Neurochemical Modulation Cognitive Performance and Subjective Wellbeing In Healthy Controls (ModCog)

NHS Foundation Trust

Status: Completed

Conditions: Motivation; Healthy Volunteers; Creativity; Cognitive Performance; Reward; Subjective Pleasure

Treatments: Drug: Placebo; Drug: Modafinil

Study type: Interventional

Funder types: Other

Identifiers

NCT02051153

A091967 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 16 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Modafinil

Experimental group

Description:

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

Treatment:

Drug: Modafinil