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New treatment option for Attention Deficit Hyperactivity Disorder (ADHD)
Official title L-theanine and Paraxanthine for Cognitive Improvement in Adults With ADHD and ASD
ClinicalTrials.gov ID: NCT07189442
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, men only
You may be able to join if
- 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...
You likely can't join if
- people 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
- people on medications including antidepressants and antipsychotics that may affect performance in the tasks
- people on medications that are likely to interact with the administered substances, including regular intake of medication that could alter visual...
- History of head injury resulting in loss of consciousness/history of brain surgery
See the full eligibility 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
- people 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
- people on medications including antidepressants and antipsychotics that may affect performance in the tasks
- people 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
- people who have developed adverse effects when caffeine/paraxanthine /L-theanine/corn starch (will be in placebo) containing products were consumed
- people 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
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Lubbock, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lubbock, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.