Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder

NCT05562973 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: IRB00288303
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and potential efficacy of psilocybin-assisted psychotherapy to reduce post-traumatic stress disorder (PTSD) severity in a sample of individuals with PTSD.

Conditions

Post-Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (4)

• Mean Peak Post-Administration Blood Pressure

  Blood pressure will be monitored at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration. Mean peak blood pressure across the 3 psilocybin sessions will be used as the outcome measure.

  Approximately 1.5 - 2 months

• Mean Peak Post-Administration Heart Rate

  Heart rate will be monitored at 30, 60, 90, 120, 180, 240, 300, and 360 minutes after capsule administration. The mean peak heart rate across the 3 psilocybin sessions will be used as the outcome measure.

  Approximately 1.5 - 2 months

• Mean Pre-Administration Suicide Ideation Scores (Columbia Suicide Severity Rating Scale - Severity Factor)

  The Columbia Suicide Severity Rating Scale will be used to assess baseline severity of suicide ideation. Scores on the Severity subscale range from 1 - 5, where 1= "wish to be dead"; 2 = "nonspecific active suicidal thoughts"; 3 = "suicidal thoughts with methods"; 4 = "suicidal intent"; and 5 = "suicidal intent with plan". The mean of the Severity subscale scores from the 3 preparation visits will be used as the outcome measure.

  Approximately 3 weeks

• Mean Change in Suicide Ideation Scores (Columbia Suicide Severity Rating Scale - Severity Factor)

  The Columbia Suicide Severity Rating Scale will be used to assess post-administration severity of suicide ideation. Scores on the Severity subscale range from 1 - 5, where 1= "wish to be dead"; 2 = "nonspecific active suicidal thoughts"; 3 = "suicidal thoughts with methods"; 4 = "suicidal intent"; and 5 = "suicidal intent with plan". The mean change in Severity subscale scores between the preparation visits and the integration visits will be used as the outcome measure.

  Approximately 3 weeks pre-administration; approximately 1.5 - 2 months post-administration

Secondary Outcomes (2)

• Mean Change in Clinician-Administered PTSD Scale for DSM-5 scores

  Approximately 3 weeks pre-administration; approximately 1.5 - 2 months post-administration

• Mean Change in PTSD Checklist Scores

  Approximately 3 weeks pre-administration; approximately 1.5 - 2 months post-administration

Study Arms (5)

Dose Sequence 1 (15, 20, 25)

EXPERIMENTAL

Psilocybin dose sequence Session 1: 15 mg Session 2: 20 mg Session 3: 25 mg

Drug: Psilocybin

Dose Sequence 2 (20, 25, 30)

EXPERIMENTAL

Psilocybin dose sequence Session 1: 20 mg Session 2: 25 mg Session 3: 30 mg

Drug: Psilocybin

Dose Sequence 3 (25, 30, 35)

EXPERIMENTAL

Psilocybin dose sequence Session 1: 25 mg Session 2: 30 mg Session 3: 35 mg

Drug: Psilocybin

Dose Sequence 4 (30, 35, 40)

EXPERIMENTAL

Psilocybin dose sequence Session 1: 30 mg Session 2: 35 mg Session 3: 40 mg

Drug: Psilocybin

Dose Sequence 5 (35, 40, 45)

EXPERIMENTAL

Psilocybin dose sequence Session 1: 35 mg Session 2: 40 mg Session 3: 45 mg

Drug: Psilocybin

Interventions

Psilocybin DRUG

Participants will receive three psilocybin sessions, at least two weeks apart.

Dose Sequence 1 (15, 20, 25); Dose Sequence 2 (20, 25, 30); Dose Sequence 3 (25, 30, 35); Dose Sequence 4 (30, 35, 40); Dose Sequence 5 (35, 40, 45)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Have given written informed consent
• Read, write, and speak English
• At Screening, meet Diagnostic and Statistical Manual-5th edition (DSM-5) criteria for current PTSD with a symptom duration of 6 months or longer according to the Clinician-Administered PTSD Scale for DSM-5
• Able to complete the study measures
• Previously sought treatment for PTSD (e.g., prolonged exposure therapy, cognitive processing therapy, sertraline, paroxetine)
• Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests (Complete Blood Count, Comprehensive Metabolic Panel, urine beta-human chorionic gonadotropin, urine toxicology screen).
• Current physical dependence (as evidenced by self-reported withdrawal symptoms) on a drug other than caffeine or nicotine
• Seizure disorder
• Receiving current treatment for PTSD
• Cardiovascular conditions: angina, a clinically significant ECG abnormality (e.g. atrial fibrillation or corrected QT interval \>450msec), transient ischemic attack (TIA) in the last 6 months, stroke, or uncontrolled hypertension with resting blood pressure systolic \>150 or diastolic \>95.
• Recent (\<1year) intracranial or subarachnoid hemorrhage, ischemic stroke, TIA
• Pulmonary disease: chronic obstructive pulmonary disease, active asthma (inhaler use in last 6 months)
• Diabetes mellitus treated with insulin or oral hypoglycemic agents
• Current suicidal ideation or suicidality
• Current engagement in evidence-based PTSD therapy/treatment (prior to psilocybin session)

Sponsors & Collaborators

• Johns Hopkins University: lead

Related Publications (1)

• Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.

  PMID: 27909165 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Matthew W Johnson, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 3, 2022
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share