Status:
NOT_YET_RECRUITING
L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD
Lead Sponsor:
Texas Tech University Health Sciences Center
Collaborating Sponsors:
Texas Tech University
Conditions:
Attention Deficit Hyperactivity Disorder (ADHD)
Autism Spectrum Disorder (ASD)
Eligibility:
MALE
Phase:
NA
Brief 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, s...
Detailed Description
Improving cognitive functions, including how fast the brain processes information, staying focused, and controlling impulsive actions, has been a topic of interest for centuries. These functions are f...
Eligibility Criteria
Inclusion
- Adults (18+ years) diagnosed by a physician (per self-report) with ADHD or ASD
- \* Participants with a dual diagnosis and ASD and ADHD will be recruited but will only be included in the ASD group - their concurrent ADHD diagnosis will be included as an additional variable in exploratory analyses
Exclusion
- 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
- 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
- Intake of drugs containing caffeine, other phosphodiesterase inhibitors, or adenosine receptor blockers within the past 3 months
- Intake of medications known to have pharmacological interactions with paraxanthine within the past 3 months
- Current/past diagnosis of tics or other forms of dyskinesia
- History of headache, drowsiness, anxiety, insomnia, or nausea following intake of caffeine or caffeine-containing beverages
- Current/past history of smoking and/or alcohol or drug abuse
- Subjects with absolute contraindications to undergo MRI after being screened by the TTNI safety screening sheet (Appendix)
- Unwillingness or inability to entirely refrain from the use of electronic devices during study visits
- Unwillingness or inability to follow written, on-screen, and verbal instructions given by the study team.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07189442
Start Date
October 1 2025
End Date
June 1 2026
Last Update
September 24 2025
Active Locations (1)
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1
Texas Tech University
Lubbock, Texas, United States, 79430