Vitamin D in OUD: Exploration of Alterations on the Dopamine D2/D3 Receptor System (NCT06261905) | Clinical Trial Compass
CompletedPhase 1
Vitamin D in OUD: Exploration of Alterations on the Dopamine D2/D3 Receptor System
United States5 participantsStarted 2024-03-13
Plain-language summary
The research team is investigating Opioid Use Disorder (OUD), a disorder characterized by dysregulated dopaminergic tone, to evaluate the mechanisms of adjunctive treatment with calcitriol. The investigators will recruit 12 subjects with OUD and 12 healthy subjects to participate in a double-blind, randomized study design where subjects will complete up to 2 Positron Emission Tomography (PET) scans using \[11C\]-PHNO. The investigators will compare subjects in differences between their own study days and in differences between healthy control subjects and subjects with OUD.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18-50 years
. Voluntary, written, informed consent
. Physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
. Meets the criteria for OUD, as determined by the Structured Clinical Interview for DSM-5 (SCID)
. Stable and receiving buprenorphine treatment for OUD
. For females, non-lactating, with a negative serum or urine pregnancy (hCG) test
. Lab results without clinically relevant findings (e.g., renal function, electrolytes, and vitamin D levels)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Non-displaceable Tracer Binding Potentials (BPND)
Timeframe: One 120-minute scan.
2
Non-displaceable Tracer Binding Potentials (BPND)
Timeframe: Two 120-minute scans, at least 6 days apart between study conditions.
. 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, sedative hypnotics), except for nicotine and opiates.
. 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.
. 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 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.
. Current use of psychotropic and/or potentially psychoactive prescription medications
. Receiving medications for OUD other than buprenorphine (e.g., methadone treatment)
. For females, laboratory (β-HCG) or physical evidence of pregnancy/lactation