Healthy Volunteers Clinical Trial
Official 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.
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.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05029518 -
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
|
Phase 1 | |
Completed |
NCT05001152 -
Taste Assessment of Ozanimod
|
Phase 1 | |
Completed |
NCT04493255 -
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
|
Phase 1 | |
Completed |
NCT03457649 -
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00995891 -
Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
|
||
Completed |
NCT05050318 -
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
|
Phase 4 | |
Completed |
NCT05043766 -
Evaluation of Oral PF614 Relative to OxyContin
|
Phase 1 | |
Completed |
NCT04466748 -
A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT00746733 -
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
|
Phase 1 | |
Recruiting |
NCT05929651 -
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
|
Phase 4 | |
Completed |
NCT05954039 -
Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect
|
N/A | |
Completed |
NCT05045716 -
A Study of Subcutaneous Lecanemab in Healthy Participants
|
Phase 1 | |
Active, not recruiting |
NCT02747927 -
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
|
Phase 3 | |
Completed |
NCT05533801 -
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
|
Phase 1 | |
Not yet recruiting |
NCT03931369 -
Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)
|
Phase 2 | |
Completed |
NCT03279146 -
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
|
Phase 1 | |
Completed |
NCT06027437 -
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
|
Phase 1 | |
Recruiting |
NCT05619874 -
Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity
|
N/A | |
Completed |
NCT05553418 -
Investigational On-body Injector Clinical Study
|
N/A | |
Completed |
NCT04092712 -
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
|
Phase 1 |