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Vitamin d brain scans aim to uncover opioid disorder clues

NCT ID NCT06261905

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 study at Yale University looked at how vitamin D (calcitriol) affects dopamine receptors in the brains of people with opioid use disorder. Five participants received either vitamin D or a placebo and had PET scans to measure brain activity. The goal was to understand the brain's dopamine system better, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Calcitriol (active form of vitamin D)
What this could lead to
If successful, this could point toward vitamin D as a potential add-on treatment to help manage opioid use disorder.
What could go wrong
This is a very small early-phase study with only 5 participants, so results may not apply broadly. It is designed to measure brain activity, not to test treatment effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

5 people

The number who actually took part.

Started

Mar 2024

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-50 years 2. Voluntary, written, informed consent 3. Physically healthy by medical history, physical, neurological, ECG, and laboratory examinations 4. Meets the criteria for OUD, as determined by the Structured Clinical Interview for DSM-5 (SCID) 5. Stable and receiving buprenorphine treatment for OUD 6. For females, non-lactating, with a negative serum or urine pregnancy (hCG) test 7. Lab results without clinically relevant findings (e.g., renal function, electrolytes, and vitamin D levels) 8. English speaking Exclusion criteria: 1. Medical contraindication to calcitriol administration (e.g., history of hypersensitivity to calcitriol or any component of the formulation, hypercalcemia or vitamin D toxicity) 2. History of substance dependence (e.g., alcohol, sedative hypnotics), except for nicotine and opiates. 3. A primary major DSM-5 psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, etc.) as determined by the SCID, except for Opioid Use Disorder and related conditions. 4. A history of significant medical (e.g., cardiovascular, diabetic/metabolic) or neurological (e.g., cerebrovascular accidents, seizure, traumatic brain injury) illness 5. Positive answers on the cardiac history questionnaire that may place the subject at higher risk, as determined by the study physician's review of both the questionnaire responses and screening ECG. If there is concern for the subject's safety due to these assessments, research staff will consult a Yale PET Center affiliated cardiologist prior to including the subject for the study. 6. Current use of psychotropic and/or potentially psychoactive prescription medications 7. Receiving medications for OUD other than buprenorphine (e.g., methadone treatment) 8. 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) 10. History of claustrophobia or feeling of inability to lie still on his/her back for the PET or MRI scans 11. History of any bleeding disorder or current anticoagulant therapy 12. 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. 13. 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 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,). 14. Serum levels of 25(OH)D3 below 12 ng/ml. 15. Morbid obesity i.e., BMI over 35 (more prone to lower vitamin D levels) 16. Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year. 17. Subjects with current, past or anticipated exposure to radiation in the workplace 18. History of kidney stones within the past 5 years 19. Any degree of renal failure 20. History of parathyroid disorder (hyper or hypoparathyroidism) 21. History of osteoporosis or any pathologic fractures 22. Vitamin D supplementation in any form in the past 3 months 23. Known hypersensitivity to \[11C\]-PHNO or calcitriol 24. Malabsorption syndromes (i.e., Celiac sprue) 25. Serum corrected calcium \> 10.5 mg/dl or phosphate \> 4.2 mg/dL

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Yale School of Medicine

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.