Clinical TrialPTSDPsilocybinUnknown status

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

The present study aims to investigate the effect of psilocybin on treatment-resistant PTSD

Target Enrollment
20 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This single-group, Phase II study will evaluate oral psilocybin (10 mg and 25 mg; optional 10 mg booster at month 7) in 20 adults with treatment-resistant PTSD to assess safety, tolerability and preliminary clinical effect.

Psilocybin is administered as an aqueous suspension prepared on-site and taken orally. Outcomes include CAPS scores, safety measures, and feasibility for further controlled trials.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

Oral psilocybin suspension: 10 mg (Day 7) and 25 mg (Day 14); optional 10 mg booster at Month 7 (Day 210).

Interventions

  • Psilocybin10 - 25 mg
    via Oral• two sessions• 3 doses total

    10 mg on Day 7; 25 mg on Day 14; optional 10 mg at Month 7 (Day 210).

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 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.
  • 1. Subjects must be ≥18 and ≤70 years of age.
  • 2. Subjects must meet the Diagnostic & Statistical Manual of Mental Disorders - Version V (DSM-V) criteria for TR-PTSD.
  • 3. 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 SNRI treatment in addition to at least 4 months of psychotherapy (adapted from Mithoefer et al, 2011).
  • 4. Subjects must be able to communicate in English.

Exclusion Criteria

  • Exclusion Criteria:
  • Subjects meeting any of the following criteria will not be eligible for participation in the study:
  • 1. 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).
  • 2. Uncontrolled hypertension or BP ≥140/90 mmHg over 2 days, with at least 4 BP assessments completed.
  • 3. 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.
  • 4. 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.).
  • 5. 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.
  • 6. Blood draw or needle phobia.
  • 7. Suicidal attempt or active ideation deemed to present risk of suicide as judged by study clinical staff in past 30 days.
  • 8. BMI <14 or >42 or the Qualified investigator deems the patient sufficiently healthy to participate.
  • 9. 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.
  • 10. Any uncontrolled eating disorder (e.g., purging or anorexia or worsening of directionally undesirable weight change of 5 kg in past 30 days).
  • 11. Subjects with a diagnosis of DSM-5 personality disorder which has a major impact on the subject's current psychiatric status
  • 12. Use of any investigational drug, hallucinogen, or ketamine/esketamine within the past 30 days, or plan to use during the study.

Study Details

  • Status
    Unknown status
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2022-02-18
    End: 2022-10-18
  • Compound
    Psilocybin
  • Topic
    PTSD

Locations

Halucenex Life Sciences Inc. — Windsor, Nova Scotia, Canada

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