L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD (NCT07189442) | Clinical Trial Compass
RecruitingNot Applicable
L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD
United States24 participantsStarted 2025-10-01
Plain-language summary
This pilot study will test whether combining L-theanine and paraxanthine improves sustained attention, inhibitory control, and overall cognition in adults with ADHD and ASD. Two parallel randomized, single-blinded, repeated-measures crossover trials will be conducted. Participants will complete neuropsychological testing, fMRI scanning, and self-report measures following administration of the L-theanine-paraxanthine combination compared to placebo.
Who can participate
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Subjects with gross visual or auditory impairments that might limit their ability to perform neuropsychological tasks
. Inability to read and follow written instructions
. Physical, neurological, intellectual, or psychiatric impairments (except ADHD or ASD) that could affect cognitive and motor functions
. Subjects on medications including antidepressants and antipsychotics that may affect performance in the tasks
. Subjects on medications that are likely to interact with the administered substances, including regular intake of medication that could alter visual, auditory, cognitive, or motor functions (except stimulants)
. History of head injury resulting in loss of consciousness/history of brain surgery
. Subjects who have developed adverse effects when caffeine/paraxanthine /L-theanine/corn starch (will be in placebo) containing products were consumed
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
fMRI task-related activity
Timeframe: At visit 2 or 3, 30 minutes after intake of L-theanine-paraxanthine or placebo.
2
Stop Signal Reaction Time
Timeframe: At visit 2 or 3, 30 minutes after intake of L-theanine-paraxanthine or placebo. This task is performed while in the MRI.
3
d-prime (sensitivity to the Go signal)
Timeframe: At visit 2 or 3, 30 minutes after intake of L-theanine-paraxanthine or placebo. This task is performed while in the MRI.
Trial details
NCT IDNCT07189442
SponsorTexas Tech University Health Sciences Center
. Subjects who are unwilling or unable to refrain from intake of L-theanine/ caffeine/ paraxanthine containing food or beverages within the 24 hours prior to each study visit