Neurochemical Modulation Cognitive Performance and Subjective Wellbeing In Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Neuropsychological measures
研究概览
简要总结
This project aims to investigate the effect of modafinil on motivation, creativity, cognitive performance, and subjective wellbeing in healthy participants. The main task for this research project is to address how this novel stimulant acutely influences motivation, divergent and convergent thinking, cognitive performance and subjective wellbeing in non-sleep deprived healthy young adults.This is a randomised between-subjects parallel group design study.
Based on the hypothesis that psychostimulants might enhance creativity through the increase in of dopamine and executive planning in healthy adults , we predict that healthy individuals who are in the modafinil condition will perform better in the motivation, creativity, and the cognitive performance tasks. Furthermore, based on the evidence that modafinil increases dopamine in the nucleus accumbens, putamen and the caudate, we expect specific subjective well-being and pleasure enhancement associated with modafinil use in healthy young adults.
详细描述
Detailed Description:
Sixty Four healthy participants will attend one session at the Wellcome Trust Clinical Research Facility (WTCRF) during which they will be tested on objective measures of divergent and convergent thinking tasks, a computerised neuropsychological battery including tasks of motivation, and on well validated questionnaires about subjective wellbeing and salience of pleasure. Participants will be randomly allocated to one group and will receive either one dose of modafinil (200mg) or a placebo prior to testing.
Participants Sixty-four healthy volunteers will be identified via the City of Cambridge participant panel, and via local advertisements. Participants between the ages of 18-40 years will be chosen to avoid any effects of cognitive decline. The larger age range will be chosen to be representative of a wide range of ages and socio-economic statuses. A chartered psychologist will screen all volunteers.
After participants are assessed by the team, they then will complete a baseline physiological measures (blood pressure and pulse) and the National Adult Reading Test (NART) which calculates pre-morbid IQ estimates and matches participants' level of verbal IQ. Participants will then be given a single oral dose (200 mg) of modafinil or placebo with a small glass of water. They will then be asked to rest in a quiet room. Two hours post-drug administration, participants will also complete the computerised neuropsychological battery including the motivational reinforcement cue task and the salience of pleasure task in the form of visual analogue scale (VAS) on a computer screen. The VAS will measure the subjective pleasure gained from completing the computerised tasks and in participating in the study. After the completion of the study, participants will be debriefed by the researcher and will be discharged by a research nurse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who do not meet the Exclusion Criteria
排除标准
- •Participants will be excluded if they have any significant psychiatric history, visual or motor impairment, or the concurrent use of any psychotropic medications or any medication contra-indicated with modafinil. In addition, participants with a history of hypertension, cardiac disorders, epilepsy, and drug or alcohol abuse will also be excluded. All participants will be advised not to consume alcohol or caffeine for 12 hours before the testing sessions. All participants will be questioned about compliance with alcohol and caffeine restrictions before inclusion into the study.
研究组 & 干预措施
Placebo
Placebo: study participants received, in a double blind fashion, either a single dose (100 mg) of modafinil or a placebo pill identical to the drug.
Other Names: Placebo.
干预措施: Placebo (Drug)
Modafinil
Study participants received, in a double blind fashion, either a single dose (200 mg) of modafinil or a placebo pill identical to the drug.
Other Names:
Provigil
干预措施: Modafinil (Drug)
结局指标
主要结局
Neuropsychological measures
时间窗: 2 hours post drug administration
The cognitive measures used in this work will be drawn from the Cambridge Neuropsychological Test Automated Battery (CANTAB) battery and the from the Cued Reinforcement Reaction Task (CRRT): Participants will be assessed on the computerised neuropsychological tests and subjective questionnaires 2 hours post drug administration for 2 hour period in one study session. Outcome measures are: Errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores, and stages completed and strategy score. The percentage of correct trials and latency (speed of participant's response) will be calculated. For the span, scores for both the forwards and backwards tests were summed to yield an overall span score. For the CRRT participants' responses and reaction times will be recorded. Mean change in Subjective Well-being and subjective pleasure between 1, 2, 3, 4 hours will be calculated.
次要结局
- Physiological measures(Baseline and hourly observation for 4 hours)
研究者
Dr Ahmed Dahir Mahmed
Chartered Psychologist
Cambridge University Hospitals NHS Foundation Trust