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ClinicalTrials.gov public records Last synced Oct 23, 2026, 10:10 PM EDT

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Showing 1–24 of 35 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Intramuscular Naloxone Clear all
Active, not recruiting Phase 1 Interventional Accepts healthy volunteers

iSTEP-N 101b: Pharmacokinetics and Safety Study of Low- and High-Dose Naltrexone Implants vs Monthly Vivitrol in Healthy Volunteers

NCT07064564
View directory record Official record
Conditions
Opioid Use Disorder
Interventions
Naltrexone implant, 14.4 grams, Naltrexone implant, 9.6 grams, Extended-release naltrexone injection, 380 mg
Drug
Lead sponsor
Akyso Therapeutics, LLC
Industry
Eligibility
18 Years to 65 Years
Enrollment
33 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2029
U.S. locations
1
States / cities
Millcreek, Utah
Source: ClinicalTrials.gov public record
Updated Sep 30, 2026 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 4 Interventional Results available

ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults

NCT00511836
View directory record Official record
Conditions
Alcohol Dependence
Interventions
VIVITROL 380 mg, Placebo
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
31 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
1
States / cities
Belmont, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 11, 2017 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 3 Interventional Results available

Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone

NCT00577408
View directory record Official record
Conditions
Opiate Dependence, Heroin Dependence
Interventions
depot naltrexone, Oral Naltrexone
Drug
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 60 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2011
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Aug 25, 2017 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscular Injection (IM) in Healthy Volunteers

NCT03827642
View directory record Official record
Conditions
Healthy Volunteer
Interventions
Treatment A: Naloxone Nasal Spray, Treatment B: Naloxone Nasal Spray, Treatment C: Naloxone HCl Intravenous (IV) Injection, Treatment D: Naloxone HCl Intramuscular (IM) Injection
Drug
Lead sponsor
INSYS Therapeutics Inc
Industry
Eligibility
18 Years to 45 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Feb 1, 2019 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 4 Interventional Results available

Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings

NCT02978417
View directory record Official record
Conditions
Opioid-Related Disorders
Interventions
Naltrexone for extended-release injectable suspension, Oral naltrexone
Drug
Lead sponsor
Duke University
Other
Eligibility
18 Years to 65 Years
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
1
States / cities
Raleigh, North Carolina
Source: ClinicalTrials.gov public record
Updated Jun 16, 2020 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 2 Interventional

Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM)

NCT01449565
View directory record Official record
Conditions
Amphetamine-Related Disorders
Interventions
Naltrexone, Placebo
Drug
Lead sponsor
San Francisco Department of Public Health
Government
Eligibility
18 Years to 65 Years · Male only
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Apr 13, 2016 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 2 Interventional Results available

Multiple Dose Study of Blockade of Opioid Effects by Injections of Buprenorphine in Participants With Opioid Disorder

NCT02044094
View directory record Official record
Conditions
Opioid Use Disorder
Interventions
Buprenorphine, buprenorphine and naloxone, hydromorphone, placebo
Drug
Lead sponsor
Indivior Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
39 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Apr 24, 2018 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 3 Interventional Results available

ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals

NCT00834080
View directory record Official record
Conditions
Opiate Dependence
Interventions
Medisorb naltrexone 380 mg
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years and older
Enrollment
38 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2012
U.S. locations
11
States / cities
Colton, California • Oceanside, California • Lauderhill, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Dec 11, 2018 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Pharmacokinetic Study of Vivitrol in Healthy Participants

NCT04716881
View directory record Official record
Conditions
Opioid-use Disorder
Interventions
Naltrexone 380 MG
Drug
Lead sponsor
Go Medical Industries Pty Ltd
Industry
Eligibility
18 Years to 57 Years
Enrollment
9 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2022
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Feb 23, 2024 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Proof of Concept (PoC) Evaluation of Naloxone Unique Intramuscular (IM) Injection

NCT07180420
View directory record Official record
Conditions
Healthy Volunteer - Complete
Interventions
naloxone IM
Drug
Lead sponsor
STAT Therapeutics Inc
Industry
Eligibility
18 Years to 55 Years
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024
U.S. locations
1
States / cities
Lenexa, Kansas
Source: ClinicalTrials.gov public record
Updated Sep 18, 2025 · Synced Oct 23, 2026, 10:10 PM EDT
Not listed Phase 4 Interventional

Nasal Naloxone for Narcotic Overdose

NCT01912573
View directory record Official record
Conditions
Drug Overdose
Interventions
Intranasal (IN) naloxone, Intravenous (IV) naloxone, Intramuscular (IM) naloxone, Intraosseus (IO) naloxone
Drug
Lead sponsor
Judith Feinberg
Other
Eligibility
12 Years and older
Enrollment
236 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
3
States / cities
Batavia, Ohio • Portsmouth, Ohio • West Union, Ohio
Source: ClinicalTrials.gov public record
Updated Jul 31, 2013 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers

NCT02750748
View directory record Official record
Conditions
Opioid-Related Disorders
Interventions
Naltrexone, Intravail
Drug · Other
Lead sponsor
National Institute on Drug Abuse (NIDA)
NIH
Eligibility
18 Years to 55 Years
Enrollment
14 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Jan 12, 2017 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 4 Interventional

Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults

NCT04219540
View directory record Official record
Conditions
Opioid-use Disorder
Interventions
XR-B (SUBLOCADETM), XR-NTX
Drug
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years and older
Enrollment
675 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
6
States / cities
New Haven, Connecticut • Baltimore, Maryland • Hanover, New Hampshire + 3 more
Source: ClinicalTrials.gov public record
Updated May 14, 2025 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 4 Interventional

Pre-Release VIVITROL for Opioid Dependent Inmates

NCT01563718
View directory record Official record
Conditions
Substance-Related Disorders
Interventions
naltrexone for extended release injectable suspension
Drug
Lead sponsor
Rhode Island Hospital
Other
Eligibility
18 Years to 60 Years
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Oct 22, 2015 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 3 Interventional Results available

Oral vs. Injectable Naltrexone for Hospitalized Veterans With Alcohol Dependence

NCT01856712
View directory record Official record
Conditions
Alcohol Dependence
Interventions
Naltrexone
Drug
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
18 Years and older
Enrollment
54 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Mar 5, 2019 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting Conditions

NCT02138396
View directory record Official record
Conditions
Bioavailability
Interventions
Fentanyl Sublingual Spray (FSS), Fentanyl Citrate Injection (FCI), Naltrexone
Drug
Lead sponsor
INSYS Therapeutics Inc
Industry
Eligibility
18 Years to 55 Years
Enrollment
12 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Dec 12, 2014 · Synced Oct 23, 2026, 10:10 PM EDT
Terminated Phase 1 Interventional Results available

The Effect of Chronic Pain on Delay Discounting in Methadone Patients

NCT04473950
View directory record Official record
Conditions
Opioid-use Disorder, Chronic Pain Syndrome
Interventions
Naloxone Hydrochloride, Placebo
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years to 65 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Mar 26, 2025 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 2Phase 3 Interventional Results available

Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

NCT01227044
View directory record Official record
Conditions
Reduction in Heavy Drinking in Patients With HIV
Interventions
Naltrexone, Placebo + Medication Management/Medication Coaching
Drug · Other
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2017
U.S. locations
2
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Mar 21, 2019 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Not applicable Interventional Accepts healthy volunteers

A Usability Assessment of Naloxone Administration by Untrained Community Members

NCT04025671
View directory record Official record
Conditions
Harm Reduction, Opioid-use Disorder, Naloxone
Interventions
Nasal Spray Naloxone, Intramuscular Naloxone, Improvised Nasal Atomizer
Device
Lead sponsor
State University of New York - Upstate Medical University
Other
Eligibility
18 Years and older
Enrollment
208 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017
U.S. locations
1
States / cities
Syracuse, New York
Source: ClinicalTrials.gov public record
Updated Jul 19, 2019 · Synced Oct 23, 2026, 10:10 PM EDT
Recruiting Phase 2Phase 3 Interventional Accepts healthy volunteers

Naltrexone for Overdose Prevention

NCT06633900
View directory record Official record
Conditions
Overdose Accidental
Interventions
IM naltrexone, Usual Care
Drug · Behavioral
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years and older
Enrollment
100 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2027
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Jun 9, 2026 · Synced Oct 23, 2026, 10:10 PM EDT
Not yet recruiting Phase 1Phase 2 Interventional

Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder

NCT07871877
View directory record Official record
Conditions
Opioid Use Disorder, Opioid Withdrawal, Substance Use Disorders
Interventions
Ibogaine Hydrochloride, Extended-release naltrexone injection, 380 mg, Matching Oral Placebo, Matching Intramuscular Placebo, My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform, Standardized Psychological Preparation, Integration and Recovery Support, Garmin-Enabled Longitudinal Wellness Monitoring
Drug · Device · Behavioral + 1 more
Lead sponsor
Clive Michelsen
Industry
Eligibility
18 Years to 65 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2027 – 2029
U.S. locations
1
States / cities
Basalt, Colorado
Source: ClinicalTrials.gov public record
Updated Oct 13, 2026 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg

NCT06719986
View directory record Official record
Conditions
Opioid Overdose
Interventions
Nalmefene HCl injection, Naloxone HCl intranasal
Drug
Lead sponsor
Purdue Pharma LP
Industry
Eligibility
18 Years to 55 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Jul 3, 2025 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) in Healthy Volunteers

NCT03827629
View directory record Official record
Conditions
Healthy Volunteer
Interventions
Treatment A: Naloxone Nasal Spray, Treatment B: Naloxone Nasal Spray, Treatment C: Naloxone HCL Intramuscular (IM) Injection
Drug
Lead sponsor
INSYS Therapeutics Inc
Industry
Eligibility
18 Years to 45 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Feb 1, 2019 · Synced Oct 23, 2026, 10:10 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Bioavailability Study of Naloxone 5 Milligrams (mg) Intramuscular (IM) Autoinjector

NCT05264493
View directory record Official record
Conditions
Healthy Volunteers
Interventions
NaxRedy ™, Naloxone Hydrochloride Injection, USP
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years to 55 Years
Enrollment
13 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Mar 3, 2022 · Synced Oct 23, 2026, 10:10 PM EDT