NCT03676725

Prevalence of Lidocaine Ineffectiveness in Adults With and Without ADHD

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: PhenoSolve, LLC · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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..

Conditions

• ADHD
• PMS

Interventions

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

Timeline

• Start date: 2019-08-14
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2018-09-19
• Last updated: 2022-10-06
• Results posted: 2021-07-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study