💬In plain words
What the trial is, and whether it could suit you
Approximately 20% of young people experience self-harm behaviour in their lives. Self-harm can occur across different mental health disorders, and lead to negative outcomes and risk of suicide. Current treatments are long, costly and do not suit all young people, making it essential to research alternative treatments. Therapy combined with psychedelic drugs has recently been shown to be helpful in a variety of mental health disorders, including depression. This research project will explore the mechanisms by which combining a low dose of psychedelic psilocybin with a cognitive technique may target self-harm behaviour in young people (aged 16-25).
Previous research has shown that mental images of self-harm are common among individuals who self-harm and can increase the urge to self-harm. Imagery Re-Scripting (ImRS) is a cognitive technique that guides an individual to replace mental imag
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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