NCT03386591 is a Phase 1 clinical trial of Naloxone in Opioid-use Disorder, sponsored by National Institute on Drug Abuse (NIDA).

Who is sponsoring NCT03386591?

NCT03386591 is sponsored by National Institute on Drug Abuse (NIDA).

What drugs are being tested in NCT03386591?

Interventions in NCT03386591: Naloxone, Mucosal atomization device and syringe, Narcan, Intramuscular Auto Injector.

What condition does NCT03386591 study?

NCT03386591 studies Opioid-use Disorder.

Is NCT03386591 still recruiting?

NCT03386591 is currently completed. Last updated 9 March 2018.

Last reviewed 2018-03-09 · How we verify

NCT03386591

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

Comparison of Naloxone Pharmacokinetics

Completed Phase 1 Last updated 9 March 2018

What this trial tests

Phase 1 trial testing Naloxone in Opioid-use Disorder in 30 participants. Completed in 6 March 2018.

Timeline

3 January 2018

Primary endpoint
8 February 2018

6 March 2018

Quick facts

Lead sponsor	National Institute on Drug Abuse (NIDA)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	3 January 2018
Primary completion	8 February 2018
Estimated completion	6 March 2018
Sites	1 location across United States

Drugs / interventions tested

Naloxone (NALOXONE) — full drug profile →
Mucosal atomization device and syringe
Narcan (NALOXONE) — full drug profile →
Intramuscular Auto Injector

Conditions studied

Opioid-use Disorder — all drugs for Opioid-use Disorder →

Sponsor

National Institute on Drug Abuse (NIDA)

Who can join

Adults 18 to 55, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Intranasal (IN) naloxone administration is an effective alternative to intravenous (IV) or intramuscular (IM) naloxone by emergency medical services for opioid overdoses and has been used successfully for this purpose as reported in clinical observational studies and a randomized controlled trial. Most of the published clinical studies concerning IN administration used an improvised kit of 2 mg naloxone/2 mL saline and a mucosal atomizer device (MAD), which is not FDA-approved for this indication. Pharmacokinetic (PK) data using these kits is not available in the published literature. This study is designed to determine the PK of naloxone following one and two IN administrations using the improvised kits compared to 2 and 4 mg delivered IN using the FDA-approved Narcan nasal spray device and 2 mg administered IM using the Evzio autoinjector.

Publications & conference data

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

Comparison of the Pharmacokinetic Properties of Naloxone Following the Use of FDA-Approved Intranasal and Intramuscular Devices Versus a Common Improvised Nasal Naloxone Device.
Krieter PA, Chiang CN, Gyaw S, McCann DJ. · · 2019 · cited 25× · PMID 30861160 · DOI 10.1002/jcph.1401

Verify or expand the search:

Other trials of Naloxone

Trials testing the same drug.

NCT04975334 — Opioid Antagonism in Hypogonadotropic Hypogonadism · Phase 1 · completed
NCT05886712 — Improving Access to Naloxone to Prevent Opioid Overdose Deaths (SAIA-Naloxone) · NA · active not recruiting
NCT05490134 — RM1 Project 1 - tAN Naloxone · EARLY_PHASE1 · recruiting
NCT04975347 — Opioid Antagonism in Individuals Ascertained Through the Partners HealthCare Biobank · Phase 1 · completed
NCT05360030 — Mechanism of Analgesic Effect on Prolonged Continuous Theta Burst Stimulation · NA · completed

Other recruiting trials for Opioid-use Disorder

Currently open trials in the same condition.

NCT04783558 — Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk · NA · active not recruiting
NCT05011266 — Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder · Phase 2, PHASE3 · recruiting
NCT05039554 — Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment · NA · recruiting
NCT05033028 — Smartphones for Opiate Addiction Recovery · Phase 3 · recruiting
NCT04738825 — Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With Pr · NA · recruiting

Other National Institute on Drug Abuse (NIDA) trials

Trials by the same sponsor.

NCT07468552 — Trial of Tirzepatide for the Treatment of Cannabis Use Disorder · Phase 2 · not yet recruiting
NCT06808932 — VK4-116 Phase I Study With Food-Effect · Phase 1 · not yet recruiting
NCT06676059 — SMART-r: Substance Monitoring and Active Relapse Tracking Repository · recruiting
NCT06577454 — Measuring the Effects of Neurostimulation on Risky and Ambiguous Decision-Making Capacity in People With and Without Sub · NA · suspended
NCT06868914 — Phase I Trial of High-Density Theta Burst Stimulation (hdTBS) · Phase 1 · not yet recruiting

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 NCT03386591 (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 National Institute on Drug Abuse (NIDA)
Last refreshed: 9 March 2018

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/NCT03386591.

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