Overview

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

Status:
Unknown status

Trial end date:
2018-12-31

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

AlkaliDx, Inc.

Treatments:

Lidocaine

Criteria

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