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ClinicalTrials.gov public records Last synced Oct 19, 2026, 1:37 AM EDT

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Showing 1–24 of 130 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Oral Naltrexone Clear all
Withdrawn Phase 4 Interventional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 19, 2026, 1:37 AM EDT
Completed Phase 2 Interventional

Naltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain

NCT01415895
View directory record Official record
Conditions
Back Pain, Lower Back Pain, Cervical Pain
Interventions
Naltrexone and Clonidine Combination, placebo
Drug
Lead sponsor
Annette C. Toledano MD
Industry
Eligibility
19 Years to 70 Years
Enrollment
78 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
1
States / cities
North Miami, Florida
Source: ClinicalTrials.gov public record
Updated Apr 14, 2021 · Synced Oct 19, 2026, 1:37 AM EDT
Recruiting Phase 1 Interventional Accepts healthy volunteers

Safety and PK Study of BICX104 With or Without Bupropion Compared to Vivitrol

NCT07269873
View directory record Official record
Conditions
Healthy Adult Male and Female Volunteers
Interventions
BICX104 naltrexone implantable pellet, Bupropion 150 mg XL, Naltrexone (depot)
Drug
Lead sponsor
BioCorRx Pharmaceuticals Inc
Other
Eligibility
18 Years to 65 Years
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated May 13, 2026 · Synced Oct 19, 2026, 1:37 AM EDT
Completed No phase listed Observational Results available

Real-World Evidence on the Cardiovascular Safety of CONTRAVE® in the United States (U.S.)

NCT06090461
View directory record Official record
Conditions
Obesity
Interventions
Not listed
Lead sponsor
Currax Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
31,889 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2022
U.S. locations
1
States / cities
Brentwood, Tennessee
Source: ClinicalTrials.gov public record
Updated Jun 25, 2025 · Synced Oct 19, 2026, 1:37 AM EDT
Not yet recruiting Phase 2 Interventional

Combination Therapy for Alcohol Use Disorder

NCT07249554
View directory record Official record
Conditions
Alcohol Use Disorder
Interventions
Placebo, Glucagon-Like Peptide-1 Agonist (GLP-1), Naltrexone (oral tablets)
Drug
Lead sponsor
Johns Hopkins University
Other
Eligibility
21 Years to 65 Years
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
Havre de Grace, Maryland
Source: ClinicalTrials.gov public record
Updated Oct 1, 2026 · Synced Oct 19, 2026, 1:37 AM EDT
Not yet recruiting Phase 2 Interventional

A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for Vulvodynia

NCT07862400
View directory record Official record
Conditions
Vulvodynia
Interventions
Low Dose Naltrexone
Drug
Lead sponsor
University of Florida
Other
Eligibility
18 Years to 99 Years · Female only
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2027 – 2028
U.S. locations
2
States / cities
Jacksonville, Florida
Source: ClinicalTrials.gov public record
Updated Oct 9, 2026 · Synced Oct 19, 2026, 1:37 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 19, 2026, 1:37 AM EDT
Completed Phase 2 Interventional

Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1

NCT00238914
View directory record Official record
Conditions
Heroin Dependence
Interventions
Naltrexone, Behavioral Naltrexone Therapy (BNT), Compliance Enhancement (CE)
Drug · Behavioral
Lead sponsor
New York State Psychiatric Institute
Other
Eligibility
18 Years to 60 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2002
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jan 13, 2012 · Synced Oct 19, 2026, 1:37 AM EDT
Completed No phase listed Observational

MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study

NCT03718104
View directory record Official record
Conditions
Opioid-use Disorder, Neonatal Abstinence Syndrome, Pregnancy, High Risk, Alcohol Use Disorder
Interventions
Pharmacokinetic analysis, Safety and Efficacy, Genetic and epigenetic analysis, Breast milk analysis
Other · Genetic
Lead sponsor
Boston Medical Center
Other
Eligibility
18 Years and older · Female only
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2024
U.S. locations
2
States / cities
Boston, Massachusetts • Carrboro, North Carolina
Source: ClinicalTrials.gov public record
Updated Nov 4, 2024 · Synced Oct 19, 2026, 1:37 AM EDT
Not listed Phase 3 Interventional

Medication and Counseling for Controlled Drinking

NCT01115894
View directory record Official record
Conditions
Alcohol Dependence, Alcohol Abuse
Interventions
Naltrexone, Modified Behavioral Self-Control Psychotherapy, Brief Behavioral Compliance Enhancement Therapy, Placebo
Drug · Behavioral
Lead sponsor
Research Foundation for Mental Hygiene, Inc.
Other
Eligibility
18 Years to 65 Years · Male only
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2007
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Dec 10, 2012 · Synced Oct 19, 2026, 1:37 AM EDT
Terminated Phase 4 Interventional Results available

EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial

NCT04531176
View directory record Official record
Conditions
Type 2 Diabetes, Obesity
Interventions
Weight Management Program (WMP), Traditional care, Phentermine / Topiramate Extended Release Oral Capsule, naltrexone/bupropion extended-release, liraglutide 3.0 mg, Orlistat
Other · Drug
Lead sponsor
The Cleveland Clinic
Other
Eligibility
18 Years to 75 Years
Enrollment
74 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Sep 19, 2024 · Synced Oct 19, 2026, 1:37 AM EDT
Terminated Phase 4 Interventional Results available

Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients

NCT01100437
View directory record Official record
Conditions
Chronic Pain
Interventions
EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush, EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole
Drug
Lead sponsor
Pfizer
Industry
Eligibility
21 Years and older
Enrollment
14 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Jul 13, 2012 · Synced Oct 19, 2026, 1:37 AM EDT
Completed Phase 2 Interventional Results available

Impact of Colchicine and Low-dose Naltrexone on COVID-19

NCT04756128
View directory record Official record
Conditions
Covid19
Interventions
Colchicine 0.6 mg, Naltrexone
Drug
Lead sponsor
HealthPartners Institute
Other
Eligibility
18 Years and older
Enrollment
142 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
2
States / cities
Saint Louis Park, Minnesota • Saint Paul, Minnesota
Source: ClinicalTrials.gov public record
Updated Jul 25, 2023 · Synced Oct 19, 2026, 1:37 AM 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 19, 2026, 1:37 AM EDT
Not listed Phase 3 Interventional

Assessing Long Term Safety and Tolerability of PXT3003 in Patients With Charcot-Marie-Tooth Disease Type 1A

NCT03023540
View directory record Official record
Conditions
Charcot-Marie-Tooth Disease, Type IA
Interventions
PXT3003
Drug
Lead sponsor
Pharnext S.C.A.
Other
Eligibility
17 Years to 67 Years
Enrollment
187 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2024
U.S. locations
9
States / cities
Los Angeles, California • Gainesville, Florida • Kansas City, Kansas + 6 more
Source: ClinicalTrials.gov public record
Updated Feb 20, 2024 · Synced Oct 19, 2026, 1:37 AM EDT
Completed Not applicable Interventional Results available

Naltrexone for Antipsychotic-Induced Weight Gain

NCT01866098
View directory record Official record
Conditions
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Bipolar Disorder, Severe Major Depression With Psychotic Features
Interventions
Naltrexone, Placebo
Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years to 75 Years
Enrollment
144 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2019
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Oct 1, 2021 · Synced Oct 19, 2026, 1:37 AM EDT
Completed Phase 4 Interventional

Targeted Naltrexone for Problem Drinkers

NCT00369408
View directory record Official record
Conditions
Alcoholism, Alcohol Drinking, Alcohol Dependence
Interventions
Naltrexone, placebo
Drug
Lead sponsor
UConn Health
Other
Eligibility
18 Years to 70 Years
Enrollment
163 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2008
U.S. locations
1
States / cities
Farmington, Connecticut
Source: ClinicalTrials.gov public record
Updated Jun 20, 2011 · Synced Oct 19, 2026, 1:37 AM EDT
Recruiting Phase 4 Interventional

Low Dose Naltrexone for Pain in Patients With HIV

NCT05537935
View directory record Official record
Conditions
Human Immunodeficiency Virus, Chronic Neuropathic Pain
Interventions
Low Dose Naltrexone
Drug
Lead sponsor
Emory University
Other
Eligibility
18 Years to 75 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
3
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Apr 9, 2026 · Synced Oct 19, 2026, 1:37 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Addiction Treatment in Russia: Oral vs. Naltrexone Implant

NCT00218426
View directory record Official record
Conditions
Heroin Dependence, Opioid-Related Disorders
Interventions
naltrexone implant, oral naltrexone, oral placebo naltrexone, placebo implant
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years to 50 Years
Enrollment
306 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2010
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Mar 18, 2019 · Synced Oct 19, 2026, 1:37 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 19, 2026, 1:37 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study

NCT01359930
View directory record Official record
Conditions
Methamphetamine Dependence
Interventions
placebo, Naltrexone and Bupropion SR
Other · Drug
Lead sponsor
National Institute on Drug Abuse (NIDA)
NIH
Eligibility
21 Years to 50 Years
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2011 – 2012
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Jan 12, 2017 · Synced Oct 19, 2026, 1:37 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Dose Proportionality Study Of PF-00345439 Formulation Under Fed Conditions

NCT02089295
View directory record Official record
Conditions
Healthy
Interventions
Oxycodone
Drug
Lead sponsor
Pain Therapeutics
Industry
Eligibility
18 Years to 55 Years
Enrollment
18 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
2
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Apr 4, 2016 · Synced Oct 19, 2026, 1:37 AM 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 19, 2026, 1:37 AM EDT
Withdrawn Phase 3 Interventional Accepts healthy volunteers

Comparison of Three Opioid Detoxification Treatment Regimens

NCT03678792
View directory record Official record
Conditions
Opioid-Related Disorders, Opioid Withdrawal
Interventions
Buprenorphine/naloxone, Morphine, Tramadol
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
18 Years to 65 Years
Healthy volunteers
Accepts healthy volunteers
Timeline
2019 – 2020
U.S. locations
1
States / cities
Richmond, Virginia
Source: ClinicalTrials.gov public record
Updated Nov 5, 2019 · Synced Oct 19, 2026, 1:37 AM EDT