BridgeMD
New treatment option for Self Harm
Official title PsiloIMAGINE: A Psychedelic-augmented Mental Imagery-based Intervention for Young People With Self-harm
ClinicalTrials.gov ID: NCT06798636
What this study is testing
What is Psilocybin 5 mg with cognitive behavioural therapy intervention?
Psilocybin 5 mg with cognitive behavioural therapy intervention is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for self harm.
Also referred to as Psilocybin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 25
You may be able to join if
- 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-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
You likely can't join if
- 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...
- Previous psychedelic use
- Current or chronic history of kidney or liver disease
- Have previously experienced a serious adverse response after psychedelic use
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.