Healthy volunteers Other
Conditions
Interventions
This is a single-center interventional double-blind randomized placebo-controlled experimental medicine study.
To explore the cognitive effects of oral scopolamine, 60 healthy volunteers (aged 18–45)
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to give informed consent for participation in the study 2. Aged 18-45 years 3. Resident in the UK for the duration of the study 4. Good vision and hearing 5. Sufficiently fluent English to understand and complete the study 6. Body mass index (BMI) within the range of 18-35 kg/m2 7. Willing to avoid drinking alcohol for 24 hours before and on the day of the study visit 8. Willing and able to travel to the Warneford Hospital (Oxford) for a single research visit
Exclusion criteria
Exclusion criteria: 1. Currently receiving or seeking treatment for any mental health condition 2. Any past or current history of severe and/or serious psychiatric disorder, including but not limited to schizophrenia, psychosis, bipolar affective disorder, severe major depressive disorder, obsessive compulsive disorder (covered in SCID-5/MINI assessment in screening procedures) 3. ADHD requiring treatment with stimulant or other centrally-acting drugs 4. Regular alcohol consumption of more than 21 units per week 5. A head injury causing concussion or unconsciousness in the past 6 months 6. Pregnancy / intention to become pregnant during the study or breastfeeding 7. Any use of recreational drugs in the last three months 8. Participation in any other drug study in the last three months 9. Participation in any other study with the same tasks in the last year 10. Glaucoma 11. Current use of psychoactive medication that in the opinion of the Investigator may interfere with the study measures 12. History of, or current medical condition(s) which, in the opinion of the Investigator may interfere with the safety of the participant or the scientific integrity of the study, including epilepsy/seizures, brain injury, heart, metabolic, gastrointestinal, liver or kidney conditions, Central Nervous System (CNS) tumours, severe neurological problems (e.g. Parkinson’s disease; blackouts requiring hospitalisation; dementia) 13. Any physical (including visual and auditory), cognitive or language impairment that would make complying with the study protocol challenging 14. Excessive caffeine consumption, i.e., consumption higher than 8 cups of standard caffeinated drinks (tea, instant coffee) or higher than 6 cups of stronger coffee or other drinks containing methylxanthines such as Coca-Cola or Red Bull per day 15. Smoking >10 cigarettes per day; or equivalent nicotine consumption 16. Participant who is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Chief Investigator. 17. Inability to ingest up to 95mg of lactose 18. Previous or current use of gender-affirming hormonal treatment 19. Allergy to scopolamine or other anticholinergic medication (e.g. atropine, hyoscyamine) 20. History of urinary retention or bladder obstruction 21. Current use of antihistamines, antipsychotics, antidepressants, linezolid, domperidone and metoclopramide or amantadine or any other medication which, in the opinion of the Investigator may interfere with the safety of the participant or the scientific integrity of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Affective memory performance, assessed using the Emotional Recall (EREC) and Emotional Recognition Memory (EMEM) tasks from the Emotional Testing Battery (ETB). Performance will be measured approximately 60 minutes after oral administration of scopolamine (0.6 mg) or placebo, capturing accuracy, reaction times, and emotional bias in recall and recognition of affectively valenced words. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Facial expression recognition measured using accuracy and reaction times on the Facial Expression Recognition Task (FERT) 1–2 hours post-administration of scopolamine (0.6 mg) or placebo. 2. Categorization of emotionally valenced personality descriptor words, measured using performance on the Emotional Categorization Task (ECAT) 1–2 hours post-administration. 3. Response inhibition under emotional and non-emotional distraction, measured using accuracy and reaction times on the Emotional Go/No-Go Task (EGNG) 1–2 hours post-administration. 4. Reward-based learning and reversal, measured using choice behaviour and reaction times on the Probabilistic Reversal Learning Task (PRL) 1–2 hours post-administration. 5. Verbal learning and memory measured accuracy on the Auditory Verbal Learning Task (AVLT) 1–2 hours post-administration. 6. Working memory, measured using accuracy and reaction times on the N-Back Task 1–2 hours post-administration. 7. Digit span performance measured using maximum sequence length recalled on the Digit Span Task (DST) 1–2 hours post-administration. 8. Heart rate measured using an automated blood-pressure monitor at baseline and hourly post-administration as a physiological index of drug effect. 9. Subjective state measured using self-report questionnaires at baseline, 1 hour, and 2 hours post-administration. | — |
Countries
England, United Kingdom
Contacts
Public ContactFinley Watton
Outcome results
None listed