Observational Study to Assess the Frequency of Lidocaine Ineffectiveness in Hard-to-treat ADHD
- Registration Number
- NCT04167189
- Lead Sponsor
- PhenoSolve, LLC
- Brief Summary
This work will assess the prevalence in hard-to-treat ADHD of the ineffectiveness of the anesthetic Lidocaine.
- Detailed Description
Using a non-invasive, pain-free, taste-based approach to assess lidocaine effectiveness, the study will assess the frequency of ineffectiveness in the target population.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
ADHD
Exclusion Criteria for both arms:
- known adverse reactions to lidocaine
- epilepsy, IQ <80, severe head trauma, birth weight <2270 grams, and severe autism;
- treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers;
- generalized anxiety disorders (but dental-specific anxiety will not be an exclusion because many of these individuals may be ones with anxiety because of painful dental experiences with lidocaine ineffectiveness);
- mouth sores;
- Ehlers Danlos syndrome, and
- red hair.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Observational study of prevalence in hard-to-treat ADHD Lidocaine gel Subjects will be tested with lidocaine gel.
- Primary Outcome Measures
Name Time Method Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD on day of testing, approximately 30 minutes for clinic visit Subjects will be asked to identify each taste and its intensity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
NeurAbilitis
🇺🇸Voorhees, New Jersey, United States