Low‑dose psilocybin plus mental imagery therapy for young people who self-harm
Investigating the Effects of a Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm Behaviour: an Experimental Medicine Study
This project tests whether a single low dose of psilocybin combined with a mental imagery technique can reduce self-harm urges in 16–25-year-olds who have recent self-harm and self-harm imagery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 16 Years to 25 Years |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06798636 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are 16–25 years old, fluent in English, psychedelic‑naïve, with at least two lifetime self-harm episodes (including one in the past month) and recent self-harm imagery, who can give informed consent and attend in-person dosing visits in London while completing some remote visits and app-based tasks.
Not a fit: People with a current or past history of psychosis or mania, unstable medical conditions, recent recreational drug use, inability to complete imagery tasks or remote visits, or who cannot travel to the London dosing site are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the approach could reduce the frequency or intensity of self-harm urges and offer a shorter or alternative treatment option for young people who self-harm.
How similar studies have performed: Psychedelic-assisted therapy has shown promising results in conditions like depression, but combining low-dose psilocybin specifically with imagery rescripting for self-harm is a novel approach with little prior direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
London
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.