Clinical TrialPTSDPsilocybinPsilocybinNot yet recruiting

Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence (PsiPTSD)

This quadruple-blind, randomised controlled trial (n=76) will study the effects of psilocybin (25mg or 1mg) combined with Acceptance and Commitment Therapy (ACT) in adult survivors of intimate partner violence (IPV) with post-traumatic stress disorder (PTSD).

Target Enrollment
76 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, quadruple-blind, parallel-group Phase II trial comparing a single therapeutic psilocybin dose (25 mg) versus a low-dose active comparator (1 mg), each given 24 hours before the first ACT session, in IPV survivors with chronic PTSD (n=76).

All participants receive 5–6 weekly ACT sessions after dosing; outcomes include PCL-5 and CAPS-5 as primary efficacy measures, with secondary assessment of mood, anxiety, cognitive function, motor ability, quality of life and exploratory blood biomarkers.

Assessments occur at baseline, 1 week, 4 weeks, 3 months (PCL-5 only online) and 6 months post-dosing; allocation is 1:1 with blocked randomisation and central pharmacy blinding procedures.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

6 sessions

Therapeutic Protocol

act

Study Arms & Interventions

High Dose

experimental

High dose (25 mg) PEX010 psilocybin, single oral administration given 24 hours prior to first ACT session; planned 38 participants.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    PEX010 single therapeutic dose (25 mg).

Low Dose

active comparator

Low dose (1 mg) PEX010 psilocybin, single oral administration given 24 hours prior to first ACT session; planned 38 participants (active control).

Interventions

  • Psilocybin1 mg
    via Oral• single dose• 1 doses total

    PEX010 low-dose active control (1 mg).

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Individuals of all sexes, gender identities, and ethnicities
  • Ages 18 to 65 years at the time of screening
  • At least 6 months since last IPV incident
  • A score of 1 on the Composite Abuse Scale with repetition of abusive events
  • Minimum PCL-5 score of ≥ 33
  • Limited lifetime use of serotonergic hallucinogens
  • Ability to read/write English

Exclusion Criteria

  • Exclusion Criteria:
  • Severe or moderate substance use disorder other than nicotine in past 6 months
  • Lifetime diagnosis of schizophrenia or bipolar disorders (or first- or second-degree relative)
  • Active suicidal ideation or serious attempt within the past 1 year
  • Current pregnancy or nursing, or trying to become pregnant
  • Any notable abnormality on ECG or routine medical blood laboratory test
  • Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycaemia
  • Epilepsy with a history of seizures
  • Current or recent (within 12 weeks) participation in a clinical trial
  • Cognitive impairment (SLUMS score <20)
  • Moderate/severe TBI at any time in lifetime or mild TBI within last 6 months
  • Any other circumstances that, in the opinion of the investigators, compromise participant safety
  • Not compelled to enter treatment to avoid legal consequences

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment76 participants
  • Timeline
    Start: 2025-08-01
    End: 2029-08-01
  • Compounds
    PsilocybinPsilocybin
  • Topic
    PTSD

Locations

University of Calgary — Calgary, Alberta, Canada
The University of British Columbia - Okanagan Campus — Kelowna, British Columbia, Canada
Vancouver Island University — Nanaimo, British Columbia, Canada

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