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

Summary

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.

Conditions

• ADHD

Interventions

PROCEDURE

Magnetic Resonance Imaging (MRI)

Magnetic resonance imaging (MRI) scans (3 T) will be collected in each subject for the purposes of excluding participants with anatomical abnormalities and anatomically co-registering PET and MRI for image analysis

DRUG

PHNO

Used as a tracer for in vivo imaging.

DIETARY_SUPPLEMENT

calcitriol

three 0.5 mcg capsules

DRUG

Placebo oral capsule

three 0.5 mcg capsules

PROCEDURE

high-resolution research tomography

A functional imaging technique that is used to observe metabolic processes in the body.

DRUG

Dextro Amphetamine

Dexedrine 0.3 mg/kg, to a maximum dose of 30 mg

Sponsors & Collaborators

• Brain & Behavior Research Foundation

  collaborator OTHER

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• Marc Potenza, PhD, MD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-15

Primary Completion

2023-01-17

Completion

2023-01-17

FDA Drug

Yes

Countries

• United States

Study Locations