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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 month follow up
Awards & highlights

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.

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
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Oropharyngeal pain
4%
Suicidal Ideation
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Rhinorrhea
2%
Musculoskeletal pain
2%
Oedema
2%
Pyrexia
2%
Peripheral swelling
2%
Restlessness
2%
Vomiting
2%
Fungal infection
2%
Hypoesthesia
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
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 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for PTSD, such as SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors), work by increasing the levels of serotonin and norepinephrine in the brain, which helps to regulate mood and anxiety. Psilocybin, a psychedelic compound, is being studied for its potential to treat PTSD by affecting neurobiological pathways, including serotonin receptors, which may help in reducing symptoms like anxiety, depression, and re-experiencing traumatic events. These mechanisms are crucial for PTSD patients as they target the underlying neurobiological disruptions that contribute to the disorder, potentially offering faster and more effective symptom relief compared to traditional treatments.
PTSD: from neurobiology to pharmacological treatments.

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
6,140 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
~7 spots leftby Jul 2025