Healthy Clinical Trial
Official title:
Noradrenaline, Acetylcholine and Dynamic Learning in Healthy Humans
NCT number | NCT03957174 |
Other study ID # | R62807/RE001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2019 |
Est. completion date | June 1, 2020 |
Verified date | March 2020 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to characterize the role of central norepinephrine and acetylcholine on reward and emotion related information processing in healthy volunteers using behavioural tasks and pupillometry (with eye tracking equipment). The pharmacological compounds used in the study (reboxetine and rivastigmine) are used as tools to manipulate these systems rather than to treat patients. The aim of the study is not to study the clinical effects, pharmacodynamics, adverse reactions, absorption, distribution, metabolism or excretion of the drugs. Further, the population studied is non-clinical, the drugs are not administered in a therapeutic dosing regimen (only a single dose of study drug will be administered) and the investigators do not measure clinically significant outcomes.
Status | Completed |
Enrollment | 107 |
Est. completion date | June 1, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Male or female - Age: 18 to 45 years - Good physical and mental health - Participant is willing and able to give informed consent for participation in the study - Sufficient knowledge of English language to understand and complete study tasks - Willingness to refrain from driving, cycling, or operating heavy machinery on the day of the study Exclusion Criteria: - Current or past psychiatric disorder (e.g. depression, bipolar disorder etc.) - BMI outside of range 187.5 and 2530 - Any severe medical condition not stabilized at the time of the experiment that, in the opinion of the study medic, would compromise the safety or conduct of the study including significant hypertension (diastolic pressure > 100mmHg) or bradycardia (pulse less than 50 bpm). - Any history of seizures, glaucoma or pancreatitis - Lactose intolerance - Any current or past physical illness that has the potential to significantly affect mental functioning (e.g. epilepsy, hypothyroidism, Parkinson's disease, multiple sclerosis etc.) - Pregnant, or lactating woman - Sexually active woman who does not use any medically accepted method of contraception - Current or previous intake (last month) of any medication that has a significant potential to affect mental functioning (e.g. benzodiazepines, antidepressants, neuroleptics etc.) - Any intake of recreational drugs in the last 3 months (e.g. marijuana, ecstasy etc.) - Harmful alcohol use in the last 6 months (harmful alcohol use established based on self-reported work-related or social problems due to alcohol use or other's feedback to the participant that s/he should cut down) - History of allergic reactions to relevant substances (reboxetine, rivastigmine) - Previous participation in a study using the same or similar tasks - In the researcher's or study medic's opinion participation in the study could be harmful or severely distressing to the participant (e.g. intolerance of side effects) or the participant is not able to follow instructions or complete study tasks |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Dept of Psychiatry, University of Oxford | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in learning rates | Learning rates from negative and positive outcomes received in a reinforcement learning task | 2 hours after dosing (NB outcome is the change from the baseline measure to this time point) | |
Secondary | Pupil size | High temporal resolution pupil size measurement during a reinforcement learning task | 2 hours after dosing (NB outcome is the change from the baseline measure to this time point) | |
Secondary | Affective processing | Response accuracy in the Facial Emotion Recognition Task (FERT). | 2 hours after dose |
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