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

Associated Therapies: -

Clinical Trials

Pharmacotherapy for HIV Infected Patients With Alcohol Problems

Phase 4

Withdrawn

Conditions: HIV Infection
Heavy Alcoholic Consumption
HIV Infections

Interventions: Drug: Naltrexone

First Posted Date: 2009-03-03

Last Posted Date: 2012-03-28

Lead Sponsor: VA Connecticut Healthcare System

Registration Number: NCT00854230

Pharmacogenetic Response to Naltrexone For Alcohol Dependence

Phase 4

Completed

Conditions: Alcohol Dependence

Interventions: Drug: naltrexone
Drug: Placebo

First Posted Date: 2009-01-28

Last Posted Date: 2017-05-11

Lead Sponsor: David Oslin

Target Recruit Count: 221

Registration Number: NCT00831272

Locations: 🇺🇸
Philadelphia VA Medical Center, Philadelphia, Pennsylvania, United States
🇺🇸
Geisinger Medical Center, Danville, Pennsylvania, United States
🇺🇸
University of Pennsylvania Treatment Research Center, Philadelphia, Pennsylvania, United States

and more 1 locations

Understanding Treatment Response With Naltrexone Among White Alcoholics

Phase 4

Completed

Conditions: Alcoholism

Interventions: Drug: Placebo Oral Tablet
Drug: Naltrexone

First Posted Date: 2009-01-06

Last Posted Date: 2019-11-21

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 24

Registration Number: NCT00817089

Locations: 🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

Naltrexone in the Treatment of Trichotillomania

Phase 2

Completed

Conditions: Trichotillomania

Interventions: Drug: Placebo
Drug: Naltrexone

First Posted Date: 2008-10-20

Last Posted Date: 2023-02-23

Lead Sponsor: University of Chicago

Target Recruit Count: 51

Registration Number: NCT00775229

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States

The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse

Phase 2

Completed

Conditions: Smoking

Interventions: Drug: placebo
Drug: naltrexone
Drug: varenicline

First Posted Date: 2008-10-16

Last Posted Date: 2018-04-23

Lead Sponsor: Yale University

Target Recruit Count: 30

Registration Number: NCT00773422

Locations: 🇺🇸
Yale Center for Clinical Investigation, Yale University, New Haven, Connecticut, United States

Effects of Low-dose Naltrexone in Combination With a Range of Smoked Marijuana

Phase 2

Completed

Conditions: Marijuana Smoking

Interventions: Drug: Active Marijuana (5.5% THC)
Drug: Inactive Marijuana (0% THC)
Drug: Active Marijuana (6.2% THC)
Drug: Placebo naltrexone
Drug: Naltrexone

First Posted Date: 2008-08-28

Last Posted Date: 2018-09-14

Lead Sponsor: New York State Psychiatric Institute

Target Recruit Count: 23

Registration Number: NCT00743145

Locations: 🇺🇸
New York State Psychiatric Institute, New York, New York, United States

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

Phase 2

Completed

Conditions: Crohn's Disease

Interventions: Other: Placebo, sugar pill
Drug: Naltrexone

First Posted Date: 2008-07-15

Last Posted Date: 2018-09-06

Lead Sponsor: Milton S. Hershey Medical Center

Target Recruit Count: 14

Registration Number: NCT00715117

Locations: 🇺🇸
Penn State University hershey Medical center, Hershey, Pennsylvania, United States

Effectiveness of Alcohol Interventions Among Tuberculosis (TB) Patients in Tomsk Oblast, Russia

Not Applicable

Completed

Conditions: Alcohol Use Disorders
Tuberculosis

Interventions: Other: BCI + Naltrexone
Behavioral: Brief Counseling Intervention (BCI)
Drug: Naltrexone
Behavioral: Treatment as Usual

First Posted Date: 2008-05-12

Last Posted Date: 2017-10-25

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 400

Registration Number: NCT00675961

Locations: 🇷🇺
Tomsk Oblast TB Services, Tomsk, Tomsk Oblast, Russian Federation

The Effect of Naltrexone on Alcohol Craving and on Brain Activity During Alcohol Infusion

Early Phase 1

Completed

Conditions: Alcoholism
Alcohol Dependence

First Posted Date: 2008-04-28

Last Posted Date: 2017-07-02

Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Target Recruit Count: 70

Registration Number: NCT00667771

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence

Phase 2

Completed

Conditions: Alcohol Dependence

Interventions: Drug: Placebo
Drug: Naltrexone
Drug: Naltrexone + Aripiprazole

First Posted Date: 2008-04-28

Last Posted Date: 2017-09-29

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 65

Registration Number: NCT00667875

Locations: 🇺🇸
Medical University of South Carolina, Center for Drug and Alcohol Programs, Charleston, South Carolina, United States

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2024. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy