Vitamin D in OUD: Exploration of Alterations on the Dopamine D2/D3 Receptor System
NCT ID: NCT06261905
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
5 participants
INTERVENTIONAL
2024-03-13
2025-02-18
Brief Summary
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Detailed Description
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Research has indicated that a common feature in substance use disorders (SUD) is a hypo-dopaminergic state. Further, preclinical and observational research has pointed to a possible benefit of calcitriol in individuals who have OUD and our research group has previously shown the potential benefits of calcitriol on addressing this hypo-dopaminergic state. If successful, the results of this research study may improve the standard treatment for OUD through calcitriol supplementation.
Specifically, the present study seeks to address the following aims:
Specific Aim 1: As part of a between-subject study design, to determine whether acute calcitriol (vs. placebo) administration is associated with greater dopamine (DA) release in the caudate, putamen, ventral striatum (VST), and substantia nigra / ventral tegmental area (SN/VTA) of subjects with OUD compared to healthy control subjects (HCs).
Specific Aim 2: As part of a within-subject, two-day study design, to determine whether acute calcitriol (vs. placebo) administration is associated with greater dopamine (DA) release in the caudate, putamen, ventral striatum (VST), and substantia nigra / ventral tegmental area (SN/VTA) of subjects with OUD.
Specific Aim 3: To determine whether acute calcitriol (vs. placebo) administration is associated with higher spontaneous eyeblink rate, a non-PET indicator of higher dopamine activity, among subjects with OUD.
Specific Aim 4: To determine whether acute calcitriol (vs. placebo) administration is associated with better performance on neurocognitive measures (e.g., the Continuous Performance Task or CPT-IP and the Probabilistic Reversal Learning Task or PRLT) among subjects with OUD.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Calcitriol
Subjects with OUD will receive a baseline MRI. On the night before and day of testing, subjects with OUD will receive two doses of calcitriol (3.0mcg total), followed by PHNO injection and PET Scan for the calcitriol condition. All subjects will complete the study with both active calcitriol and a placebo control and the order these interventions are received will be randomized.
[11C]-PHNO
PHNO is used as a tracer for in-vivo imaging.
Calcitriol
Calcitriol is an active form of Vitamin D and is given in 3 0.5mcg capsules per dose.
PET Scan
A high resolution PET Scan performed using a NeurExplorer CT scanner.
Placebo
Subjects with OUD will receive a baseline MRI. On the night before and day of testing, subjects with OUD will receive two doses of an inactive placebo, followed by PHNO injection and PET Scan for the placebo condition. All subjects will complete the study with both active calcitriol and a placebo control and the order these interventions are received will be randomized.
[11C]-PHNO
PHNO is used as a tracer for in-vivo imaging.
Placebo Control
A placebo is an inert capsule, which contains no active ingredients. The placebo will be given in 3 0.5mcg capsules per dose.
PET Scan
A high resolution PET Scan performed using a NeurExplorer CT scanner.
Interventions
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[11C]-PHNO
PHNO is used as a tracer for in-vivo imaging.
Calcitriol
Calcitriol is an active form of Vitamin D and is given in 3 0.5mcg capsules per dose.
Placebo Control
A placebo is an inert capsule, which contains no active ingredients. The placebo will be given in 3 0.5mcg capsules per dose.
PET Scan
A high resolution PET Scan performed using a NeurExplorer CT scanner.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
50 Years
ALL
Yes
Sponsors
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University of Pennsylvania
OTHER
Yale University
OTHER
Responsible Party
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Principal Investigators
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Marc Potenza, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale School of Medicine
New Haven, Connecticut, United States
Countries
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Other Identifiers
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000
Identifier Type: OTHER
Identifier Source: secondary_id
2000036908
Identifier Type: -
Identifier Source: org_study_id