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ClinicalTrials.gov public records Last synced Oct 4, 2026, 8:07 AM EDT

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Showing 25–48 of 193 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Placebo (Naltrexone) Clear all
Completed Phase 3 Interventional Results available

Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)

NCT02537574
View directory record Official record
Conditions
Opioid Use Disorder
Interventions
NTX/BUP, NTX/PBO-B, PBO-N/PBO-B
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 60 Years
Enrollment
380 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
20
States / cities
Oceanside, California • Orange, California • Lauderhill, Florida + 17 more
Source: ClinicalTrials.gov public record
Updated Mar 6, 2019 · Synced Oct 4, 2026, 8:07 AM EDT
Not listed Phase 1 Interventional

Single-Blind Study of STAT-205 in Mild COVID-19

NCT04708327
View directory record Official record
Conditions
COVID-19
Interventions
STAT-205
Drug
Lead sponsor
Cytocom, Inc.
Industry
Eligibility
18 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
2
States / cities
Loma Linda, California • Pompano Beach, Florida
Source: ClinicalTrials.gov public record
Updated Dec 22, 2021 · Synced Oct 4, 2026, 8:07 AM EDT
Withdrawn Phase 2 Interventional

Naltrexone in the Treatment of Pyromania

NCT00467454
View directory record Official record
Conditions
Pyromania
Interventions
Naltrexone, Placebo
Drug
Lead sponsor
University of Minnesota
Other
Eligibility
16 Years to 75 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Dec 14, 2011 · Synced Oct 4, 2026, 8:07 AM EDT
Completed Phase 1Phase 2 Interventional Accepts healthy volunteers Results available

Opioid Modulation and Neural Reward Activation in Healthy Adults

NCT04854551
View directory record Official record
Conditions
Alcohol Drinking, Opioid Use, Unspecified
Interventions
Naltrexone, Placebo
Drug · Other
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years to 35 Years
Enrollment
13 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2022
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Nov 28, 2023 · Synced Oct 4, 2026, 8:07 AM EDT
Terminated Phase 4 Interventional Accepts healthy volunteers Results available

IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone

NCT04313972
View directory record Official record
Conditions
Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome, Low Dose Naltrexone, Low-dose Naltrexone, Naltrexone
Interventions
low-dose naltrexone, Placebo oral tablet
Drug
Lead sponsor
Endeavor Health
Other
Eligibility
18 Years to 110 Years · Female only
Enrollment
3 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021 – 2023
U.S. locations
1
States / cities
Skokie, Illinois
Source: ClinicalTrials.gov public record
Updated Mar 7, 2025 · Synced Oct 4, 2026, 8:07 AM EDT
Completed Phase 3 Interventional Results available

Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL

NCT02696434
View directory record Official record
Conditions
Opioid Use Disorder
Interventions
Naltrexone, Placebo, Buprenorphine
Drug
Lead sponsor
Alkermes, Inc.
Industry
Eligibility
18 Years to 60 Years
Enrollment
101 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
9
States / cities
Lauderhill, Florida • Oakland Park, Florida • Winfield, Illinois + 6 more
Source: ClinicalTrials.gov public record
Updated Feb 12, 2019 · Synced Oct 4, 2026, 8:07 AM EDT
Completed Phase 2 Interventional Results available

Targeted Interventions for Weight-Concerned Smokers

NCT00105482
View directory record Official record
Conditions
Nicotine Dependence
Interventions
Naltrexone, Transdermal nicotine replacement, Behavioral counseling
Drug · Behavioral
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
172 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2009
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Mar 5, 2013 · Synced Oct 4, 2026, 8:07 AM 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 4, 2026, 8:07 AM EDT
Withdrawn Phase 2 Interventional

Single-Site Study of Naltrexone/Acetaminophen for the Acute Treatment of Migraine: A Phase 2 Randomized Trial

NCT05685225
View directory record Official record
Conditions
Migraine
Interventions
Stage 1: Naltrexone/Acetaminophen, Stage 1: Naltrexone, Stage 1: Acetaminophen, Stage1: Placebo, Stage 2: Naltrxone/Acetaminophen high dose, Stage 2: Naltrexone/Acetaminophen medium dose, Stage 2: Naltrxone/Acetaminophen low dose, Stage 2: Placebo
Drug
Lead sponsor
Allodynic Therapeutics, Inc
Industry
Eligibility
18 Years to 75 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025
U.S. locations
1
States / cities
North Miami, Florida
Source: ClinicalTrials.gov public record
Updated Dec 8, 2025 · Synced Oct 4, 2026, 8:07 AM EDT
Withdrawn Phase 4 Interventional

Evaluation of Naltrexone as a Treatment for Self-injurious Behavior

NCT02726035
View directory record Official record
Conditions
Self-injurious Behavior, Self Mutilation
Interventions
Naltrexone, Placebo
Drug · Other
Lead sponsor
Western Michigan University School of Medicine
Other
Eligibility
13 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
1
States / cities
Kalamazoo, Michigan
Source: ClinicalTrials.gov public record
Updated Nov 6, 2017 · Synced Oct 4, 2026, 8:07 AM EDT
Completed Phase 1 Interventional

Augmenting Zyprexa With Naltrexone to Ameliorate Metabolic Side-Effects

NCT00567034
View directory record Official record
Conditions
Schizophrenia, Psychotic Disorders
Interventions
naltrexone, placebo
Drug
Lead sponsor
Mclean Hospital
Other
Eligibility
21 Years to 55 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2011
U.S. locations
1
States / cities
Belmont, Massachusetts
Source: ClinicalTrials.gov public record
Updated Oct 25, 2013 · Synced Oct 4, 2026, 8:07 AM EDT
Completed Phase 2 Interventional

Study to Evaluate the Subjective Effects of PTI-801 in Non-Physically Dependent Subjects With a History of Drug Abuse

NCT00734461
View directory record Official record
Conditions
Opioid-Related Disorders
Interventions
oxycodone and naltrexone
Drug
Lead sponsor
Pain Therapeutics
Industry
Eligibility
18 Years to 65 Years
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated May 2, 2016 · Synced Oct 4, 2026, 8:07 AM EDT
Completed Not applicable Interventional Results available

Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade

NCT01822132
View directory record Official record
Conditions
Methamphetamine Abuse, HIV
Interventions
Extended release naltrexone, Placebo
Drug
Lead sponsor
Oregon Health and Science University
Other
Eligibility
18 Years to 55 Years
Enrollment
76 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
2
States / cities
Portland, Oregon
Source: ClinicalTrials.gov public record
Updated Mar 5, 2019 · Synced Oct 4, 2026, 8:07 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults

NCT06216132
View directory record Official record
Conditions
Opioid Use Disorder
Interventions
BIOPIN-6 Active Implant with Naltrexone, BIOPIN-6 Placebo Implant
Combination Product · Device
Lead sponsor
Akyso Therapeutics, LLC
Industry
Eligibility
18 Years to 55 Years
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2025
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Apr 28, 2026 · Synced Oct 4, 2026, 8:07 AM EDT
Completed Not applicable Interventional Results available

Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo

NCT02317744
View directory record Official record
Conditions
Binge Eating Disorder
Interventions
Naltrexone and bupropion combination, Pill Placebo
Drug · Other
Lead sponsor
Yale University
Other
Eligibility
21 Years to 65 Years
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Dec 22, 2017 · Synced Oct 4, 2026, 8:07 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Efficacy of Naltrexone in Women's Smoking Cessation

NCT00271024
View directory record Official record
Conditions
Smoking, Smoking Cessation
Interventions
Naltrexone (drug), Placebo (for Naltrexone)
Drug
Lead sponsor
University of Chicago
Other
Eligibility
18 Years to 65 Years
Enrollment
333 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2005 – 2010
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Mar 23, 2023 · Synced Oct 4, 2026, 8:07 AM EDT
Completed Phase 3 Interventional Results available

A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

NCT01571362
View directory record Official record
Conditions
Chronic Pain, Low Back Pain, Analgesia
Interventions
ALO-02, Placebo
Drug
Lead sponsor
Pfizer
Industry
Eligibility
18 Years and older
Enrollment
410 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
52
States / cities
Mobile, Alabama • Goodyear, Arizona • Phoenix, Arizona + 38 more
Source: ClinicalTrials.gov public record
Updated Apr 4, 2017 · Synced Oct 4, 2026, 8:07 AM EDT
Completed No phase listed Observational Accepts healthy volunteers

Food Reward in Native American Women

NCT01623440
View directory record Official record
Conditions
Obesity
Interventions
Placebo and fMRI, Naltrexone and fMRI
Combination Product
Lead sponsor
University of Minnesota
Other
Eligibility
18 Years to 45 Years · Female only
Enrollment
69 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009 – 2015
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Jul 12, 2019 · Synced Oct 4, 2026, 8:07 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

Effects of Naltrexone on Nocturnal Breathing Patterns at Altitude

NCT05037032
View directory record Official record
Conditions
Altitude, Sleep Apnea, Central
Interventions
Naltrexone Pill, Placebo
Drug
Lead sponsor
VA Loma Linda Health Care System
Federal
Eligibility
18 Years to 35 Years
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021
U.S. locations
1
States / cities
Loma Linda, California
Source: ClinicalTrials.gov public record
Updated Apr 26, 2023 · Synced Oct 4, 2026, 8:07 AM 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 4, 2026, 8:07 AM EDT
Completed Phase 2 Interventional Results available

The Efficacy of Low Dose Naltrexone Therapy in Children With Crohn's Disease

NCT00715117
View directory record Official record
Conditions
Crohn's Disease
Interventions
Naltrexone, Placebo, sugar pill
Drug · Other
Lead sponsor
Milton S. Hershey Medical Center
Other
Eligibility
6 Years to 17 Years
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2010
U.S. locations
1
States / cities
Hershey, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Sep 6, 2018 · Synced Oct 4, 2026, 8:07 AM EDT
Completed Phase 3 Interventional

Medication and Counseling for Controlled Drinking (Project SMART)

NCT00444418
View directory record Official record
Conditions
Alcohol-related Disorders, Alcohol Drinking, Alcoholism, Alcohol Abuse
Interventions
Naltrexone, Modified Behavioral Self-Control Psychotherapy, Brief Behavioral Compliance Enhancement Therapy
Drug · Behavioral
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Eligibility
18 Years to 65 Years · Male only
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2010
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated May 1, 2013 · Synced Oct 4, 2026, 8:07 AM EDT
Completed Phase 3 Interventional Results available

Naltrexone & SSRI in Alcoholics With Depression/PTSD

NCT00338962
View directory record Official record
Conditions
Alcoholism, Depression, PTSD
Interventions
paroxetine, desipramine, Naltrexone, Placebo
Drug
Lead sponsor
Yale University
Other
Eligibility
21 Years to 75 Years
Enrollment
88 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2015
U.S. locations
1
States / cities
West Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Feb 5, 2016 · Synced Oct 4, 2026, 8:07 AM EDT
Completed Phase 2 Interventional

Addition of Naltrexone to Methadone Taper

NCT00135759
View directory record Official record
Conditions
Heroin Dependence, Opioid-Related Disorders, Substance-Related Disorders
Interventions
naltrexone, Placebo comparator
Drug
Lead sponsor
National Institute on Drug Abuse (NIDA)
NIH
Eligibility
18 Years to 65 Years
Enrollment
174 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2006
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Jan 12, 2017 · Synced Oct 4, 2026, 8:07 AM EDT