NCT03958474 is a EARLY_PHASE1 clinical trial of Oxycodone in Opioid Use Disorder, sponsored by Joshua A. Lile, Ph.D..

Who is sponsoring NCT03958474?

NCT03958474 is sponsored by Joshua A. Lile, Ph.D..

What drugs are being tested in NCT03958474?

Interventions in NCT03958474: Oxycodone, Remifentanil.

What condition does NCT03958474 study?

NCT03958474 studies Opioid Use Disorder.

Is NCT03958474 still recruiting?

NCT03958474 is currently completed. Last updated 24 October 2025.

Last reviewed 2025-10-24 · How we verify

NCT03958474

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

Neurobehavioral Mechanisms of Choice in Opioid Use Disorder

Completed EARLY_PHASE1 Last updated 24 October 2025

What this trial tests

EARLY_PHASE1 trial testing Oxycodone in Opioid Use Disorder in 12 participants. Completed in 10 July 2025.

Timeline

16 August 2019

Primary endpoint
10 July 2025

10 July 2025

Quick facts

Lead sponsor	Joshua A. Lile, Ph.D.
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	12
Start date	16 August 2019
Primary completion	10 July 2025
Estimated completion	10 July 2025
Sites	1 location across United States

Drugs / interventions tested

Oxycodone (oxycodone) — full drug profile →
Remifentanil — full drug profile →

Conditions studied

Opioid Use Disorder — all drugs for Opioid Use Disorder →

Sponsor

Joshua A. Lile, Ph.D. — full company profile →

Who can join

Adults 18 to 50, any sex, with Opioid Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this protocol is to use probabilistic reinforcement learning choice tasks and magnetic resonance neuroimaging to demonstrate the impact of problematic opioid use and opioid withdrawal on dynamic decision-making and reveal the neurobehavioral and neurobiological processes underlying abnormal task performance. A second objective is to identify an appropriate dose of intravenous remifentanil for subsequent studies in physically dependent individuals with opioid use disorder.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A dose-ranging study of the physiological and self-reported effects of repeated, rapid infusion of remifentanil in people with opioid use disorder and physical dependence on fentanyl.
Lile JA, Shellenberg TP, Babalonis S, Hatton KW, et al · · 2024 · cited 4× · PMID 38383903 · DOI 10.1007/s00213-024-06557-1

Verify or expand the search:

Other trials of Oxycodone

Trials testing the same drug.

NCT07153003 — Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And · Phase 4 · enrolling by invitation
NCT06757140 — Opioid Drug Interaction Study · Phase 1, PHASE2 · recruiting
NCT05965492 — Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery · Phase 3 · withdrawn
NCT06517069 — Effect of TEAS Combined With Oxycodone on Postoperative Visceral Pain in Gynecologic Laparoscopic Patients · NA · recruiting
NCT06340932 — Impact of Opioid Avoidance Protocol for ACL Reconstruction · completed

Other recruiting trials for Opioid Use Disorder

Currently open trials in the same condition.

NCT07278518 — Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine · NA · recruiting
NCT07044466 — Social Functioning in Opioid Use Disorder · NA · recruiting
NCT07158853 — Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder · NA · recruiting
NCT06943859 — Ketamine for Opioid Use Disorder · Phase 2 · recruiting
NCT06651177 — Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder · Phase 2 · recruiting

Other Joshua A. Lile, Ph.D. trials

Trials by the same sponsor.

NCT06137365 — Cannabis for Obesity Trial · Phase 2 · not yet recruiting
NCT06312657 — Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice · EARLY_PHASE1 · terminated
NCT04296006 — Neurobehavioral Mechanisms of Cocaine Choice · EARLY_PHASE1 · completed
NCT01511640 — Behavioral Effects of Pregabalin and Cannabis · EARLY_PHASE1 · completed
NCT02383043 — Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer · EARLY_PHASE1 · completed

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 NCT03958474 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Joshua A. Lile, Ph.D.
Last refreshed: 24 October 2025

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/NCT03958474.

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