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

PhenoSolve

Status and phase: Completed; Early Phase 1

Conditions: ADHD

Treatments: Drug: Lidocaine gel

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04167189

2019-01A

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 7 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: ADHD

Exclusion Criteria for both arms:

1. known adverse reactions to lidocaine
2. epilepsy, IQ <80, severe head trauma, birth weight <2270 grams, and severe autism;
3. treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers;
4. 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);
5. mouth sores;
6. Ehlers Danlos syndrome, and
7. red hair.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Observational study of prevalence in hard-to-treat ADHD

Other group

Description:

Subjects will be tested with lidocaine gel.

Treatment:

Drug: Lidocaine gel