Low‑dose psilocybin plus mental imagery therapy for young people who self-harm

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Young people aged 16–25 who have recent self-harm and self-harm–related mental imagery will receive either a low (5 mg) dose of psilocybin or a placebo alongside a cognitive imagery rescripting intervention. The trial pairs drug dosing visits with guided imagery-based therapy sessions and uses safety monitoring including ECG and blood pressure checks. Participants will complete remote and in-person visits, app-based data collection, and follow-up assessments of self-harm imagery, urges, and behaviour. The design is an early-phase, controlled interventional protocol focused on feasibility, safety, and preliminary signals of clinical effect.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* At least 2 lifetime episodes of self-harm measured using the Self-Injurious Thoughts and Behaviours Interview (Nock et al., 2007) and at least 1 self-harm episode in the past month
* Self-harm-associated mental imagery in the past 6-weeks measured using the Self-harm Imagery Interview (Hales et al., 2011)
* Any gender
* Age: 16-25 years old
* Good command of the English language
* Mental capacity to provide written informed consent
* Participant is willing to engage in tasks showing images of self-harm
* Participant is 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 the dosing visit
* Comfortable using a computer and smartphone app for data collection, access to the internet from home and willing to have some of the study 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 their participation
* Have a medically significant condition which renders them unsuitable for the psychedelic component of the study (e.g., hypertension, diabetes, severe cardiovascular disease, hepatic or renal failure etc.)
* Previous psychedelic use
* Current or chronic history of kidney or liver disease
* Have previously experienced a serious adverse response after psychedelic use
* Intoxication on any of the visits, as assessed by difficulty in walking, the slurring of speech, difficulty concentrating or drowsiness
* Clinically significant head injury (e.g., requiring medical or surgical intervention) that in the opinion of the investigators, contraindicates their participation
* Severe learning disability (including dyslexia/dyspraxia) that needs support to perform daily work/school tasks
* Unwillingness or inability to follow the procedures outlined in the protocol
* Are currently using a psychoactive medication
* History of psychosurgery
* In the opinion of the study team, they are unlikely to comply with the study protocol and lifestyle restrictions that it imposes
* Unstable physical illness
* Heavy smoker
* Those needing regular specified medication that might interact adversely with psilocybin e.g., selective serotonin reuptake inhibitor, 5HT1 agonists, mirtazapine, trazodone, analgesics that have serotonergic effects (tramadol), MAOI's, antipsychotics with significant 5-HT2A receptor antagonist actions (risperidone, olanzapine, and quetiapine)
* Those unwilling to allow their GP or involved mental health practitioners to be informed of their participation
* Women of childbearing age who are not using reliable contraceptive methods
* Women of childbearing age who are unable to comply with or produce a positive pregnancy urine test

Where it's running

• Imperial College London
  London, United Kingdom Recruiting

Study contacts

• Principal investigator: Martina Di Simplicio, Dr — Imperial College London
• Study coordinator: Joanna Vamvakopoulou
• Email: imagine@imperial.ac.uk
• Phone: +44 (0) 7942292199

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.