Single-dose Potassium Supplementation in Patients With ADHD for Whom the Anesthetic Lidocaine is Ineffective

AlkaliDx

Status and phase: Unknown; Phase 2; Phase 1

Conditions: ADHD

Treatments: Drug: Potassium Gluconate Oral Capsule; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03563573

2017-01A

Details and patient eligibility

About

Randomized, controlled, double-blind trial of the effect of a single dose of potassium on ADHD symptoms as measured by changes in measures of symptoms of ADHD correlated with the results of their Lidocaine Effectiveness Test.

Full description

Subjects with a confirmed diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), who are either untreated or poorly controlled with existing ADHD therapy, will be recruited for a single, four-hour session.

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

Enrollment: 100 estimated patients

Sex: All

Ages: 13 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Previously documented ADHD diagnosis
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

1. Well treated with existing ADHD medication
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups, including a placebo group

Lidocaine-effective ADHD: Intervention

Active Comparator group

Description:

Single-dose potassium gluconate oral capsule intervention for ADHD subjects for whom lidocaine is effective

Treatment:

Drug: Potassium Gluconate Oral Capsule

Lidocaine-effective ADHD: Placebo

Placebo Comparator group

Description:

Single-dose placebo oral capsule intervention for ADHD subjects for whom lidocaine is effective

Treatment:

Drug: Placebo oral capsule

Lidocaine-ineffective ADHD: Intervention

Active Comparator group

Description:

Single-dose potassium gluconate oral capsule intervention for ADHD subjects for whom lidocaine is ineffective

Treatment:

Drug: Potassium Gluconate Oral Capsule

Lidocaine-ineffective ADHD: placebo

Placebo Comparator group

Description:

Single-dose placebo oral capsule intervention for ADHD subjects for whom lidocaine is ineffective

Treatment:

Drug: Placebo oral capsule