Neurochemical Modulation Cognitive Performance and Subjective Wellbeing In Healthy Controls

NCT02051153 | Completed DMC

• 1 other identifier: A091967
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Modafinil; Cognitive; Performance

Outcome Measures

Primary Outcomes (1)

• Neuropsychological measures

  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.

  2 hours post drug administration

Secondary Outcomes (1)

• Physiological measures

  Baseline and hourly observation for 4 hours

Other Outcomes (1)

• VAS

  Baseline and hourly measure for 4 hours

Study Arms (2)

Placebo

EXPERIMENTAL

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.

Drug: Placebo

Modafinil

EXPERIMENTAL

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

Drug: Modafinil

Interventions

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).

Also known as: Modafinil:

Modafinil

Placebo DRUG

Also known as: Drug: Placebo

Placebo

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Department of Psychiatry, Cambridge School of Clinical Medicine

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 15738750 BACKGROUND

• 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.

  PMID: 19293415 BACKGROUND

• 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.

  PMID: 15121488 BACKGROUND

• 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.

  PMID: 16254989 BACKGROUND

• 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.

  PMID: 17712350 BACKGROUND

• 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.

  PMID: 21396152 BACKGROUND

• 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.

  PMID: 25391155 DERIVED

MeSH Terms

Interventions

Modafinil

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chartered Psychologist

Study Record Dates

• First Submitted: January 29, 2014
• First Posted: January 31, 2014
• Study Start: October 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

GB (1)