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Showing 1–19 of 19 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Extended-release naltrexone injection, 380 mg Clear all
Completed Phase 2Phase 3 Interventional Accepts healthy volunteers Results available

Outcomes of Opioid Addicted Prisoners With Extended-Release Injectable Naltrexone

NCT02617628
View directory record Official record
Conditions
Opiate Dependence
Interventions
extended release naltrexone
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years and older
Enrollment
146 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2018
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jan 27, 2021 · Synced Sep 29, 2026, 4:49 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 15, 2020 · Synced Sep 29, 2026, 4:49 PM EDT
Completed Phase 4 Interventional Results available

Alcohol Disorder hOsPital Treatment Trial

NCT02478489
View directory record Official record
Conditions
Heavy Drinking, Alcohol Dependence, Alcohol Use Disorder
Interventions
Oral naltrexone (PO-NTX), Extended-release injectable naltrexone (XR-NTX)
Drug
Lead sponsor
Boston University
Other
Eligibility
18 Years and older
Enrollment
248 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2020
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jun 28, 2021 · Synced Sep 29, 2026, 4:49 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 12, 2016 · Synced Sep 29, 2026, 4:49 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 10, 2017 · Synced Sep 29, 2026, 4:49 PM EDT
Completed Phase 4 Interventional

Biomarkers of Injectable Extended Release Naltrexone Treatment

NCT02324725
View directory record Official record
Conditions
Heroin Dependence, Opioid Dependence
Interventions
Naltrexone
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 55 Years
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2021
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jan 11, 2023 · Synced Sep 29, 2026, 4:49 PM EDT
Completed Phase 3 Interventional Results available

Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study

NCT01908062
View directory record Official record
Conditions
Opioid Use Disorder, Alcohol Use Disorder
Interventions
Extended Release Naltrexone, Treatment As usual
Drug · Other
Lead sponsor
Oregon Health and Science University
Other
Eligibility
18 Years to 100 Years
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Mar 18, 2019 · Synced Sep 29, 2026, 4:49 PM EDT
Completed Phase 2 Interventional Results available

Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence

NCT01690546
View directory record Official record
Conditions
Opiate Dependence
Interventions
very low dose naltrexone, extended release naltrexone, buprenorphine/naloxone
Drug
Lead sponsor
Paolo Mannelli
Other
Eligibility
18 Years to 65 Years
Enrollment
38 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated May 31, 2016 · Synced Sep 29, 2026, 4:49 PM EDT
Completed Phase 2 Interventional Results available

VIVITROL as a Treatment for Cocaine and Alcohol Dependence

NCT00777062
View directory record Official record
Conditions
Cocaine Dependence, Alcohol Dependence
Interventions
VIVITROL (Naltrexone extended-release injectable suspension), Placebo
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 65 Years
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jan 25, 2018 · Synced Sep 29, 2026, 4:49 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 10, 2018 · Synced Sep 29, 2026, 4:49 PM EDT
Completed Phase 3 Interventional Results available

Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder

NCT03078075
View directory record Official record
Conditions
Methamphetamine Use Disorder
Interventions
Naltrexone: Vivitrol®, Placebo (PLB) Injectable, Bupropion: Wellbutrin XL®, Placebo (PLB) Oral
Drug
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years to 65 Years
Enrollment
403 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
8
States / cities
Los Angeles, California • San Francisco, California • Minneapolis, Minnesota + 5 more
Source: ClinicalTrials.gov public record
Updated May 2, 2021 · Synced Sep 29, 2026, 4:49 PM EDT
Terminated Phase 1 Interventional

Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia

NCT06374290
View directory record Official record
Conditions
Smoking Cessation
Interventions
Naltrexone (Vivitrol), Bupropion
Drug
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Eligibility
18 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 15, 2025 · Synced Sep 29, 2026, 4:49 PM EDT
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 Jul 29, 2026 · Synced Sep 29, 2026, 4:49 PM EDT
Completed Phase 2Phase 3 Interventional Accepts healthy volunteers Results available

Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site

NCT00781898
View directory record Official record
Conditions
Opiate Addiction
Interventions
Depot naltrexone, Treatment as Usual (TAU)
Drug · Other
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 60 Years
Enrollment
308 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008 – 2015
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 22, 2017 · Synced Sep 29, 2026, 4:49 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 13, 2025 · Synced Sep 29, 2026, 4:49 PM EDT
Completed Early Phase 1 Interventional Results available

Inpatient Single Dose Interventions for Alcohol Use Disorder

NCT04562779
View directory record Official record
Conditions
Alcohol Use Disorder, Severe
Interventions
Naltrexone 380 MG, Ketamine Hydrochloride, Enhanced linkage
Drug · Behavioral
Lead sponsor
Denver Health and Hospital Authority
Other
Eligibility
18 Years to 65 Years
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
1
States / cities
Denver, Colorado
Source: ClinicalTrials.gov public record
Updated May 1, 2024 · Synced Sep 29, 2026, 4:49 PM EDT
Recruiting Phase 4 Interventional

Naltrexone in AUD Reward Drinkers

NCT05028062
View directory record Official record
Conditions
Alcohol Use Disorder, Alcoholism
Interventions
XR-NTX 380 mg, intramuscular injection, Medical Management, Placebo intramuscular injection
Drug · Behavioral
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 65 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2028
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jan 19, 2026 · Synced Sep 29, 2026, 4:49 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 24, 2017 · Synced Sep 29, 2026, 4:49 PM EDT
Completed Phase 2 Interventional Results available

The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence

NCT01556425
View directory record Official record
Conditions
Opioid Dependence
Interventions
Vivitrol, Employment-based opiate abstinence reinforcement, Usual Care Control
Drug · Behavioral · Other
Lead sponsor
Johns Hopkins University
Other
Eligibility
18 Years to 65 Years
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2017
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Mar 11, 2018 · Synced Sep 29, 2026, 4:49 PM EDT