PsiloIMAGINE: A Psychedelic-augmented Mental... — Clinical Trial Details

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.

Participants

Ages

16 – 25

Sexes

Male & Female

BMI

Psychosis History

Excluded

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

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin 5mg

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators