Prevalence of Lidocaine Ineffectiveness in Adults With and Without ADHD

Study Overview
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Brief Summary
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This work will assess the prevalence in the general population of the ineffectiveness of the anesthetic Lidocaine compared to males with ADHD and females with ADHD with or without PMS.

Detailed Description
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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. We will use an identical protocol at two sites: Jacobi hospital and Boston Clinical Trials. The controlled trial will assess the ability of lidocaine oral gel to block taste (e.g., sweet) in 100 teens and adults, half with a history of ADHD, and for females, we will compare the sub-groups with and without premenstrual syndrome (PMS). This study will also be compared with a similar assessment among a specialized ADHD population (NCT03563573), that does not respond to existing medication..

Official Title
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Assessing the Frequency of Lidocaine Ineffectiveness in the General Population vs. Males With ADHD, and Females With ADHD, With or Without PMS

Conditions
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ADHD, PMS

Intervention / Treatment
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* Drug: Lidocaine gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Exclusion Criteria for both arms: (1) known adverse reactions to lidocaine; (2) ADHD, ADD, and other inattention disorders; (3) epilepsy, IQ <80, severe head trauma, birth weight <2270 grams, and severe autism; (4) treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers; (5) 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); (6) mouth sores; (7) Ehlers Danlos syndrome, (8) red hair, and (9) current pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: A group of 100 subjects will be assessed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All subjects<br>All subjects get the lidocaine taste test | Drug: Lidocaine gel<br>* Lidocaine gel (0.75 g premeasured dose of Septodont 5% oral gel NDC 0362-0221-10)<br>* Other names: Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Lidocaine Ineffectiveness | Subjects will be asked to identify each taste and its intensity on a 0 (no taste) to 10 (very intense) scale before and after application of Lidocaine. Lidocaine effectiveness was quantitated as the reduction or elimination of taste by lidocaine compared to taste scores reported before lidocaine. For each of the four before/after pairs, the change in taste intensity was calculated, a weighted average score was computed. Incorrectly identified tastes were excluded. Scores of a reduction in taste ≥50% were considered to be lidocaine effective. | 30 minute visit, added on to a regular clinic visit |