Skip to main content
OpenTrials
Completed

NCT Number: NCT02051153

Neurochemical Modulation Cognitive Performance and Subjective Wellbeing In Healthy Controls

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cognitive Performance Creativity Healthy Volunteers Motivation Reward Subjective Pleasure

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, Cambridge School of Clinical Medicine

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modafinil

Drug

Modafinil (2-[(Diphenylmethyl) sulfinyl]acetamide (Provigil, 1997)) is a novel drug which has a demonstrable efficacy in the treatment of daytime sleepiness associated with narcolepsy (Benerjee et al., 2004). Studies on healthy volunteers show that modafinil improves neuropsychological task performance in some healthy individuals (Turner et al., 2004; Baranski et al., 2004; MÜller et al., 2004; Randall et al., 2005) and in patients with neuropsychiatric disorders (Minzenberg & Carter, 2008).

Other names: Modafinil:

Placebo

Drug

Other names: Drug: Placebo

Primary outcomes

  1. Neuropsychological measures

    Time frame: 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.

Secondary outcomes

  1. Physiological measures

    Time frame: Baseline and hourly observation for 4 hours

    Blood pressure and pulse measurements will be taken using a Criticare Systems Inc. Comfort Cuff (Model 507NJ) at five time points: immediately upon arrival, before drug administration, immediately prior to testing (2 h post-drug), 1 h into testing (3 h post-drug), and on completion of the study (4 h post-drug). To monitor adverse events, this will measure number of participants on active and non-active agent with high or low blood pressure and plus. Outcome measure: Change from Baseline in Systolic Blood Pressure at Hour 1, 2, 3, and 4.

Other outcomes

  1. VAS

    Time frame: Baseline and hourly measure for 4 hours

    Participants will complete a visual analogue scales before administration of the drug (baseline) and at intervals during the testing session: immediately prior to testing (2 hours post dosing), 1 h into testing (3 hours post dosing) and on completion of testing (discharge) to measure subjective mood change.

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Registry information

Acronym: ModCog

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 31, 2014
Registry last updated
Jan 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.