Validating a New Non-invasive Approach to Testing Lidocaine Effectiveness

NCT03680885 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 2018-271
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This work will assess the reliability of a simple painless test for the effectiveness of the commonly used local anesthetic lidocaine

Conditions

ADHD; Controls

Keywords

Lidocaine ineffectiveness; ADHD; ADD

Outcome Measures

Primary Outcomes (2)

• Taste sensation after lidocaine or placebo

  The subject is blinded to the tastant and gel identities. The 3 tastants are tested in randomized order. After application of lidocaine gel or placebo to the tongue, and a wait of 2 minutes, the subject's tongue is rubbed with a swab that has been wet with the tastant on the subject's tongue. The subject is asked to identify the taste (e.g., sweet). Then, on a 5-point scale (0-4, ranging from none to very intense) they are asked to rate the intensity of the taste. The process is repeated for each of the three tastants. The consistency of the subject responses over the 4 sessions will be analyzed.

  4 visits each of 30 minutes within weeks of one another, average ~1 month total

• Ability to feel pressure and discomfort after injection of lidocaine into the cheek

  Inject lidocaine as would be done in a dental visit, assess numbness to pressure and discomfort using the Baker Wong FACES scale (0-10) scale of discomfort, ranging from none to intense pain. The effectiveness of lidocaine will be assessed, and then the results compared to Outcome 1.

  1 visit of 30 minutes after other 4 visits, average ~1 month total

Study Arms (2)

Reports getting numb at dentist

ACTIVE COMPARATOR

Subjects will be tested twice with lidocaine gel, twice with a Placebo and once with Injected Lidocaine to assess effectiveness of lidocaine. Each assessment will be on a different day.

Drug: Lidocaine gel; Drug: Placebo; Drug: Injected lidocaine

Reports trouble getting numb at dentist

ACTIVE COMPARATOR

Subjects will be tested twice with lidocaine gel, twice with a Placebo and once with Injected Lidocaine to assess effectiveness of lidocaine. Each assessment will be on a different day.

Drug: Lidocaine gel; Drug: Placebo; Drug: Injected lidocaine

Interventions

Lidocaine gel DRUG

Lidocaine gel 5%, PEG with FD\&C Blue No.1 (Brilliant Blue FCF)

Also known as: Intervention

Reports getting numb at dentist; Reports trouble getting numb at dentist

Placebo DRUG

PEG with FD\&C Blue No.1 (Brilliant Blue FCF)

Also known as: Control gel

Reports getting numb at dentist; Reports trouble getting numb at dentist

Injected lidocaine DRUG

Standard FDA-approved dental injectable lidocaine

Also known as: Current practice

Reports getting numb at dentist; Reports trouble getting numb at dentist

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Report "get numb at dentist"

You may not qualify if:

• ADHD, ADD, and other inattention disorders
• Known adverse reactions to lidocaine;
• Epilepsy
• IQ \<80
• Severe head trauma
• Birth weight \<2270 grams
• Severe autism
• Mouth sores
• Ehlers Danlos syndrome
• Red hair
• Current pregnancy
• Treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers
• Angiotensin Converting Enzyme Inhibitors
• Alacepril (not available in US)
• Benazepril (Lotensin)

Sponsors & Collaborators

• PhenoSolve, LLC: lead
• Jacobi Medical Center: collaborator

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Related 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.

  PMID: 25447751 RESULT

• 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.

  PMID: 18426576 RESULT

• 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.

  PMID: 11143733 RESULT

• 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.

  PMID: 24938135 RESULT

• Segal MM, Rogers GF, Needleman HL, Chapman CA. Hypokalemic sensory overstimulation. J Child Neurol. 2007 Dec;22(12):1408-10. doi: 10.1177/0883073807307095.

  PMID: 18174562 RESULT

• 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.

  PMID: 9212254 RESULT

• 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.

  PMID: 23134619 RESULT

Related Links

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

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methods

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Michael Segal, MD PhD

  PhenoSolve, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The scoring of the lidocaine test is masked, using the coded identity of the tastes. The tastes will be assessed in random order. Each subject will have 2 tests with lidocaine gel and 2 with a placebo gel, in random order, each on different days. The subjects and other study personnel will be told not to discuss what the subject could or couldn't taste. Scoring will be done only after all testing on the subject is complete. A person not involved in the testing will keep track of which gels the subject has had.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Half the subjects will have a self-reported history of lidocaine working for them (effective) and half will have a history of difficulty getting numb (ineffective).

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 21, 2018
• Study Start: August 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 9-12 months

Locations

US (1)