Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD

Completed · Phase 1 · Has a placebo group

Conditions studied: ADHD

In brief

Specific Aim 1: As part of a within-subject, two-days, study design, to determine whether acute calcitriol (vs. placebo) pre-treatment is associated with greater amphetamine (Amp)-induced dopamine (DA) release in the caudate, putamen, ventral striatum (VST), and substantia nigra / ventral tegmental area (SN/VTA) of healthy human subjects. Specific Aim 2: To determine whether acute calcitriol (vs. placebo) pre-treatment is associated with better performance on a test of attention (e.g., the Continuous Performance Task or CPT-IP), after treatment with amphetamine. Hypothesis: Investigators hypothesize that Subjects pre-treated with calcitriol will have faster reaction times/higher accuracy on the CPT-IP vs. subjects pre-treated with placebo, after treatment with amphetamine.

Key facts

Study ID

NCT03103750

Run by

Yale University

People needed

24

Starts

2017-08-15

Expected to finish

2023-01-17

Last updated by the study team

2024-03-19

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18-50 years
• Voluntary, written, informed consent
• Physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
• For females, non-lactating, with a negative serum or urine pregnancy test
• Lab results without clinically relevant findings (e.g. renal function, electrolytes, and vitamin D levels)
• English speaking

You may not qualify if…

• Medical contraindication to Dexedrine administration (e.g., history of cardiac problems, seizures, glaucoma, hypertension, hyperthyroidism, etc.)
• Medical contraindication to calcitriol administration (e.g., history of hypersensitivity to calcitriol or any component of the formulation, hypercalcemia or vitamin D toxicity)
• History of substance dependence (e.g., alcohol, opiates, sedative hypnotics), except for nicotine
• A primary major DSM-5 psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the Structured Clinical Interview for DSM-5 (SCID)
• A history of significant medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular accidents, seizure, traumatic brain injury) illness
• Positive answers on the cardiac history questionnaire that may place the subject at higher risk, as determined by an internal medicine specialist or cardiologist's review of both the questionnaire responses and screening ECG
• Current use of psychotropic and/or potentially psychoactive prescription medications
• For females, laboratory (β-HCG) or physical evidence of pregnancy/lactation 9) MRI-incompatible implants and other contraindications for MRI (i.e., aneurysm clip, metal fragments, internal electrical devices such as a cochlear implant, spinal cord stimulator or pacemaker)
• History of claustrophobia or feeling of inability to lie still on his/her back for the PET or MRI scans
• History of any bleeding disorder or current anticoagulant therapy
• Donation or loss of 550 mL of blood or more (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to the first test day.
• Use of any prescription medications and/or over-the-counter medications, vitamins and/or herbal supplements which could have a negative clinical interaction with calcitriol/Dexedrine or which could confound scientific results of the study, within 2 weeks prior to each test day (e.g., thiazide diuretics, Mg based antiacids, digoxin, etc,.).
• Serum levels of 25(OH)D3 below 20 ng/ml.
• Obesity i.e. BMI over 30 (more prone to lower vitamin D levels)
• Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over Radioactive Drug Research Committee (RDRC) limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year.
• Subjects with current, past or anticipated exposure to radiation in the work place
• History of kidney stones within the past 5 years
• Any degree of renal failure
• History of parathyroid disorder (hyper or hypoparathyroidism)
• History of osteoporosis or any pathologic fractures
• Vitamin D supplementation in any form in the past 3 months
• Known hypersensitivity to Dexedrine, [11C]PHNO, or calcitriol
• Malabsorption syndromes (i.e. Celiac sprue)
• Serum corrected calcium > 10.5 mg/dl or phosphate > 4.2 mg/dl

Where it is running

• Connecticut Mental Health Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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