L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD
Recruiting · NCT07189442 · Interventional (participants receive a specific treatment) · Lead sponsor: Texas Tech University Health Sciences Center
View the official record on ClinicalTrials.gov →Interventions studied
L-theanine and paraxanthinePlacebo
What this trial is about
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 take part
Age range
No age limits stated
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 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
- 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.
Where it is running
1 location listed across 1 US state.
- Texas Tech University - Lubbock, Texas, United States