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NCT06261905 · ClinicalTrials.gov registry record · Phase 1
Vitamin D in OUD: Exploration of Alterations on the Dopamine D2/D3 Receptor System
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT06261905: Completed Phase 1 study, sponsored by Yale University.
NCT06261905 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06261905, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
BPND is a metric that assesses the level of dopamine activity in a priori regions of interest. For Specific Aim 1, the investigators plan to assess the differences in baseline BPND in dopamine D2/D3 receptors between healthy control subjects and the baseline placebo-controlled scan for subjects with OUD.
Interventions
- OTHER Placebo Control
- DIETARY_SUPPLEMENT Calcitriol
- PROCEDURE PET Scan
- DRUG [11C]-PHNO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2024-03-13 |
| Est. Completion | 2025-02-18 |
| Phase | Phase 1 |
What the finished NCT06261905 record still lists
NCT06261905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo Control is the first listed.
NCT06261905 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06261905 about?
NCT06261905 is a clinical study titled "Vitamin D in OUD: Exploration of Alterations on the Dopamine D2/D3 Receptor System". 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, ...
What is the current status of trial NCT06261905?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2024-03-13. Estimated completion is 2025-02-18.
What interventions are being tested in trial NCT06261905?
The interventions under investigation include: Placebo Control (OTHER), Calcitriol (DIETARY_SUPPLEMENT), PET Scan (PROCEDURE), [11C]-PHNO (DRUG).
Who is sponsoring clinical trial NCT06261905?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06261905's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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