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

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

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