Phase 2 Eating Disorders Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 25 years old at the time of screening
• You have been diagnosed with any type of Anorexia Nervosa according to standard medical guidelines (DSM-5)
• You are currently experiencing symptoms of Anorexia Nervosa
• You are comfortable reading and writing in English
• You are able to understand and agree to participate in the study
• You do not expect any changes to your medications or any surgical procedures during the trial
• You are able to attend all required in-person and remote study visits and take part in all data collection
• You can identify one or two family members or close friends who are willing to join the study with you and attend some therapy sessions
• You agree to use a reliable form of contraception for two weeks before starting and one month after finishing the study
• You agree to avoid non-prescription medications, nutritional supplements, and herbal supplements for one week before each treatment session, unless approved by the research team (common exceptions like paracetamol, anti-inflammatories, and standard vitamins may be allowed)
• You agree to drink roughly the same amount of caffeinated drinks as you normally would on the mornings of treatment sessions, or agree to avoid them if you do not normally drink them

Who may not be able to join:

• You are currently pregnant, become pregnant during the study, or are breastfeeding
• You have a personal history of bipolar disorder or a psychotic disorder
• Your Body Mass Index (BMI) is below 12 at the time of screening
• You have unstable blood pressure, heart rate, or body temperature
• Your blood test results show abnormal levels of certain substances related to kidney, liver, or mineral function (confirm with trial site)
• You have abnormal results on a heart tracing test (ECG/electrocardiogram)
• You have been hospitalised or in a residential care programme for more than 2 of the past 4 weeks before screening
• You are unwilling to avoid alcohol, CBD, THC, marijuana, and recreational drugs for 48 hours before and after each treatment session, or to avoid nicotine for 10 hours before and after each treatment session
• You test positive for certain substances (including amphetamines, cocaine, cannabis, MDMA, opioids, or benzodiazepines) on the morning of a treatment session
• You have a history of heart or cardiovascular disease
• You have an uncontrolled hormonal or glandular condition, such as diabetes or a thyroid condition
• You have a significant uncontrolled digestive illness (as judged by the study doctor)
• You have a significant uncontrolled neurological condition, such as uncontrolled seizures (as judged by the study doctor)
• You are currently taking medications that are not allowed in the study and are unable or unwilling to stop taking them safely
• You have a fear of needles
• You are currently enrolled in another clinical trial
• You are allergic or intolerant to any ingredient in the study drug
• You have had a severe reaction to psychedelic substances in the past (as judged by the study doctors)
• You are considered at high risk of self-harm or suicide
• You have a mental health condition that would prevent you from engaging with the treatment team
• You are unwilling or unable to follow the treatment plan, including drinking sports drinks on treatment days
• Any study doctor feels it would be unsafe for you to participate, for any reason

Important: Always verify eligibility with the trial site directly before applying.