Prevalence of Lidocaine Ineffectiveness in Adults With and Without ADHD

Early Phase 1

Completed

Conditions: PMS
ADHD

Interventions: Drug: Lidocaine gel

Registration Number: NCT03676725

Lead Sponsor: PhenoSolve, LLC

Brief Summary: 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: 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..

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	Lidocaine gel	All subjects get the lidocaine taste test

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Lidocaine Ineffectiveness	30 minute visit, added on to a regular clinic visit	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.

Secondary Outcome Measures