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ClinicalTrials.gov public records Last synced Oct 24, 2026, 10:33 PM EDT

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Showing 1–24 of 84 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Extended-Release Naltrexone 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 28, 2021 · Synced Oct 24, 2026, 10:33 PM EDT
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 24, 2026, 10:33 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 24, 2026, 10:33 PM EDT
Recruiting No phase listed Observational Accepts healthy volunteers

Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment

NCT06104280
View directory record Official record
Conditions
Opioid Use Disorder, Sleep Disturbance
Interventions
Post-Illumination Pupillary Response (PIPR), Polysomnography, Multiple Sleep Latency Test, Ecological Momentary Assessments, Actigraphy, DLMO, Melatonin Suppression Test
Other · Behavioral · Device
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
18 Years to 80 Years
Enrollment
200 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2029
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Aug 11, 2026 · Synced Oct 24, 2026, 10:33 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 24, 2026, 10:33 PM EDT
Withdrawn Phase 4 Interventional

Efficacy of Naltrexone HCl/Bupropion HCl Extended Release Versus Placebo for Treatment of Weight Regain in Participants Post Bariatric Surgery

NCT02616315
View directory record Official record
Conditions
Weight Regain Post Bariatric Surgery
Interventions
Naltrexone HCl/Bupropion HCl Placebo, Naltrexone HCl/Bupropion HCl
Drug
Lead sponsor
Takeda
Industry
Eligibility
18 Years to 65 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
2
States / cities
Chicago, Illinois • Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Apr 8, 2016 · Synced Oct 24, 2026, 10:33 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 24, 2026, 10:33 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 24, 2026, 10:33 PM EDT
Completed Phase 3 Interventional Results available

Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain

NCT00415597
View directory record Official record
Conditions
Pain
Interventions
ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years to 70 Years
Enrollment
467 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2008
U.S. locations
58
States / cities
Birmingham, Alabama • Phoenix, Arizona • Tempe, Arizona + 48 more
Source: ClinicalTrials.gov public record
Updated Sep 20, 2013 · Synced Oct 24, 2026, 10:33 PM EDT
Completed Phase 4 Interventional Results available

Extended-release Naltrexone for Alcohol Dependence in Primary Care

NCT00620750
View directory record Official record
Conditions
Alcohol Dependence
Interventions
Extended release injectable naltrexone (Vivitrol)
Drug
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years and older
Enrollment
72 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Sep 27, 2011 · Synced Oct 24, 2026, 10:33 PM EDT
Completed Phase 4 Interventional Results available

Real World Effectiveness of Combining an Employer-based Weight Management Program With Medication for Chronic Weight Management in Employees With Obesity

NCT03799198
View directory record Official record
Conditions
Obesity
Interventions
Weight Management Program (WMP), Medication for chronic weight management (Rx)
Other · Drug
Lead sponsor
Novo Nordisk A/S
Industry
Eligibility
18 Years and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Nov 14, 2022 · Synced Oct 24, 2026, 10:33 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 24, 2026, 10:33 PM EDT
Completed Phase 2Phase 3 Interventional

EXHIT ENTRE Comparative Effectiveness Trial

NCT04345718
View directory record Official record
Conditions
Substance Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe
Interventions
Extended Release Buprenorphine, Treatment as Usual
Drug
Lead sponsor
Gavin Bart
Other
Eligibility
18 Years and older
Enrollment
344 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
6
States / cities
New Haven, Connecticut • Baltimore, Maryland • Boston, Massachusetts + 2 more
Source: ClinicalTrials.gov public record
Updated Dec 9, 2025 · Synced Oct 24, 2026, 10:33 PM EDT
Completed Not applicable Interventional Results available

Alcohol Pharmacotherapy for HIV+ Prisoners

NCT01077310
View directory record Official record
Conditions
Alcohol Dependence, Problem Drinking, Hazardous Drinking, Human Immunodeficiency Virus, AIDS
Interventions
Vivitrol- Intramuscular naltrexone (depot-formulation), Placebo
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2015
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated May 30, 2017 · Synced Oct 24, 2026, 10:33 PM EDT
Completed Not applicable Interventional Results available

Mindfulness-Based Relapse Prevention to Improve Medication Assisted Treatment Adherence and Drug-use Outcomes for Opioid Use Disorder

NCT05042388
View directory record Official record
Conditions
Opioid-use Disorder
Interventions
Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA), Treatment-As-Usual
Behavioral
Lead sponsor
West Chester University of Pennsylvania
Other
Eligibility
18 Years and older
Enrollment
105 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
1
States / cities
West Chester, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Mar 31, 2026 · Synced Oct 24, 2026, 10:33 PM EDT
Completed Phase 2Phase 3 Interventional Results available

Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up

NCT03275350
View directory record Official record
Conditions
Opioid-use Disorder, Hiv
Interventions
Naltrexone Injectable Suspension, Treatment as usual
Drug · Other
Lead sponsor
Oregon Health and Science University
Other
Eligibility
18 Years and older
Enrollment
114 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2019
U.S. locations
5
States / cities
Tarzana, California • Miami, Florida • Chicago, Illinois + 2 more
Source: ClinicalTrials.gov public record
Updated Apr 27, 2022 · Synced Oct 24, 2026, 10:33 PM EDT
Terminated Phase 2 Interventional Results available

Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1

NCT04480554
View directory record Official record
Conditions
Opioid-use Disorder, HIV-1-infection, Immune Activation, Inflammation, Methadone, Buprenorphine, Naltrexone, Antiretroviral Treatment
Interventions
Methadone, Buprenorphine/naloxone, XR-Naltrexone
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 65 Years
Enrollment
78 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Apr 7, 2026 · Synced Oct 24, 2026, 10:33 PM EDT
Completed Phase 4 Interventional Results available

Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care

NCT01893827
View directory record Official record
Conditions
Alcohol Dependence
Interventions
XR-NTX (Extended-Release Naltrexone), Oral Naltrexone (O-NTX)
Drug
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years and older
Enrollment
237 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2018
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jun 16, 2020 · Synced Oct 24, 2026, 10:33 PM EDT
Completed Not applicable Interventional

Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder

NCT05053503
View directory record Official record
Conditions
Opioid-use Disorder, Opioid Withdrawal
Interventions
Sparrow Ascent Therapy System, Lofexidine, Extended-release injectable naltrexone
Device · Drug
Lead sponsor
Spark Biomedical, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
108 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
4
States / cities
Rancho Mirage, California • Crownsville, Maryland • Center City, Minnesota + 1 more
Source: ClinicalTrials.gov public record
Updated Jul 4, 2025 · Synced Oct 24, 2026, 10:33 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder

NCT01982643
View directory record Official record
Conditions
Methamphetamine Use Disorder
Interventions
naltrexone plus bupropion
Drug
Lead sponsor
Walter Ling
Other
Eligibility
18 Years to 65 Years
Enrollment
49 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
3
States / cities
Los Angeles, California • Honolulu, Hawaii • Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Mar 23, 2020 · Synced Oct 24, 2026, 10:33 PM EDT
Terminated Phase 4 Interventional Results available

Emergency Department Initiated Extended-Release Naltrexone and Case Management for the Treatment of Alcohol Use Disorder

NCT04094584
View directory record Official record
Conditions
Alcohol Use Disorder, Substance Use, Alcohol Abuse or Dependence
Interventions
Vivitrol (Extended Release Naltrexone)
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
21 Years and older
Enrollment
179 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 Jun 22, 2023 · Synced Oct 24, 2026, 10:33 PM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Intervention to Expand Opioid Use Disorder Treatment Pharmacotherapy Prescribers

NCT02926482
View directory record Official record
Conditions
Opioid-use Disorder
Interventions
Prescriber Recruitment Bundle (PRB)
Behavioral
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
Not listed
Enrollment
76 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2019
U.S. locations
3
States / cities
Tallahassee, Florida • Columbus, Ohio • Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Aug 13, 2024 · Synced Oct 24, 2026, 10:33 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 24, 2026, 10:33 PM EDT
Terminated Phase 4 Interventional Results available

Naltrexone/Bupropion Cardiovascular Outcomes Study

NCT02638129
View directory record Official record
Conditions
Obesity, Cardiovascular Diseases
Interventions
Naltrexone HCl/Bupropion HCl ER, Placebo
Drug
Lead sponsor
Orexigen Therapeutics, Inc
Industry
Eligibility
18 Years and older
Enrollment
67 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016
U.S. locations
139
States / cities
Alexander City, Alabama • Auburn, Alabama • Birmingham, Alabama + 136 more
Source: ClinicalTrials.gov public record
Updated Feb 27, 2017 · Synced Oct 24, 2026, 10:33 PM EDT