Status:
RECRUITING
Differences by Sex and Genotype in the Effects of Stress on Executive Functions
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Stress
Eligibility:
All Genders
20-35 years
Phase:
PHASE1
Brief Summary
The aim of this project is to test the effects of an environmental factor (mild stress) on prefrontal cortex (PFC) and the cognitive functions that depend on PFC (collectively called executive functio...
Detailed Description
The investigators propose to test each young adult twice; once on the lowest clinically relevant dose of MPH and once on a placebo (Vitamin C), with the order counterbalanced. The two testing sessions...
Eligibility Criteria
Inclusion
- Between the ages of 20 and 35 years old
Exclusion
- a neurological impairment or disorder, learning disability, or psychological syndrome that might affect EF performance (such as ADHD)
- inability to understand the task instructions (which are in English), or difficulty hearing the instructions, seeing the stimuli, or executing a manual response.
- a serious adverse event during pregnancy or birth.
- an injury (such as a head injury with loss of consciousness) that might affect EF performance.
- a major trauma that might affect current EFs and stress responsivity
- undue current life stress level
- taking any medication that affects thinking, memory, mental clarity, or any other EF ability.
- taking any medication that influences circulating gonadal hormone levels (such as oral contraceptives \[birth control pill\]).
- having taken such medications within the preceding four months.
- smokers
- use of recreational drugs or consumption of alcohol 24 hours prior to the testing sessions
- women without a period that occurs roughly every month (predicting the onset of the next menses in women who don't have their period monthly is difficult)
- women who are pregnant or who are nursing.
- having the eye problem glaucoma
- having a heart condition
- being anxious, tense or agitated
- taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
- taking pressor agents (for hypotension treatment)
- taking coumarin anticoagulants
- taking anticonvulsants (phenobarbital, diphenylhydantoin, primidone)
- taking phenylbutazone (nonsteroidal anti-inflammatory drug)
- taking tricyclic antidepressants (imipramine, desipramine)
- taking cold or allergy medicine that contain decongestants
- being allergic to anything in either the MPH or Vitamin C capsules (methylphenidate HCL, ascorbic acid, lactose, gelatin, Titanium dioxide, D\&C Red #28, FD\&C Blue #1, FD\&C Red #40)
Key Trial Info
Start Date :
April 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04273880
Start Date
April 28 2018
End Date
December 1 2024
Last Update
May 8 2024
Active Locations (1)
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1
Developmental Cognitive Neuroscience Lab, Department of Psychiatry, University of British Columbia
Vancouver, British Columbia, Canada, V6T 2A1