Who is sponsoring NCT03612713?

NCT03612713 is sponsored by Yale University.

What drugs are being tested in NCT03612713?

Interventions in NCT03612713: Oxycodone Medication First, Placebo First.

What condition does NCT03612713 study?

NCT03612713 studies Prescription Drug Abuse (Not Dependent).

Is NCT03612713 still recruiting?

NCT03612713 is currently completed. Last updated 8 March 2024.

Are results published for NCT03612713?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-03-08 · How we verify

NCT03612713

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Influence of Medication on Functional Connectivity

Completed EARLY_PHASE1 Results posted Last updated 8 March 2024

What this trial tests

EARLY_PHASE1 trial testing Oxycodone Medication First in Prescription Drug Abuse (Not Dependent) in 20 participants. Completed in 2 June 2022.

Timeline

30 October 2018

Primary endpoint
2 June 2022

2 June 2022

Quick facts

Lead sponsor	Yale University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	basic science
Enrollment	20
Start date	30 October 2018
Primary completion	2 June 2022
Estimated completion	2 June 2022
Sites	1 location across United States

Drugs / interventions tested

Oxycodone Medication First — full drug profile →
Placebo First — full drug profile →

Conditions studied

Prescription Drug Abuse (Not Dependent) — all drugs for Prescription Drug Abuse (Not Dependent) →

Sponsor

Yale University

Who can join

Adults 18 to 30, any sex, with Prescription Drug Abuse (Not Dependent). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Functional Connectivity Following Oxycodone Administration Primary · Change in functional connectivity from initial fMRI scan to follow-up MRI scan, up to 4 weeks.

Functional connectivity is measured by functional magnetic resonance imagery (fMRI). Change in functional connectivity (a statistical relationship between two regions in the brain) between placebo and oxycodone fMRI scans will be assessed. Result is a transformed z-score. A score of 0 indicates no change. Higher scores indicate increased connectivity.

Positive network strength for connectivity within the ventral attention network

Group	Value	95% CI
Oxycodone Run	2.66	± 1.37
Placebo Run	4.55	± 2.46

Negative network strength for connectivity within the ventral attention network

Group	Value	95% CI
Oxycodone Run	.99	± .88
Placebo Run	1.60	± .54

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 4 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oxycodone Medication

Serious: 0/20 (0%)

Deaths: 0/20

Placebo

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (1 terms — click to expand)

Reaction	System	Oxycodone Medication	Placebo
Nausea and vomiting	General disorders	—	—

Data from ClinicalTrials.gov NCT03612713 adverse events section.

Sponsor's own description

This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03612713 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 8 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03612713.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing