Single-dose Potassium Supplementation in Patients With ADHD for Whom the Anesthetic Lidocaine is Ineffective
Status unconfirmed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: ADHD
In brief
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.
Key facts
- Study ID
- NCT03563573
- Run by
- AlkaliDx, Inc.
- People needed
- 100
- Starts
- 2018-07-01
- Expected to finish
- 2018-12-31
- Last updated by the study team
- 2018-06-20
Who can join
Age: 13 and older, up to 49. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Previously documented ADHD diagnosis
- Untreated or taking existing ADHD drugs, but symptoms poorly controlled (e.g., symptoms not well managed by amphetamines, including ongoing inattention and impulsivity)
You may not qualify if…
- Well treated with existing ADHD medication
- Epilepsy
- IQ less than 80
- Severe head trauma that led to loss of consciousness for more than an hour or required surgery
- Birth weight below 5 pounds or 2270 grams
- Severe autism (milder conditions described as Asperger syndrome or "high-functioning autism" are not excluded)
- 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
- Mouth lesions, known to temporarily interfere with lidocaine effectiveness
- Renal disease or abnormal kidney function or receiving dialysis
- 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.
- Heart arrhythmia, known or evident on ECG
- Known intolerance or allergy to lidocaine
- Already taking supplemental potassium or renin angiotensin aldosterone inhibitors or other potassium elevating agents (see list below)
- Angiotensin Converting Enzyme Inhibitors
- Alacepril (not available in US)
- Benazepril (Lotensin)
- Captopril (trade name Capoten)
- Cilazapril (Inhibace)
- Delapril (not available in US)
- Enalapril (Vasotec/Renitec)
- Fosinopril (Fositen/Monopril)
- Imidapril (Tanatril)
- Lisinopril (Listril/Lopril/Novatec/Prinivil/Zestril)
- Moexipril (Univasc)
- Perindopril (Coversyl/Aceon/Perindo)
Where it is running
- Clinical Research Center of New Jersey (CRCNJ) — Voorhees Township, New Jersey, United States
Full record on ClinicalTrials.gov
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