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ClinicalTrials.gov public records Last synced Oct 22, 2026, 6:35 AM EDT

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Showing 1–24 of 43 matching trials from the live ClinicalTrials.gov search.
Filters: Condition: Low Dose Naltrexone Clear all
Withdrawn Phase 2 Interventional

Low Dose Naltrexone for Chronic Pain in Osteoarthritis and Inflammatory Arthritis

NCT04115020
View directory record Official record
Conditions
Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Psoriatic
Interventions
Naltrexone, Placebo
Drug
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jan 9, 2020 · Synced Oct 22, 2026, 6:35 AM EDT
Completed Phase 2 Interventional Results available

Low Dose Naltrexone for Glioma Patients

NCT01303835
View directory record Official record
Conditions
Malignant Glioma
Interventions
LDN, Placebo
Drug
Lead sponsor
Katy Peters
Other
Eligibility
18 Years and older
Enrollment
110 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Jul 17, 2015 · Synced Oct 22, 2026, 6:35 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 22, 2026, 6:35 AM EDT
Completed Not applicable Interventional Results available

Effects of Low Dose Naltrexone in Fibromyalgia

NCT00568555
View directory record Official record
Conditions
Fibromyalgia, Persian Gulf Syndrome
Interventions
Low Dose Naltrexone, Placebo - sugar pill
Drug
Lead sponsor
Stanford University
Other
Eligibility
18 Years to 65 Years
Enrollment
53 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2010
U.S. locations
1
States / cities
Stanford, California
Source: ClinicalTrials.gov public record
Updated Oct 21, 2015 · Synced Oct 22, 2026, 6:35 AM EDT
Completed Phase 2 Interventional

Low-Dose Naltrexone and Acetaminophen Combination and Its Components in the Acute Treatment of Migraine

NCT03061734
View directory record Official record
Conditions
Migraine With or Without Aura
Interventions
Naltrexone and Acetaminophen, Naltrexone and Acetaminophen-High Dose, Naltrexone Alone (regular dose), Acetaminophen Alone, Matching Placebo
Drug
Lead sponsor
Allodynic Therapeutics, Inc
Industry
Eligibility
18 Years and older
Enrollment
92 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
North Miami, Florida
Source: ClinicalTrials.gov public record
Updated Apr 14, 2021 · Synced Oct 22, 2026, 6:35 AM EDT
Completed Phase 2 Interventional Results available

The Preventive Treatment of Migraine With Low-Dose Naltrexone and Acetaminophen Combination

NCT03194555
View directory record Official record
Conditions
Migraine With or Without Aura
Interventions
Low-Dose Naltrexone and Acetaminophen Combination, Placebo
Drug
Lead sponsor
Allodynic Therapeutics, Inc
Industry
Eligibility
18 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
North Miami, Florida
Source: ClinicalTrials.gov public record
Updated Apr 10, 2024 · Synced Oct 22, 2026, 6:35 AM EDT
Withdrawn Not applicable Interventional

Can The Bridge Transition Opiate Use Disorder Patients in Stable Recovery From Buprenorphine to Naltrexone

NCT03762798
View directory record Official record
Conditions
Substance Use Disorders, Substance Abuse, Substance Use, Substance Dependence
Interventions
The Bridge
Device
Lead sponsor
The Cleveland Clinic
Other
Eligibility
18 Years to 99 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Sep 23, 2021 · Synced Oct 22, 2026, 6:35 AM EDT
Active, not recruiting Phase 2 Interventional

Treating Central Neuropathic Pain With Low Dose Naltrexone for People With Spinal Cord Injury

NCT06723561
View directory record Official record
Conditions
Central Neuropathic Pain, Spinal Cord Injury
Interventions
4.5mg daily dose of naltrexone
Drug
Lead sponsor
Medical College of Wisconsin
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
1
States / cities
Milwaukee, Wisconsin
Source: ClinicalTrials.gov public record
Updated Apr 30, 2026 · Synced Oct 22, 2026, 6:35 AM EDT
Withdrawn Not applicable Interventional

Immune Effects of Low-dose Naltrexone in ME/CFS

NCT02965768
View directory record Official record
Conditions
Fatigue Syndrome, Chronic
Interventions
Naltrexone HCl
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
18 Years to 65 Years · Female only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2022
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Sep 2, 2022 · Synced Oct 22, 2026, 6:35 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 22, 2026, 6:35 AM EDT
Completed Phase 2 Interventional Results available

Low-Dose Naltrexone (LDN) for Depression Relapse and Recurrence

NCT01874951
View directory record Official record
Conditions
Major Depressive Disorder, Depression, Unipolar, Recurrence, Relapse
Interventions
Naltrexone, Placebo
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 65 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Feb 24, 2017 · Synced Oct 22, 2026, 6:35 AM EDT
Terminated Phase 2 Interventional Results available

Low Dose Naltrexone for Metastatic Melanoma, Castrate Resistant Prostate Cancer and Renal Cancer

NCT01650350
View directory record Official record
Conditions
Melanoma, Prostate Cancer, Renal Cancer
Interventions
Naltrexone
Drug
Lead sponsor
Brown University
Other
Eligibility
18 Years and older
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Mar 4, 2022 · Synced Oct 22, 2026, 6:35 AM EDT
Completed Phase 2 Interventional

Low-Dose Naltrexone and Acetaminophen Combination in the Treatment of Chronic Low Back Pain (ANODYNE-4)

NCT03201393
View directory record Official record
Conditions
Chronic Low Back Pain, Lumbar Radiculopathy
Interventions
Low-dose naltrexone and acetaminophen combination, Placebo
Drug
Lead sponsor
Allodynic Therapeutics, Inc
Industry
Eligibility
18 Years and older
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
North Miami, Florida
Source: ClinicalTrials.gov public record
Updated Apr 14, 2021 · Synced Oct 22, 2026, 6:35 AM EDT
Withdrawn Phase 2 Interventional Accepts healthy volunteers

Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

NCT01810185
View directory record Official record
Conditions
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
Interventions
Low dose naltrexone, Placebo
Drug
Lead sponsor
Santa Barbara Cottage Hospital
Other
Eligibility
18 Years and older
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2014
U.S. locations
1
States / cities
Santa Barbara, California
Source: ClinicalTrials.gov public record
Updated Nov 20, 2014 · Synced Oct 22, 2026, 6:35 AM EDT
Terminated Phase 3 Interventional Results available

Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis

NCT03970330
View directory record Official record
Conditions
Endometriosis
Interventions
Naltrexone, Norethindrone Acetate, Placebo
Drug
Lead sponsor
Milton S. Hershey Medical Center
Other
Eligibility
18 Years to 45 Years · Female only
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2021
U.S. locations
1
States / cities
Hershey, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Nov 3, 2022 · Synced Oct 22, 2026, 6:35 AM EDT
Completed Not applicable Interventional Results available

Low Dose Naltrexone (LDN) Immune Monitoring

NCT02107014
View directory record Official record
Conditions
Fibromyalgia
Interventions
Low Dose Naltrexone
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
18 Years to 65 Years · Female only
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014
U.S. locations
1
States / cities
Palo Alto, California
Source: ClinicalTrials.gov public record
Updated Apr 11, 2017 · Synced Oct 22, 2026, 6:35 AM 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 22, 2026, 6:35 AM EDT
Completed Phase 2 Interventional

Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis

NCT03482479
View directory record Official record
Conditions
Eosinophilic Granulomatosis With Polyangiitis (EGPA), Churg-Strauss Syndrome (CSS), Giant Cell Arteritis, Granulomatosis With Polyangiitis, Microscopic Polyangiitis, Polyarteritis Nodosa, Takayasu Arteritis
Interventions
Naltrexone Hydrochloride, Placebo Comparator
Drug · Other
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2025
U.S. locations
6
States / cities
Boston, Massachusetts • Rochester, Minnesota • Cleveland, Ohio + 3 more
Source: ClinicalTrials.gov public record
Updated Jan 22, 2026 · Synced Oct 22, 2026, 6:35 AM EDT
Completed Phase 3 Interventional

A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone

NCT00501696
View directory record Official record
Conditions
Multiple Sclerosis
Interventions
4.5 mg Naltrexone, Naltrexone
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years to 86 Years
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated May 19, 2008 · Synced Oct 22, 2026, 6:35 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 22, 2026, 6:35 AM EDT
Not yet recruiting Phase 2 Interventional

Low-Dose Naltrexone For ME/CFS: Dose-Finding

NCT07285473
View directory record Official record
Conditions
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Interventions
Low-Dose Naltrexone, 1.5mg, Low-Dose Naltrexone, 3.0mg, Low-Dose Naltrexone, 4.5mg, Low-Dose Naltrexone, 6.0mg
Drug
Lead sponsor
University of Alabama at Birmingham
Other
Eligibility
18 Years to 65 Years
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Oct 8, 2026 · Synced Oct 22, 2026, 6:35 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 22, 2026, 6:35 AM EDT