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

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