Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder

NCT05243329 | Unknown Phase 2

• 1 other identifier: 22HLCPP01/HCX-2020-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Post-traumatic stress disorder (PTSD) is a complex disorder expressed as a variety of neurobiological symptoms, including anxiety, re-experiencing, hyperarousal, and avoidance symptoms, along with comorbidities such as anxiety, depression, and increased risk for self-medicating substance abuse. Currently, there are only two approved medications in the United States (US) for PTSD, paroxetine and sertraline. Psychedelic medications, including psilocybin, have recently received breakthrough designation by the US Food and Drug Administration (FDA) for other psychiatric indications. Although no formal clinical trials have yet investigated psychedelic substances for the treatment of PTSD, the available evidence warrants such an investigation. The present study aims to investigate the effect of psilocybin on treatment-resistant PTSD.

Conditions

Treatment Resistant Disorders; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (6)

• Primary efficacy of psilocybin using the 11-Dimension Altered States of Consciousness (11D-ASC) will assess

  This is a 42 item questionnaire assessing patient-rated subjective intensity of psilocybin's effects

  Day 14

• PTSD symptom severity as measured by the Clinician-Administered PTSD Scale (CAPS-5)

  Total CAPS-5 Scores range from 0-80. Higher scores indicate greater symptom severity.

  Screening to 12 months follow up

• PTSD symptom severity as measured by the Posttraumatic Checklist for the DSM-5 (PCL-5)

  Total PCL-5 Scores range from 0-80. Higher scores indicate greater symptom severity.

  Screening to 12 months follow up

• Subjective distress caused by traumatic events as measured by the Impact of Events Scale Revised (IES-R).

  The IES-R is a 22-item self-report measure where respondents are asked to identify a specific stressful life event and then indicate how much they were distressed or bothered during the past seven days by each "difficulty" listed. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88).

  Screening to 12 months follow up

• Symptoms of Psychopathology as measured by the Symptom Checklist 90-R (SC90-R).

  The 90 items in the SC90-R are assessed by the subject using a 5-point rating scale.

  Screening to 12 months follow up

• Symptom severity, treatment response, and the efficacy of treatment studies of patients with mental disorders as measured by the Clinical Global Impression - Improvement (CGI-I)/ Clinical Global Impression - Severity (CGI-S).

  The CGI-S scale is a 7-point, clinician-rated scale (ranging from 1 to 7, with 1 indicating a "normal state" and 7 indicating "among the most extremely ill patients").

  Day 22

Secondary Outcomes (7)

• Anxiety as measured by the Beck Anxiety Inventory (BAI).

  Up to 12 month follow up

• Anxiety as measured by the State Trait Anxiety Inventory - Trait Version (STAI-T).

  Up to 6 month follow up

• Depression as measured by the Beck Depression Inventory (BDI).

  Up to 12 month follow up

• Depression as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).

  Up to 12 month follow up

• Impairments in daily living as measured by the Sheehan Disability Scale (SDS).

  Up to 12 month follow up

Study Arms (1)

Psilocybin treatment for treatment-resistant PTSD

EXPERIMENTAL

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)

Drug: Psilocybin

Interventions

Psilocybin DRUG

10 mg or 25 mg oral aqueous psilocybin solution

Psilocybin treatment for treatment-resistant PTSD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- After signing and dating the informed consent documents, subject eligibility will be assessed. Subjects must meet the following criteria to be eligible for enrollment into the study.
• Subjects must be ≥18 and ≤70 years of age.
• Subjects must meet the Diagnostic \& Statistical Manual of Mental Disorders - Version V (DSM-V) criteria for TR-PTSD.
• 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).
• Subjects must be able to communicate in English.

You may not qualify if:

• Subjects meeting any of the following criteria will not be eligible for participation in the study:
• Pregnant individuals and those of childbearing age not using effective contraception (e.g., oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine coil, intrauterine device, tubal ligation, or barrier method).
• Uncontrolled hypertension or BP ≥140/90 mmHg over 2 days, with at least 4 BP assessments completed.
• In the clinical judgement of the investigator, any hazard-posing medical, emotional, or significant character disorder or condition rendering unsuitability for the study. For example, poorly controlled diabetes, severe cardiovascular disease, seizure disorders, sleep apnea disorders (suspected or ineffectively treated), untrustworthiness, suicidality, etc.
• Any use of methamphetamines or any injection drug abuse in the past 30 days and/or a positive test for drugs of abuse (e.g., cocaine, amphetamines, opiates, benzodiazepines, etc.).
• Any other significant substance use disorder that may interfere with study objectives including consuming \>5 cups of caffeinated coffee a day or inability, without discomfort, to refrain from smoking cigarettes or cannabis, or consuming alcohol for 7 hours.
• Blood draw or needle phobia.
• Suicidal attempt or active ideation deemed to present risk of suicide as judged by study clinical staff in past 30 days..
• BMI \<14 or \>42 or the Qualified investigator deems the patient sufficiently healthy to participate.
• Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder or brief psychotic disorder; current or previous history of bipolar disorder, or obsessive-compulsive disorder.
• Any uncontrolled eating disorder (e.g., purging or anorexia or worsening of directionally undesirable weight change of 5 kg in past 30 days).
• Subjects with a diagnosis of DSM-5 personality disorder which has a major impact on the subject's current psychiatric status
• Use of any investigational drug, hallucinogen, or ketamine/esketamine within the past 30 days, or plan to use during the study.

Sponsors & Collaborators

• Halucenex Life Sciences Inc.: lead
• KGK Science Inc.: collaborator

Study Sites (1)

Halucenex Life Sciences Inc.

Windsor, Nova Scotia, B0N2T0, Canada

Location

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

• Lisa Batten, PhD

  Halucenex Life Sciences

  STUDY DIRECTOR

• Paige Stevens, MD

  Contracted

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: February 17, 2022
• Study Start: October 3, 2022
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)