Clinical TrialSuicidalityPsilocybinPlaceboRecruiting

PsiloIMAGINE: A Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm

This triple-blind, placebo-controlled trial (n=30) will investigate the effects of a sub-hallucinogenic dose of psilocybin (5 mg) combined with Imagery Re-Scripting (ImRS) on cognitive processes and self-harm behaviour in young people aged 16–25.

Target Enrollment
30 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

A randomised, triple-blind, parallel-group early-phase study (n=30) will compare a single 5 mg oral dose of psilocybin plus Imagery Re-Scripting (ImRS) versus an inert placebo capsule plus ImRS in young people with recent self-harm.

The study tests whether a low, sub-hallucinogenic psilocybin dose enhances toleration of difficult emotions and cognitive flexibility during ImRS, reducing vivid self-harm imagery and associated negative affect compared with ImRS alone.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

cbt

Study Arms & Interventions

Psilocybin 5mg

experimental

Oral 5 mg psilocybin administered prior to Imagery Re-Scripting (ImRS).

Interventions

  • Psilocybin5 mg
    via Oral• single dose• 1 doses total

    Paired with Imagery Re-Scripting (ImRS) sessions.

Placebo

inactive

Oral 25 mg MCC inert placebo capsule preceding ImRS.

Interventions

  • Placebo25 mg
    via Oral• single dose• 1 doses total

    25 mg microcrystalline cellulose inert capsule.

Participants

Ages
16 – 25
Sexes
Male & Female

Inclusion Criteria

  • At least 2 lifetime episodes of self-harm (Self-Injurious Thoughts and Behaviours Interview) and at least 1 self-harm episode in the past month
  • Self-harm-associated mental imagery in the past 6 weeks (Self-harm Imagery Interview)
  • Any gender
  • Age 16-25 years
  • Good command of English
  • Mental capacity to provide written informed consent
  • Willing to engage in tasks showing images of self-harm
  • Willing to talk about mental health and self-harm behaviour
  • Normal ECG and blood pressure (determined by study medic)
  • Psychedelic naïve
  • No recreational drug use 7 days prior to dosing visit
  • Comfortable using computer and smartphone app for data collection and able to access internet; willing to have some visits via video-link

Exclusion Criteria

  • Current or past history of psychosis or mania in themselves or a first-degree relative
  • Current severe suicidal ideation that constitutes a risk for participation
  • Medically significant condition rendering them unsuitable for psychedelic component (e.g., hypertension, diabetes, severe cardiovascular disease, hepatic or renal failure)
  • Previous psychedelic use
  • Current or chronic kidney or liver disease
  • Previous serious adverse response after psychedelic use
  • Intoxication on any visit (difficulty walking, slurred speech, difficulty concentrating, drowsiness)
  • Clinically significant head injury contraindicating participation
  • Severe learning disability requiring support for daily tasks
  • Unwillingness or inability to follow protocol procedures
  • Current use of psychoactive medication
  • History of psychosurgery
  • Unlikely to comply with protocol and lifestyle restrictions
  • Unstable physical illness
  • Heavy smoker
  • Regular specified medication that might interact adversely with psilocybin (e.g., SSRI, 5HT1 agonists, mirtazapine, trazodone, serotonergic analgesics, MAOIs, antipsychotics with significant 5-HT2A antagonist actions)
  • Unwillingness to allow GP or mental health practitioners to be informed of participation
  • Women of childbearing potential not using reliable contraception or unable to comply with pregnancy testing

Study Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment30 participants
  • Timeline
    Start: 2025-03-01
    End: 2026-10-31
  • Compounds
    PsilocybinPlacebo
  • Topic
    Suicidality

Locations

Imperial College London — London, United Kingdom

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