Healthy Volunteers Clinical Trial
— ModCogOfficial title:
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | September 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 16 Years to 40 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | Department of Psychiatry, Cambridge School of Clinical Medicine | Cambridge | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
Cambridge University Hospitals NHS Foundation Trust |
United Kingdom,
Flaherty AW. Frontotemporal and dopaminergic control of idea generation and creative drive. J Comp Neurol. 2005 Dec 5;493(1):147-53. Review. — View Citation
Minzenberg MJ, Carter CS. Modafinil: a review of neurochemical actions and effects on cognition. Neuropsychopharmacology. 2008 Jun;33(7):1477-502. Epub 2007 Aug 22. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | VAS | 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. | Baseline and hourly measure for 4 hours | No |
Primary | 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 | No |
Secondary | Physiological measures | 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. | Baseline and hourly observation for 4 hours | Yes |
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