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Prevalence of Lidocaine Ineffectiveness in Adults With and Without ADHD

Primary Purpose

ADHD, PMS

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Lidocaine gel

About this trial

This is an interventional health services research trial for ADHD

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Boston Clinical Trials
Jacobi Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

All subjects get the lidocaine taste test

Outcomes

Primary Outcome Measures

Number of Subjects With Lidocaine Ineffectiveness

Subjects will be asked to identify each taste and its intensity on a 0 (no taste) to 10 (very intense) scale before and after application of Lidocaine. Lidocaine effectiveness was quantitated as the reduction or elimination of taste by lidocaine compared to taste scores reported before lidocaine. For each of the four before/after pairs, the change in taste intensity was calculated, a weighted average score was computed. Incorrectly identified tastes were excluded. Scores of a reduction in taste ≥50% were considered to be lidocaine effective.

Secondary Outcome Measures

Full Information

NCT ID

NCT03676725

First Posted

September 17, 2018

Last Updated

September 30, 2022

Sponsor

PhenoSolve, LLC

Collaborators

Jacobi Medical Center, Boston Clinical Trials

1. Study Identification

Unique Protocol Identification Number

NCT03676725

Brief Title

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

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

August 14, 2019 (Actual)

Primary Completion Date

March 1, 2020 (Actual)

Study Completion Date

March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PhenoSolve, LLC

Collaborators

Jacobi Medical Center, Boston Clinical Trials

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ADHD, PMS

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

A group of 100 subjects will be assessed.

Masking

None (Open Label)

Masking Description

The scoring of the lidocaine test is masked, using the coded identity of the tastes. The tastes will be assessed in random order. The subjects and other study personnel will be told not to discuss what the subject could or couldn't taste. Scoring will not be shared with the testing site until all testing is complete.

Allocation

N/A

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All subjects

Arm Type

Experimental

Arm Description

All subjects get the lidocaine taste test

Intervention Type

Drug

Intervention Name(s)

Lidocaine gel

Other Intervention Name(s)

Intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Subjects With Lidocaine Ineffectiveness

Description

Time Frame

30 minute visit, added on to a regular clinic visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Segal, MD PhD

Organizational Affiliation

PhenoSolve, LLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston Clinical Trials

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02131

Country

United States

Facility Name

Jacobi Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We plan to submit for publication descriptions of what was accomplished, and the evaluations as described in the study, including the incidence of lidocaine ineffectiveness in those with ADHD and in the general population.

IPD Sharing Time Frame

9-12 months

IPD Sharing Access Criteria

Researchers

IPD Sharing URL

https://phenosolve.com

Citations:

PubMed Identifier

25447751

Citation

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.

Results Reference

background

PubMed Identifier

18426576

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.

Results Reference

background

PubMed Identifier

11143733

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.

Results Reference

background

PubMed Identifier

24938135

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.

Results Reference

background

PubMed Identifier

18174562

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.

Results Reference

background

PubMed Identifier

9212254

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.

Results Reference

background

PubMed Identifier

23134619

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.

Results Reference

background

PubMed Identifier

35815177

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.

Results Reference

derived

Links:

URL

https://www.amazon.com/ADHD-Does-Not-Exist-Hyperactivity/dp/006226673X

Description

Saul R (2014) "ADHD Does Not Exist". HarperCollins

URL

https://pdfs.semanticscholar.org/1778/f693dc7dd257ab98a96b5bf03408d9cef3eb.pdf

Description

Rozanski RJ, Primosch RE, Courts FJ (1988). Clinical efficacy of 1 and 2% solutions of lidocaine. Pediatr Dent.10:287-90

URL

https://www.uni-ulm.de/fileadmin/website_uni_ulm/med.inst.040/Dokumente/owner.html

Description

Segal MM, Jurkat-Rott K, Levitt J, Lehmann-Horn F (2014) Hypokalemic periodic paralysis - an owner's manual

URL

https://patents.google.com/patent/WO2017035470A1/en

Description

Segal MM (2015) Devices, Kits, and Methods for Determining Sensitivity to Anesthetics. US Patent Filing 62/210,747, Filed 09/14/2015

URL

https://clinicaltrials.gov/ct2/show/NCT03563573

Description

Companion study

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Prevalence of Lidocaine Ineffectiveness in Adults With and Without ADHD

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