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

Launched by IMPERIAL COLLEGE LONDON · Jan 22, 2025

Keywords

ClinConnect Summary

The PsiloIMAGINE clinical trial is studying a new approach to help young people aged 16 to 25 who struggle with self-harm. The researchers want to see if combining a low dose of a psychedelic substance called psilocybin with a specific therapy technique called Imagery Re-Scripting (ImRS) can reduce harmful thoughts and urges related to self-harm. ImRS helps individuals replace negative mental images with more positive ones, but some people find it hard to face their difficult emotions during this process. The hope is that psilocybin can make facing these emotions easier, allowing participants to create healthier mental images and coping strategies.

To participate in this trial, individuals must have experienced self-harm at least twice in their lifetime, with at least one incident occurring in the past month. They should also have been dealing with self-harm-related thoughts in the last six weeks. Participants will need to be comfortable discussing their mental health and using technology for the study. Importantly, they should not have any severe mental health issues, a history of certain medical conditions, or previous use of psychedelics. This trial is still in the planning stages and is not yet recruiting participants, but it aims to pave the way for future treatments for self-harm in young people.

Gender

ALL

Eligibility 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