Clinical TrialTraumatic Brain Injury (TBI)PsilocybinPsilocybinRecruiting

Treatment of Persistent Post-concussive Symptoms With Psilocybin Assisted Therapy (PatACT)

This randomised, quadruple-blind, placebo-controlled trial (n=40) will evaluate the safety, feasibility, and efficacy of psilocybin-assisted therapy in adults aged 18–65 with persistent post-concussion symptoms (PPCS). Participants will receive either a high dose (25mg) or a low dose (1mg) of psilocybin and undergo 5–6 weekly sessions of BrainACT, an adapted form of Acceptance and Commitment Therapy (ACT) for individuals with acquired brain injury.

Target Enrollment
40 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

A randomised, double-blind, parallel-group trial comparing a single 25 mg oral dose of PEX010 psilocybin with a 1 mg low-dose active comparator in adults with persistent post-concussion symptoms; participants receive preparatory psychoeducation and 5–6 weekly ACT sessions after dosing.

Primary outcomes assess safety and feasibility; efficacy outcomes include change in RPQ at 1 week, 4 weeks, 3 months and 6 months, plus secondary measures of headache, dizziness, mood, anxiety, PTSD symptoms, cognitive flexibility, emotional regulation, and quality of life.

Study Protocol

Preparation

1 sessions

Dosing

1 sessions

Integration

6 sessions

Therapeutic Protocol

act

Study Arms & Interventions

High dose

experimental

Single oral 25 mg psilocybin (PEX010) administered 24 h prior to first ACT session.

Interventions

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

    PEX010; single dose administered 24 h prior to first ACT session.

Low dose

active comparator

Single oral 1 mg psilocybin (active control) administered 24 h prior to first ACT session.

Interventions

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

    PEX010 low-dose active control; single dose administered 24 h prior to first ACT session.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Individuals of all sexes, gender identities, and ethnicities
  • Ages 18 to 65 years at the time of screening
  • Diagnosis of concussion based on the 2024 ACRM criteria
  • Meet ICD-10 criteria for PPCS for at least 3-months to a maximum of 5 years
  • Have an overall RPQ score ≥ 13 with 3 or more symptoms scored ≥3
  • Limited lifetime use of serotonergic hallucinogens
  • Ability to read/write English

Exclusion Criteria

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • 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, 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 hypoglycemia
  • Epilepsy with a history of seizures
  • Current or recent (within 12 weeks) participation in a clinical trial
  • Cognitive impairment (SLUMS score <20)
  • Suffered a moderate/severe TBI at least once in lifetime
  • Any other circumstances that, in the opinion of the investigators, compromises participant safety
  • Not actively in litigation related to their mTBI or other injury

Study Details

Locations

University of Calgary — Calgary, Alberta, Canada

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