Single-dose Potassium Supplementation in Patients With ADHD for Whom the Anesthetic Lidocaine is Ineffective
NCT ID: NCT03563573
Last Updated: 2018-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2018-07-01
2018-12-31
Brief Summary
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Detailed Description
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Each subject will be tested for lidocaine effectiveness using the application of lidocaine gel to the tongue and assessment by taste.
The subjects will then be assigned to two arms, (1) lidocaine sensitive (effective) or (2) lidocaine insensitive (ineffective), and then randomized as to an intervention of potassium supplementation or a placebo.
Each subject will:
* Complete questionnaires about their history of certain symptoms and a food diary.
* Get an ECG to exclude those with arrhythmias.
* Have their baseline serum potassium tested
* Have measures of ADHD symptoms performed.
Then each subject will receive the intervention of a single dose of the potassium or placebo.
After the wait of one hour, a repeat serum potassium and measurement of symptoms will be performed.
Note; The FDA also requires a Columbia Suicide Severity Rating Scale (C-SSRS) for all ADHD trials
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The investigators will adopt an iterative approach of testing of batches of subjects because (1) the frequency of lidocaine-insensitivity is only known approximately, (2) the frequency may be unevenly distributed across ethnic groups, and (3) the exact effect size of the potassium is not known, though reported to be high in off-label use in clinical settings with more chronic administration.
At the end of testing 40 patients, the results will be analyzed for statistical significance. (1) If the results are statistically significant with a 95% confidence, the testing may stop with the first batch of 40 subjects. (2) If not, sequential, iterative batches of 20 subjects will be tested, and the results reanalyzed.
TREATMENT
QUADRUPLE
Study Groups
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Lidocaine-effective ADHD: Intervention
Single-dose potassium gluconate oral capsule intervention for ADHD subjects for whom lidocaine is effective
Potassium Gluconate Oral Capsule
Each subject will receive a dose of \~8 mg/kg of potassium. We will be giving a maximum of 14 mEq in a single dose.
Lidocaine-effective ADHD: Placebo
Single-dose placebo oral capsule intervention for ADHD subjects for whom lidocaine is effective
Placebo oral capsule
Each subject will receive a dose of \~8 mg/kg of a placebo capsule
Lidocaine-ineffective ADHD: Intervention
Single-dose potassium gluconate oral capsule intervention for ADHD subjects for whom lidocaine is ineffective
Potassium Gluconate Oral Capsule
Each subject will receive a dose of \~8 mg/kg of potassium. We will be giving a maximum of 14 mEq in a single dose.
Lidocaine-ineffective ADHD: placebo
Single-dose placebo oral capsule intervention for ADHD subjects for whom lidocaine is ineffective
Placebo oral capsule
Each subject will receive a dose of \~8 mg/kg of a placebo capsule
Interventions
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Potassium Gluconate Oral Capsule
Each subject will receive a dose of \~8 mg/kg of potassium. We will be giving a maximum of 14 mEq in a single dose.
Placebo oral capsule
Each subject will receive a dose of \~8 mg/kg of a placebo capsule
Eligibility Criteria
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Inclusion Criteria
2. Untreated or taking existing ADHD drugs, but symptoms poorly controlled (e.g., symptoms not well managed by amphetamines, including ongoing inattention and impulsivity)
Exclusion Criteria
2. Epilepsy
3. IQ less than 80
4. Severe head trauma that led to loss of consciousness for more than an hour or required surgery
5. Birth weight below 5 pounds or 2270 grams
6. Severe autism (milder conditions described as Asperger syndrome or "high-functioning autism" are not excluded)
7. Comorbid psychiatric disorders, such as generalized anxiety disorder, major depressive disorder, schizophrenia and schizoaffective disorder, bipolar disorder, and any co-morbid condition at the discretion of the PI that would interfere with a patient's ability to participate
8. Mouth lesions, known to temporarily interfere with lidocaine effectiveness
9. Renal disease or abnormal kidney function or receiving dialysis
10. An individual has a factor likely to reduce penetrance, including excessive salt loss, such as caked salt on the body after exercise and Cystic fibrosis in a relative suggestive of the individual being a carrier.
11. Heart arrhythmia, known or evident on ECG
12. Known intolerance or allergy to lidocaine
13. Already taking supplemental potassium or renin angiotensin aldosterone inhibitors or other potassium elevating agents (see list below)
Angiotensin Converting Enzyme Inhibitors
1. Alacepril (not available in US)
2. Benazepril (Lotensin)
3. Captopril (trade name Capoten)
4. Cilazapril (Inhibace)
5. Delapril (not available in US)
6. Enalapril (Vasotec/Renitec)
7. Fosinopril (Fositen/Monopril)
8. Imidapril (Tanatril)
9. Lisinopril (Listril/Lopril/Novatec/Prinivil/Zestril)
10. Moexipril (Univasc)
11. Perindopril (Coversyl/Aceon/Perindo)
12. Quinapril (Accupril)
13. Ramipril (Altace/Prilace/Ramace/Ramiwin/Triatec/Tritace)
14. Spirapril (Renormax)
15. Temocapril (not available in US)
16. Teprotide (but not active by oral administration and not used in US)
17. Trandolapril (Mavik/Odrik/Gopten)
18. Zofenopril
Angiotensin receptor blockers
1. Azilsartan (Edarbi)
2. Candesartan (Atacand)
3. Eprosartan (Teveten)
4. Fimasartan (Kanarb)
5. Irbesartan (Avapro)
6. Losartan (Cozaar)
7. Olmesartan (Benicar/Olmetec)
8. Telmisartan (Micardis)
9. Valsartan (Diovan)
Aldosterone antagonists
1. Spironolactone (Aldactone)
2. Eplerenone (Inspra)
Renin inhibitors
a. Aliskiren (Tekturna, Rasilez)
Other potassium elevating agents
1. Antibiotics, including penicillin G and trimethoprim
2. Azole antifungals
3. Beta-blockers
4. Herbal supplements, including milkweed, lily of the valley, Siberian ginseng, Hawthorn berries
5. Heparin
6. Nonsteroidal anti-inflammatory medications (NSAIDs)
7. Oral contraceptives containing drospirenone
13 Years
49 Years
ALL
No
Sponsors
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AlkaliDx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael M Segal, MD PhD
Role: PRINCIPAL_INVESTIGATOR
PhenoSolve, LLC
Mark Mintz, MD
Role: PRINCIPAL_INVESTIGATOR
CNNH & CRCNJ
Locations
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Clinical Research Center of New Jersey (CRCNJ)
Voorhees Township, New Jersey, United States
Countries
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References
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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.
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.
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.
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.
Segal MM, Rogers GF, Needleman HL, Chapman CA. Hypokalemic sensory overstimulation. J Child Neurol. 2007 Dec;22(12):1408-10. doi: 10.1177/0883073807307095.
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.
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.
Related Links
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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, 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
Other Identifiers
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2017-01A
Identifier Type: -
Identifier Source: org_study_id
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