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Calcitriol for Opioid Use Disorder

Phase 1

Recruiting

Led By Marc Potenza, MD, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-50 years

Physically healthy by medical history, physical, neurological, ECG, and laboratory examinations

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two 120-minute scans, at least 6 days apart between study conditions.

Awards & highlights

Study Summary

"This trial is looking at how a vitamin D supplement, calcitriol, can help treat Opioid Use Disorder. They will compare brain scans of 12 people with OUD and 12

Who is the study for?

This trial is for adults with Opioid Use Disorder (OUD) and healthy individuals. Participants must be willing to undergo PET scans. Specific criteria for inclusion or exclusion are not detailed, but typically involve factors like age, health status, and the severity of OUD.Check my eligibility

What is being tested?

The study is testing whether calcitriol can affect dopamine receptors in people with OUD compared to healthy controls. It involves a double-blind setup where neither participants nor researchers know who's getting calcitriol or placebo during two PET scan sessions using [11C]-PHNO.See study design

What are the potential side effects?

Potential side effects are not listed, but common ones from similar studies may include discomfort at the injection site from the PET scan tracer and possible reactions to calcitriol such as high blood calcium levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 50 years old.

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I am physically healthy based on recent medical exams.

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I am on a stable dose of buprenorphine for opioid use disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two 120-minute scans, at least 6 days apart between study conditions.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two 120-minute scans, at least 6 days apart between study conditions.

This trial's timeline: 3 weeks for screening, Varies for treatment, and two 120-minute scans, at least 6 days apart between study conditions. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Non-displaceable Tracer Binding Potentials (BPND)

Secondary outcome measures

Continuous Performance Task - Identical Pairs (CPT-IP)

Probabilistic Reversal Learning Task (PRLT)

Spontaneous Blink Rate (SBR)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: CalcitriolActive Control3 Interventions

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.

Group II: PlaceboPlacebo Group3 Interventions

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.

0 / 3Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of PennsylvaniaOTHER

2,009 Previous Clinical Trials

42,894,629 Total Patients Enrolled

Yale UniversityLead Sponsor

1,854 Previous Clinical Trials

2,740,537 Total Patients Enrolled

Marc Potenza, MD, PhDPrincipal InvestigatorYale University

2 Previous Clinical Trials

4 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the criteria for eligibility to participate in this research endeavor?

"Individuals aged between 18 and 50 with a diagnosed opioid use disorder are eligible to participate in this trial, which aims to recruit approximately 24 suitable candidates."

Answered by AI

Are participants older than 25 years considered for this trial?

"Individuals between the ages of 18 and 50 are eligible to participate in this study according to the specified age parameters."

Answered by AI

What is the level of safety associated with Calcitriol usage in individuals?

"Given that this trial is in Phase 1 with limited safety and efficacy data, Calcitriol has been assigned a safety rating of 1 on the Power team's scale from 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Vitamin D in OUD: Exploration of Alterations on the Dopamine D2/D3 Receptor System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06261905.