About the PsiloGambling study
PsiloGambling is a clinical research study examining what happens in the brain and body when people with gambling disorder receive psilocybin in a carefully controlled research setting. Psilocybin is a psychedelic substance and the main active ingredient in “magic mushrooms”. In the UK, it is a Schedule 1 controlled drug and cannot currently be prescribed outside an approved research study.
The study is being conducted by the Centre for Psychedelic Research at 51³Ô¹ÏÍø, together with the National Institute for Health and Care Research. 51³Ô¹ÏÍø is the study sponsor. The research has received a favourable opinion from a Research Ethics Committee and will be conducted according to Good Clinical Practice.
Researchers will use functional magnetic resonance imaging (fMRI), electroencephalography (EEG), questionnaires, interviews, computer-based tasks and biological measurements to explore whether psilocybin changes brain activity and processes associated with reward, cognitive function, behaviour and gambling. The study will include up to 35 participants.
This is a research study, not a treatment programme. Some people may experience an improvement in their gambling-related symptoms, but this cannot be promised. The main purpose is to improve scientific understanding and help inform future research into psychedelic therapy and addiction.
Who may be able to take part?
The study is looking for people who:
- Are aged 18 or over.
- Have a diagnosis of moderate to severe gambling disorder according to DSM-5 criteria.
- Are seeking or receiving treatment through the National Gambling Clinic.
- Can read, understand and provide information in English.
- Are able and willing to attend the study visits and complete the required assessments.
A telephone or video pre-screening appointment, followed by an in-person medical screening, will determine whether it is safe and appropriate for someone to participate. Some medical or mental health conditions, medications and patterns of alcohol or other drug use may mean that a person cannot take part. Participants should continue taking their usual medication unless advised otherwise by their prescriber or GP.
What does taking part involve?
Participation lasts approximately four and a half months and includes an initial pre-screening appointment and eight study visits. Most visits take place at the 51³Ô¹ÏÍø Clinical Research Facility at Hammersmith Hospital and the nearby Perceptive Imaging Centre in West London.
Before receiving psilocybin, participants complete medical and psychological assessments and meet the two trained study guides who will support them throughout the study. Preparatory visits include questionnaires, interviews, computer-based tasks, brain scans and biological measures. Screening also includes a physical examination, blood and urine tests, an ECG and pregnancy testing where applicable.
On the dosing day, participants receive one dose of psilocybin in capsule form. The visit lasts approximately eight to nine hours. Participants are supported throughout by two study guides, with a study doctor nearby. The room is arranged to provide a calm environment, and participants are offered an eye mask and music. EEG and other physiological measurements are taken during the session. The effects of psilocybin usually begin within about 45 minutes and can last for five to six hours.
Before leaving, each participant is assessed by a study doctor. Participants must not drive for the rest of the day or operate machinery for 24 hours. They should normally leave with a trusted friend or relative, or travel home by taxi with someone available to meet them.
Follow-up visits take place the following day, after one week, after approximately one month and at three months. These include supported integration sessions, which provide an opportunity to discuss and reflect on the psilocybin experience. Participants also complete further brain scans, questionnaires, interviews, computer tasks and physical measurements.
Across the study, participants are expected to complete four MRI scans and four EEG recordings. Blood and stool samples are also collected to investigate biological and gut-microbiome changes. Participants may optionally choose to wear an Oura fitness-tracking ring to record measures such as sleep, temperature and heart rate. Choosing not to take part in this optional element will not affect participation or payment.
What are the possible risks?
Psilocybin can affect perception, emotions, thinking and a person’s sense of time. Experiences vary considerably. Possible short-term effects include nausea, anxiety, headache, dizziness, changes in blood pressure or heart rate, visual effects and difficult or frightening thoughts. Rarely, people may experience longer-lasting visual changes or a worsening of their mental health.
The study includes preparation, continuous support during dosing, medical supervision and follow-up integration sessions to reduce and manage these risks. Emergency medication and hospital facilities are available if clinically necessary.
Some questionnaires, interviews and gambling-related images or videos may bring up difficult emotions or cravings. Participants are encouraged to tell the team if they feel distressed and may take breaks or access additional support. MRI scanning can feel noisy or confined, although participants can communicate with the research team and stop a scan at any time. EEG is non-invasive and has no known significant risks.
Choice, privacy and support
Taking part is entirely voluntary. A decision not to participate will not affect a person’s current or future care. Participants may leave the study at any time without giving a reason, although information and samples already collected may need to be retained for the integrity of the research.
51³Ô¹ÏÍø will securely manage participants’ personal information. Research data will normally be coded so that people who do not need to know a participant’s identity cannot see their name or contact details. Reports and publications will not identify individual participants. Some coded information or samples may be shared with approved research partners in the UK or internationally under appropriate data-protection arrangements.
Study-related travel expenses will be reimbursed. Participants who complete all visits and MRI and EEG assessments may receive vouchers worth up to £612.50, with payment adjusted according to the visits completed if someone leaves the study early.
Interested in finding out more?
To ask a question or express an interest in the study, please contact: imperial.psilogambling@nhs.net
