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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04167189
• Other study ID #: 2019-01A
• Status: Completed
• Phase: Early Phase 1
• Start date: January 20, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: June 2021
• Source: PhenoSolve, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD

Intervention

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

Locations

Country	Name	City	State
United States	NeurAbilitis	Voorhees	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
PhenoSolve, LLC	NeurAbilities (formerly CRCNJ)

Country where clinical trial is conducted

United States, 

References & Publications (7)

Infante MA, Moore EM, Nguyen TT, Fourligas N, Mattson SN, Riley EP. Objective assessment of ADHD core symptoms in children with heavy prenatal alcohol exposure. Physiol Behav. 2015 Sep 1;148:45-50. doi: 10.1016/j.physbeh.2014.10.014. Epub 2014 Oct 23. — View 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. Erratum in: J Transl Med. 2014;12:198. Dosage error in article text. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observational Study: Number of Participants With Lidocaine Ineffectiveness by Taste Test in Hard-to-treat ADHD	Subjects will be asked to identify each taste and its intensity.	on day of testing, approximately 30 minutes for clinic visit

External Links

•   Companion study
•   Rozanski RJ, Primosch RE, Courts FJ (1988). Clinical efficacy of 1 and 2% solutions of lidocaine. Pediatr Dent.10:287-90
•   Saul R (2014) "ADHD Does Not Exist". HarperCollins
•   Segal MM (2015) Devices, Kits, and Methods for Determining Sensitivity to Anesthetics. US Patent Filing 62/210,747, Filed 09/14/2015
•   Segal MM, Jurkat-Rott K, Levitt J, Lehmann-Horn F (2014) Hypokalemic periodic paralysis - an owner's manual