Clinical trial NCT03676725: Prevalence of Lidocaine Ineffectiveness in Adults With and Without ADHD
Official title: Assessing the Frequency of Lidocaine Ineffectiveness in the General Population vs. Males With ADHD, and Females With ADHD, With or Without PMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: ADHD
PMS
Lead sponsor: PhenoSolve, LLC
Sponsor class: INDUSTRY
Collaborators: name: Jacobi Medical Center
name: Boston Clinical Trials
First posted: 2018-09-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A group of 100 subjects will be assessed.
Primary purpose: HEALTH_SERVICES_RESEARCH

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..

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Lidocaine Ineffectiveness
timeFrame: 30 minute visit, added on to a regular clinic visit
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Clinical Trials
state: Massachusetts
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
Study officials:
affiliation: PhenoSolve, LLC
name: Michael Segal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Segal MM, Rogers GF, Needleman HL, Chapman CA. Hypokalemic sensory overstimulation. J Child Neurol. 2007 Dec;22(12):1408-10. doi: 10.1177/0883073807307095.
citation: Segal MM, Douglas AF. Late sodium channel openings underlying epileptiform activity are preferentially diminished by the anticonvulsant phenytoin. J Neurophysiol. 1997 Jun;77(6):3021-34. doi: 10.1152/jn.1997.77.6.3021.
citation: Teicher MH, Polcari A, Fourligas N, Vitaliano G, Navalta CP. Hyperactivity persists in male and female adults with ADHD and remains a highly discriminative feature of the disorder: a case-control study. BMC Psychiatry. 2012 Nov 7;12:190. doi: 10.1186/1471-244X-12-190.
citation: Mintz M, Badner V, Feldman LK, Mintz P, Saraghi M, Diaz J, Mezhebovsky I, Axelrod I, Gleeson J, Liu C, Smith C, Chow H, Zurakowski D, Segal MM. Lidocaine Ineffectiveness Suggests New Psychopharmacology Drug Target. Psychopharmacol Bull. 2022 Jun 27;52(3):20-30.