Drug
Naltrexone clinical trials
Also written Revia, Vivitrol and NB32.
Includes 37 studies of Vivitrol.
How each study uses Naltrexone is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
Get an email when these change. Save the Naltrexone studies recruiting or about to start — once a week, free: studies that open, close, add sites or post results.
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Example · made-up studies
Breast cancer · Recruiting: 2 came in, 3 changed
What changed in your saved searches, Oct 31 – Nov 6:
A study of drug A after surgery for early breast cancer
Came in · now Recruiting
Drug B with hormone therapy in advanced breast cancer
Changed
· Sites: 4 added, including Seoul and Busan
· Enrollment: 300 → 450 participants
Exercise during chemotherapy
Now Active, not recruiting
One email a week for all your saved searches. Stop any time.
Approvals
The first approval found in each region, with its record
- United States
- 20 Nov 1984 · REVIA · NDA 018932 (FDA, Drugs@FDA)
- European Union
- 26 Mar 2015 · Mysimba · EMEA/H/C/003687 (EMA; in a combination)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
318 studies that test it; most in 2021 (21); 2 more planned to start later
| Year | Studies |
|---|---|
| 1992 | 1 |
| 1993 | 2 |
| 1995 | 2 |
| 1997 | 4 |
| 1998 | 5 |
| 1999 | 2 |
| 2000 | 6 |
| 2001 | 3 |
| 2002 | 5 |
| 2003 | 11 |
| 2004 | 4 |
| 2005 | 10 |
| 2006 | 16 |
| 2007 | 20 |
| 2008 | 16 |
| 2009 | 11 |
| 2010 | 10 |
| 2011 | 14 |
| 2012 | 17 |
| 2013 | 14 |
| 2014 | 13 |
| 2015 | 11 |
| 2016 | 19 |
| 2017 | 14 |
| 2018 | 10 |
| 2019 | 6 |
| 2020 | 12 |
| 2021 | 21 |
| 2022 | 8 |
| 2023 | 7 |
| 2024 | 8 |
| 2025 | 4 |
| 2026 | 12 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 55 · Other 274
Yale University (24) · University of Pennsylvania (20) · Orexigen Therapeutics, Inc (13) · Alkermes, Inc. (12) · New York State Psychiatric Institute (10) · NYU Langone Health (8) · University of Minnesota (8) · National Institute on Alcohol Abuse and Alcoholism (NIAAA) (8)
Often tested with
Tested in the same studies.
Bupropion (22) · Buprenorphine (12) · Acetaminophen (6) · Topiramate (5) · Naloxone (5) · Ketamine (4) · Oxycodone (4) · Bupropion Hydrochloride Controlled-release (3)
Related medicines
As reviewed, each with the page that says it.
- One of Opioid antagonists source
Coming up
From the study records. Dates are the sponsors’ own estimates and often move.
Reaching primary completion within a year · 12, 1 in phase 3
Studies that test Naltrexone, phase 3 first.
- Apr 2027Evaluate the Efficacy and Safety of Naltrexone Hydrochloride Implant in Patients With Alcohol Use DisorderPhase 3 · Shenzhen Sciencare Medical Industries Co., Ltd.
- Dec 2026Naltrexone Neuroimaging in Teens With Eating DisordersEarly Phase 1 · Children's Mercy Hospital Kansas City
- Dec 2026Predicting Response to Naltrexone With Eye Tracking in Gaming DisorderPhase 2 · University of Sao Paulo
- Dec 2026Low-Dose Naltrexone for the Treatment of Painful Diabetic NeuropathyPhase 2 · Dartmouth-Hitchcock Medical Center
- Dec 2026Opioids and Social Support Enhanced Extinction EffectsEarly Phase 1 · University of California, Los Angeles
- Dec 2026Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)Phase 2 · NYU Langone Health
- Feb 2027Trial to Evaluate the Effects of Naltrexone in Nonsuicidal Self-injuryPhase 2 · Seoul National University Hospital
- Jun 2027Low Dose Naltrexone for Pain in Patients With HIVPhase 4 · Emory University
- Jul 2027Low-Dose Naltrexone for the Treatment of Complex Regional Pain SyndromeNot applicable · Stanford University
- Jul 2027A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for VulvodyniaPhase 2 · University of Florida
Studies
Open first, then newest update. How each study uses Naltrexone is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 329
- Low Dose Naltrexone Therapy for Complex Regional Pain SyndromeEnrolling by invitationPhase 4Hospital for Special Surgery, New YorkNCT06306157Written as Low dose naltrexone
- The Study of Brave-LC LDN Treatment TrialNot yet recruitingPhase 3National Institute of Allergy and Infectious Diseases (NIAID)NCT07916259Written as naltrexone
- Opioids and Social Support Enhanced Extinction EffectsEnrolling by invitationEarly Phase 1University of California, Los AngelesNCT04166071Written as Naltrexone
- LIFT: Life Improvement TrialRecruitingPhase 2Brigham and Women's HospitalNCT06366724Written as Low-Dose Naltrexone
- A Pilot Study on the Efficacy of Oral Low Dose Naltrexone for VulvodyniaNot yet recruitingPhase 2University of FloridaNCT07862400Written as Low Dose Naltrexone
- Low-Dose Naltrexone For ME/CFS: Dose-FindingNot yet recruitingPhase 2University of Alabama at BirminghamNCT07285473Written as Low-Dose Naltrexone, 1.5mg
- Sex Differences in Trauma, Inflammation and Brain Function and the Implications for Treatment Efficacy in Alcohol Use DisorderRecruitingPhase 4Milky KohnoNCT06426303Written as Naltrexone
- Combination Therapy for Alcohol Use DisorderNot yet recruitingPhase 2Johns Hopkins UniversityNCT07249554Written as Naltrexone (oral tablets)
- Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent PersonsNot yet recruitingPhase 2Go Medical Industries Pty LtdNCT05382091Written as naltrexone implant
- Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery PatientsNot yet recruitingPhase 1Medical University of South CarolinaNCT07224087Written as Naltrexone Hydrochloride
- Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)RecruitingPhase 2University of ArkansasNCT07224009Written as Naltrexone
- Predicting Response to Naltrexone With Eye Tracking in Gaming DisorderRecruitingPhase 2University of Sao PauloNCT04649892Written as Naltrexone
- Emergency Department-Initiated Medications for Alcohol Use DisorderRecruitingPhase 3Yale UniversityNCT05827159Written as Naltrexone Pill
- A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery PatientsNot yet recruitingPhase 1/2Medical University of South CarolinaNCT07398404Written as Naltrexone hydrochloride
- Naltrexone for Nonsuicidal Self-InjuryNot yet recruitingNot applicableSeoul National University HospitalNCT07641283Written as Naltrexone 50mg (Whanin Naltrexone Tab. 50mg)
- Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT)Enrolling by invitationPhase 1/2Truway Health, Inc.NCT07221565Written as Low-Dose Naltrexone (LDN)
- Trial to Evaluate the Effects of Naltrexone in Nonsuicidal Self-injuryNot yet recruitingPhase 2Seoul National University HospitalNCT06622239Written as Naltrexone
- Low-Dose Naltrexone for the Treatment of Painful Diabetic NeuropathyRecruitingPhase 2Dartmouth-Hitchcock Medical CenterNCT04678895Written as Naltrexone
- Low Dose Naltrexone Use in Patients With POTSNot yet recruitingPhase 4University of CalgaryNCT05363514Written as Low Dose Naltrexone
- Low Dose Naltrexone for Pain in Patients With HIVRecruitingPhase 4Emory UniversityNCT05537935Written as Low Dose Naltrexone
See all 329 studies that test Naltrexone →
Given beside what is tested · 24 — Naltrexone is usual care or a partner of the new treatment
- Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)RecruitingPhase 2Stanford UniversityNCT05940324Written as Naltrexone Pill
- A Trial to Investigate the Effects of Cannabidiol Plus Naltrexone on Alcohol Craving in Patients With Alcohol DependenceRecruitingPhase 2Central Institute of Mental Health, MannheimNCT06845124Written as Naltrexone (drug)
- Naltrexone and Propranolol Combined With ImmunotherapyRecruitingPhase 1Sarah WeissNCT05968690Written as Naltrexone
- Combination Gerotherapeutic Interventions for Healthspan ImprovementCompletedPhase 3AgelessRxNCT07475546Written as Naltrexone
- Lemborexant Augmentation of Naltrexone for Alcohol Craving and SleepCompletedPhase 3Baylor College of MedicineNCT05458609Written as Naltrexone
- Long-acting Naltrexone for Pre-release PrisonersCompletedPhase 3Friends Research Institute, Inc.NCT02867124Written as XR-NTX
- Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101)CompletedPhase 1Ensysce BiosciencesNCT02454712Written as Naltrexone Hydrochloride
- Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101)CompletedPhase 1Ensysce BiosciencesNCT05090280Written as Naltrexone Hydrochloride
- Evaluation of Oral PF614 Relative to OxyContin (PF614-102)CompletedPhase 1Ensysce BiosciencesNCT05043766Written as Naltrexone Hydrochloride
- Oxytocin and Naltrexone: Investigation of Combined Effects on Stress- and Alcohol Cue-induced Craving in Alcohol Use DisorderCompletedPhase 2/3Central Institute of Mental Health, MannheimNCT05093296Written as Naltrexone Pill
- Individualized Obesity PharmacotherapyCompletedPhase 3Mayo ClinicNCT03374956Written as Naltrexone/bupropion
- Glutamate and Opioid Mechanisms of Antidepressant Response to KetamineCompletedEarly Phase 1King's College LondonNCT04977674Written as Naltrexone
- Medication Maintenance Therapy in Community Pharmacy SettingsStatus unknownPhase 2/3LifespanNCT04139213Written as injectable naltrexone
- Improving Treatment Outcomes for Prescription Opioid DependenceCompletedPhase 2/3University of ArkansasNCT02543944Written as Naltrexone (oral)
- Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid DependenceCompletedPhase 2New York State Psychiatric InstituteNCT02437344Written as Naltrexone titration and XR-NTX initiation
- Study of a Novel Subcutaneous Depot Formulation of BuprenorphineCompletedPhase 1Indivior Inc.NCT03715634Written as Nalorex
- Memantine as a Supplement to Naltrexone in Treating Heroin DependenceCompletedPhase 2/3New York State Psychiatric InstituteNCT00476242Written as Vivitrol
- Memantine and Naltrexone Treatment for Opioid DependenceCompletedPhase 2New York State Psychiatric InstituteNCT00125515Written as Naltrexone
- Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy VolunteersCompletedPhase 1Pain TherapeuticsNCT02165930Written as Naltrexone
- Exploratory Bioavailability of Fentanyl Sublingual Spray Under Fasting ConditionsCompletedNot applicableINSYS Therapeutics IncNCT02138396Written as Naltrexone
Showing 20 of 24.
As the comparator · 10 — what is tested is compared with Naltrexone
- Safety and PK Study of BICX104 With or Without Bupropion Compared to VivitrolRecruitingPhase 1BioCorRx Pharmaceuticals IncNCT07269873Written as Naltrexone (depot)
- A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.RecruitingPhase 1Inventage Lab., Inc.NCT05620940Written as Vivitrol Injectable Product
- Naltrexone for Prolonged Grief DisorderTerminatedPhase 4Texas Tech UniversityNCT06140420Written as Naltrexone Oral Product
- Extended Release Naltrexone Versus Extended Release Buprenorphine With Individuals Leaving JailActive, not recruitingPhase 2/3Friends Research Institute, Inc.NCT04408313Written as XR-NTX
- A Research Study Comparing Wegovy to Other Weight Management Drugs in People Living With Obesity in AmericaCompletedPhase 4Novo Nordisk A/SNCT05579249Written as Naltrexone/Bupropion
- Brain Mechanisms of Pharmacotherapy in Opioid Use DisorderTerminatedPhase 2University of PennsylvaniaNCT04454411Written as Vivitrol
- Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol InjectionsCompletedPhase 1BioCorRx IncNCT04828694Written as Vivitrol
- Re-entry XR-NTX for Rural Individuals With Opioid Use DisorderCompletedEarly Phase 1Michele StatonNCT03447743Written as XR-NTX community location
- Pharmacokinetics of SP-104CompletedPhase 1Scilex Pharmaceuticals, Inc.NCT05002946Written as Naltrexone Hydrochloride 50Mg Oral Tablet
- Effects of Omegas 3 and 6 on Alcohol DependenceCompletedPhase 3Federal University of São PauloNCT01211769Written as Naltrexone
What changed recently
From the registry's own updates since Oct 16, 2026.
Newly registered1
- The Study of Brave-LC LDN Treatment TrialNov 4, 2026NCT07916259
Codes
What other systems call Naltrexone · ClinicalTrials.gg INT007867
- MeSH (NLM) D009271NaltrexoneConfirmed ClinicalTrials.gov, NLM, Wikidata
- UNII (FDA) 5S6W795CQMNALTREXONEConfirmed FDA, NLM, Wikidata
- RxNorm 7243Confirmed FDA, Wikidata
- Wikidata Q409587naltrexoneConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C62055NaltrexoneOne source FDA
- DrugBank DB00704One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | D009271 | Naltrexone | Confirmed ClinicalTrials.gov, NLM, Wikidata |
| UNII (FDA) | 5S6W795CQM | NALTREXONE | Confirmed FDA, NLM, Wikidata |
| RxNorm | 7243 | — | Confirmed FDA, Wikidata |
| Wikidata | Q409587 | naltrexone | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C62055 | Naltrexone | One source FDA |
| DrugBank | DB00704 | — | One source Wikidata |
Also registered as naltrexone hydrochloride (UNII Z6375YW9SF · RxNorm 105069).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.