Prevalence of Lidocaine Ineffectiveness in Adults With and Without ADHD

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-14

Study Completion Date

2020-03-01

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.

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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..

Conditions

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ADHD PMS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A group of 100 subjects will be assessed.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

The scoring of the lidocaine test is masked, using the coded identity of the tastes. The tastes will be assessed in random order. The subjects and other study personnel will be told not to discuss what the subject could or couldn't taste. Scoring will not be shared with the testing site until all testing is complete.

Study Groups

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All subjects

All subjects get the lidocaine taste test

Group Type EXPERIMENTAL

Lidocaine gel

Intervention Type DRUG

Lidocaine gel (0.75 g premeasured dose of Septodont 5% oral gel NDC 0362-0221-10)

Interventions

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Lidocaine gel

Lidocaine gel (0.75 g premeasured dose of Septodont 5% oral gel NDC 0362-0221-10)

Intervention Type DRUG

Other Intervention Names

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Intervention

Eligibility Criteria

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Exclusion Criteria

(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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes