Skip to main content
OpenTrials
Completed

NCT Number: NCT04167189

Observational Study to Assess the Frequency of Lidocaine Ineffectiveness in Hard-to-treat ADHD

This work will assess the prevalence in hard-to-treat ADHD of the ineffectiveness of the anesthetic Lidocaine.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

7 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

NeurAbilitis

Voorhees Township, New Jersey, 08043, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine gel

Drug

Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg

Other names: Intervention

Primary outcomes

  1. Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD

    Time frame: on day of testing, approximately 30 minutes for clinic visit

    Subjects will be asked to identify each taste and its intensity.

Sponsors and collaborators

Lead sponsor

PhenoSolve, LLC

Industry

Collaborators

  • NeurAbilities (formerly CRCNJ)

Registry information

Official study title

Prevalence of Lidocaine Ineffectiveness in Those With Hard-to-treat ADHD

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 18, 2019
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.