checklist for the DSM-5 (PCL-5)
Primary efficacy of psilocybin using the 11-Dimension Altered States of Consciousness (11D-ASC) will assess
+3 more
Secondary outcome measures
Anxiety as measured by the Beck Anxiety Inventory (BAI).
Anxiety as measured by the State Trait Anxiety Inventory - Trait Version (STAI-T).
Body Mass Index (BMI)
+4 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
44%
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%
Urinary incontinence
2%
Illusion
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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Psilocybin treatment for treatment-resistant PTSDExperimental Treatment1 Intervention
Experimental Treatment: Experimental: Psilocybin 10mg (low dose) on Day 7 25mg (high dose) on Day 14 10mg dose (optional top-up low dose) at Month 7 Treatment Description: Drug: Psilocybin drug product suspension Psilocybin is manufactured as a bulk API powder. The psilocybin drug product suspension is prepared by a compounding pharmacist at the clinic site. The psilocybin drug product suspension will be mixed in a glass with water to produce the psilocybin solution for oral consumption. Subjects will be instructed to orally consume the study medication in the glass in its entirety. Psilocybin will be administered in the following doses and at the following time points for this study: 1 mL of 10mg/mL (low dose) on Day 7 (10 mg) 2.5 mL of 10 mg/mL (high dose) on Day 14 (25 mg) [Optional dose] 1 mL of 10mg/mL (low dose) on Month 7/Day 210 (10 mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Everest Clinical ResearchUNKNOWN
1 Previous Clinical Trials
275 Total Patients Enrolled
Halucenex Life Sciences Inc.Lead Sponsor
KGK Science Inc.Industry Sponsor
78 Previous Clinical Trials
6,126 Total Patients Enrolled

Media Library

Psilocybin (Psychedelic Substance) Clinical Trial Eligibility Overview. Trial Name: NCT05243329 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Psilocybin treatment for treatment-resistant PTSD
Post-Traumatic Stress Disorder Clinical Trial 2023: Psilocybin Highlights & Side Effects. Trial Name: NCT05243329 — Phase 2
Psilocybin (Psychedelic Substance) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05243329 — Phase 2

Frequently Asked Questions

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

Is this clinical research offering participation to individuals aged 25 and over?

"The lower limit of eligibility is 18, while the upper cap for admission has been set at 70."

Answered by AI

Am I qualified to partake in this research endeavor?

"The prerequisites for enrolment in this research include moral injury and an age between 18-70. This experimental trial is limited to a maximum of 20 participants."

Answered by AI

Is the administration of Psilocybin free from major hazards?

"Considering that we are in the second phase of this research, there is some evidence to suggest Psilocybin's safety; as such, it receives a score of 2."

Answered by AI

Are there still opportunities to take part in this experiment?

"The clinicaltrials.gov website confirms that this trial is no longer enrolling patients, having been initially posted on October 3rd 2022 and last updated the same day. Despite not being able to participate in this particular research project, there are a plethora of other studies actively recruiting participants resulting in 1237 options currently available."

Answered by AI

Who else is applying?

What state do they live in?
Washington
California
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
Halucenex Life Sciences Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Halucenex Life Sciences Inc.: < 24 hours
Average response time
  • < 2 Days
~8 spots leftby Mar 2025