DeepMed Research

Naltrexone

Generic Name: Naltrexone

Brand Names: Contrave, Embeda, Vivitrol

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₃NO_₄

CAS Number: 16590-41-3

Unique Ingredient Identifier: 5S6W795CQM

Background: Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of naloxone. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.

Indication: Used as an adjunct to a medically supervised behaviour modification program in the maintenance of opiate cessation in individuals who were formerly physically dependent on opiates and who have successfully undergone detoxification. Also used for the management of alcohol dependence in conjunction with a behavioural modification program.

Associated Conditions: Alcohol Dependency, Cholestatic pruritus, Obesity, Opioid Dependence, Severe Pain

Clinical Trials

Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder

Phase 3

Recruiting

Conditions: Methamphetamine Abuse
Methamphetamine-dependence

Interventions: Drug: extended-release naltrexone (XR-NTX)
Drug: iPLB
Drug: extended release bupropion (BUP-XL) tablets (BUP-XL)
Drug: oPLB

First Posted Date: 2024-01-31

Last Posted Date: 2025-05-22

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Target Recruit Count: 360

Registration Number: NCT06233799

Locations: 🇺🇸
University of Kansas Medical Center, Kansas City, Kansas, United States
🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
🇺🇸
University of California Los Angeles, Los Angeles, California, United States

and more 8 locations

Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.

Not Applicable

Not yet recruiting

Conditions: Alcohol Liver Disease

Interventions: Drug: Naltrexon
Drug: Baclofen

First Posted Date: 2023-12-19

Last Posted Date: 2023-12-19

Lead Sponsor: Institute of Liver and Biliary Sciences, India

Target Recruit Count: 110

Registration Number: NCT06175507

Locations: 🇮🇳
Institute of Liver & Biliary Sciences (ILBS), New Delhi, Delhi, India

Naltrexone for Prolonged Grief Disorder

Phase 4

Recruiting

Conditions: Naltrexone HCl 50 MG Oral Tablet
Placebo

Interventions: Drug: Placebo
Drug: Naltrexone Oral Product

First Posted Date: 2023-11-20

Last Posted Date: 2023-11-21

Lead Sponsor: Texas Tech University

Target Recruit Count: 48

Registration Number: NCT06140420

Locations: 🇺🇸
Texas Tech Health Science Center, Lubbock, Texas, United States

Naltrexone and Propranolol Combined With Immunotherapy

Phase 1

Recruiting

Conditions: Advanced Melanoma

Interventions: Drug: Propranolol
Drug: Naltrexone

First Posted Date: 2023-08-01

Last Posted Date: 2023-11-15

Lead Sponsor: Ryan Stephenson

Target Recruit Count: 12

Registration Number: NCT05968690

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia

Phase 2

Recruiting

Conditions: Vulvodynia
Naltrexone
Quality of Life

Interventions: Drug: Naltrexone Hydrochloride

First Posted Date: 2023-07-21

Last Posted Date: 2023-07-21

Lead Sponsor: Medical University of Lublin

Target Recruit Count: 300

Registration Number: NCT05955313

Locations: 🇵🇱
Terpa Limited Liability Company Limited Partnership, Lublin, Poland

Examining Mu Opioid Mechanisms of Ketamine's Rapid Effects in OCD (MKET2)

Phase 2

Recruiting

Conditions: Obsessive-Compulsive Disorder

Interventions: Drug: Ketamine
Other: Placebo pill
Drug: Naltrexone Pill

First Posted Date: 2023-07-11

Last Posted Date: 2024-12-19

Lead Sponsor: Stanford University

Target Recruit Count: 150

Registration Number: NCT05940324

Locations: 🇺🇸
Department of Psychiatry & Behavioral Sciences, Stanford, California, United States

The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer

Not Applicable

Completed

Conditions: Cornea Ulcer

Interventions: Drug: Naltrexone Hydrochloride
Drug: Carboxy methyl cellulose

First Posted Date: 2023-06-29

Last Posted Date: 2023-06-29

Lead Sponsor: Minia University

Target Recruit Count: 50

Registration Number: NCT05924893

Locations: 🇪🇬
Faculty of Medicine, Minya, Egypt

Exploring the PK of Different Doses of Naltrexone in Patients With AUD

Phase 1

Recruiting

Conditions: AUD

Interventions: Drug: Placebo
Drug: Naltrexone implant

First Posted Date: 2023-06-26

Last Posted Date: 2023-06-26

Lead Sponsor: Shenzhen Sciencare Medical Industries Co., Ltd.

Target Recruit Count: 60

Registration Number: NCT05919017

Locations: 🇨🇳
Hunan Second People's Hospital, Changsha, 湖南省, China

Emergency Department-Initiated Medications for Alcohol Use Disorder

Phase 3

Recruiting

Conditions: Alcohol Use Disorder

Interventions: Drug: Naltrexone Pill
Drug: Naltrexone Injection
Behavioral: Brief Negotiation Interview
Drug: Gabapentin Pill

First Posted Date: 2023-04-24

Last Posted Date: 2025-05-18

Lead Sponsor: Yale University

Target Recruit Count: 240

Registration Number: NCT05827159

Locations: 🇺🇸
Yale New Haven Hospital, New Haven, Connecticut, United States

A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.

Phase 1

Recruiting

Conditions: Opioid Dependence
Alcohol Dependence

Interventions: Drug: Vivitrol Injectable Product
Drug: IVL3004
Drug: IVL4002

First Posted Date: 2022-11-17

Last Posted Date: 2024-10-11

Lead Sponsor: Inventage Lab., Inc.

Target Recruit Count: 40

Registration Number: NCT05620940

Locations: 🇦🇺
Nucleus Network, Herston, Queensland, Australia

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