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Vitamin D in OUD: Exploration of Alterations on the Dopamine D2/D3 Receptor System

NCT06261905 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-11-14

No results posted yet for this 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.

Conditions

Interventions

DRUG

[11C]-PHNO

PHNO is used as a tracer for in-vivo imaging.

DIETARY_SUPPLEMENT

Calcitriol

Calcitriol is an active form of Vitamin D and is given in 3 0.5mcg capsules per dose.

OTHER

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.

PROCEDURE

PET Scan

A high resolution PET Scan performed using a NeurExplorer CT scanner.

Sponsors & Collaborators

Principal Investigators

  • Marc Potenza, MD, PhD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-13
Primary Completion
2025-02-18
Completion
2025-02-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06261905 on ClinicalTrials.gov