Clinical trial NCT04167189: Observational Study to Assess the Frequency of Lidocaine Ineffectiveness in Hard-to-treat ADHD
Official title: Prevalence of Lidocaine Ineffectiveness in Those With Hard-to-treat ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: ADHD
Lead sponsor: PhenoSolve, LLC
Sponsor class: INDUSTRY
Collaborators: name: NeurAbilities (formerly CRCNJ)
First posted: 2019-11-18
Enrollment: 28
Sex: ALL
Minimum age (years): 7
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Using a taste-based test before and after the application of lidocaine gel to the tongue, we will assess the degree to which lidocaine is effective at blocking taste in those with hard-to-treat ADHD
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Eligibility 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.

Primary outcomes:
measure: Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD
timeFrame: on day of testing, approximately 30 minutes for clinic visit
Secondary outcomes:
Other outcomes:
Locations:
city: Voorhees
country: United States
facility: NeurAbilitis
state: New Jersey
Study officials:
affiliation: PhenoSolve, LLC
name: Michael Segal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Levitt JO. Practical aspects in the management of hypokalemic periodic paralysis. J Transl Med. 2008 Apr 21;6:18. doi: 10.1186/1479-5876-6-18.
citation: Nakai Y, Milgrom P, Mancl L, Coldwell SE, Domoto PK, Ramsay DS. Effectiveness of local anesthesia in pediatric dental practice. J Am Dent Assoc. 2000 Dec;131(12):1699-705. doi: 10.14219/jada.archive.2000.0115.
citation: Segal MM. We cannot say whether attention deficit hyperactivity disorder exists, but we can find its molecular mechanisms. Pediatr Neurol. 2014 Jul;51(1):15-6. doi: 10.1016/j.pediatrneurol.2014.04.014. Epub 2014 Apr 18. No abstract available.
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.