Neurochemical Modulation Cognitive Performance and Subjective Wellbeing In Healthy Controls
NCT ID: NCT02051153
Last Updated: 2014-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2009-10-31
2011-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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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.
Placebo
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
Modafinil
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).
Interventions
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Modafinil
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).
Placebo
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
16 Years
40 Years
ALL
Yes
Sponsors
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Cambridge University Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Dr Ahmed Dahir Mahmed
Chartered Psychologist
Locations
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Department of Psychiatry, Cambridge School of Clinical Medicine
Cambridge, Cambridgeshire, United Kingdom
Countries
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References
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Randall DC, Viswanath A, Bharania P, Elsabagh SM, Hartley DE, Shneerson JM, File SE. Does modafinil enhance cognitive performance in young volunteers who are not sleep-deprived? J Clin Psychopharmacol. 2005 Apr;25(2):175-9. doi: 10.1097/01.jcp.0000155816.21467.25.
Volkow ND, Fowler JS, Logan J, Alexoff D, Zhu W, Telang F, Wang GJ, Jayne M, Hooker JM, Wong C, Hubbard B, Carter P, Warner D, King P, Shea C, Xu Y, Muench L, Apelskog-Torres K. Effects of modafinil on dopamine and dopamine transporters in the male human brain: clinical implications. JAMA. 2009 Mar 18;301(11):1148-54. doi: 10.1001/jama.2009.351.
Turner DC, Clark L, Dowson J, Robbins TW, Sahakian BJ. Modafinil improves cognition and response inhibition in adult attention-deficit/hyperactivity disorder. Biol Psychiatry. 2004 May 15;55(10):1031-40. doi: 10.1016/j.biopsych.2004.02.008.
Flaherty AW. Frontotemporal and dopaminergic control of idea generation and creative drive. J Comp Neurol. 2005 Dec 5;493(1):147-53. doi: 10.1002/cne.20768.
Minzenberg MJ, Carter CS. Modafinil: a review of neurochemical actions and effects on cognition. Neuropsychopharmacology. 2008 Jun;33(7):1477-502. doi: 10.1038/sj.npp.1301534. Epub 2007 Aug 22.
Mohamed AD, Sahakian BJ. The ethics of elective psychopharmacology. Int J Neuropsychopharmacol. 2012 May;15(4):559-71. doi: 10.1017/S146114571100037X. Epub 2011 Mar 14.
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.
Other Identifiers
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A091967
Identifier Type: OTHER
Identifier Source: secondary_id
A091967
Identifier Type: -
Identifier Source: org_study_id