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calcitriol for Attention Deficit Hyperactivity Disorder (ADHD)

Phase 1
Waitlist Available
Led By Marc Potenza, PhD, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7
Awards & highlights

Study Summary

This trial is testing whether a vitamin D supplement can increase dopamine release and improve attention in healthy people after taking amphetamine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Non-displaceable Tracer Binding Potentials
Secondary outcome measures
Continuous Performance Task (CPT-IP)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo then CalcitriolExperimental Treatment6 Interventions
Healthy volunteers will receive a baseline MRI. On the night before and day of testing, subjects will receive two doses of placebo, followed by PHNO injection and PET Scan #1. After PET Scan #1, subjects will receive a Dexedrine dose, followed by PHNO injection and PET Scan #2. A minimum of six days later, subjects will receive two doses of calcitriol (3.0mcg total) for the night before and day of testing, followed by a third PHNO injection and PET scan #3. After PET scan #3, subjects will receive another Dexedrine dose, followed by PHNO injection and PET scan #4.
Group II: Calcitriol then placeboExperimental Treatment6 Interventions
Healthy volunteers will receive a baseline MRI. On the night before and day of testing, subjects will receive two doses of calcitriol (3.0mcg total), followed by PHNO injection and PET Scan #1. After PET Scan #1, subjects will receive a Dexedrine dose, followed by PHNO injection and PET Scan #2. A minimum of six days later, subjects will receive two doses of placebo for the night before and day of testing, followed by a third PHNO injection and PET scan #3. After PET scan #3, subjects will receive another Dexedrine dose, followed by PHNO injection and PET scan #4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
high-resolution research tomography
2017
Completed Phase 1
~30
Dextro Amphetamine
2017
Completed Phase 1
~30
Magnetic Resonance Imaging (MRI)
2015
Completed Phase 4
~1800
calcitriol
2007
Completed Phase 1
~90
PHNO
2017
Completed Phase 1
~30
Placebo oral capsule
2010
Completed Phase 4
~2380

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Center for Complementary and Integrative Health (NCCIH)NIH
830 Previous Clinical Trials
668,972 Total Patients Enrolled
4 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
227 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Brain & Behavior Research FoundationOTHER
61 Previous Clinical Trials
2,790 Total Patients Enrolled
Yale UniversityLead Sponsor
1,846 Previous Clinical Trials
2,736,455 Total Patients Enrolled
5 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
229 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum sample size for this research project?

"Yes, the information on clinicaltrials.gov indicates that this clinical trial is presently recruiting patients. The study was originally posted on 8/15/2017 and was most recently edited on 11/4/2022. The clinical trial is searching for 24 patients between 1 sites."

Answered by AI

Are people currently signing up for this research project?

"This is an ongoing clinical trial, as shown by the dates on clinicaltrials.gov; it was initially posted on 8/15/2017 and updated as recently as 11/4/2022."

Answered by AI

What are calcitriol's standard therapeutic benefits?

"Calcitriol is a versatile medication that can help patients manage disease symptoms as well as conditions like pain, ADHD, and narcolepsy."

Answered by AI

Does this trial have an age limit? If so, what is it?

"The age range for participants that this study is recruiting are individuals who are over 18 years old but not yet 50."

Answered by AI

Are there precedent studies that suggest calcitriol's efficacy?

"Currently, 12 research trials are underway to study the efficacy of calcitriol. 2 of thosePhase 3 trials are ongoing. Most of the research for this treatment is based in Lexington, Kentucky; however, there are 17 clinical sites total running these tests."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Other
New York
Connecticut
How old are they?
18 - 65
What site did they apply to?
Connecticut Mental Health Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+

Why did patients apply to this trial?

I have diagnosed anxiety as well as ADHD and my doctors haven’t been able to control both via medication. One always makes the other worse. I would love to find a solution so I can better perform in work and every day life.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What do the hours look like? Do I need to take off work? Will I be planning my own sleeping arrangements?
PatientReceived 1 prior treatment
~3 spots leftby Apr 2025