Clinical trial NCT02051153: Neurochemical Modulation Cognitive Performance and Subjective Wellbeing In Healthy Controls
Official title: Neurochemical Modulation Cognitive Performance and Subjective Wellbeing In Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance
Creativity
Motivation
Reward
Healthy Volunteers
Subjective Pleasure
Keywords: Modafinil
Cognitive
Performance
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 64
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Participants who do not meet the Exclusion Criteria

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Neuropsychological measures
timeFrame: 2 hours post drug administration
Secondary outcomes:
measure: Physiological measures
timeFrame: Baseline and hourly observation for 4 hours
Other outcomes:
measure: VAS
timeFrame: Baseline and hourly measure for 4 hours
Locations:
city: Cambridge
country: United Kingdom
facility: Department of Psychiatry, Cambridge School of Clinical Medicine
state: Cambridgeshire
Study officials:
References:
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citation: Mohamed AD, Lewis CR. Modafinil increases the latency of response in the Hayling Sentence Completion Test in healthy volunteers: a randomised controlled trial. PLoS One. 2014 Nov 12;9(11):e110639. doi: 10.1371/journal.pone.0110639. eCollection 2014.