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

Medication and Counseling for Controlled Drinking (Project SMART)

Phase 3

Completed

Conditions: Alcohol-related Disorders
Alcohol Drinking
Alcoholism
Alcohol Abuse

Interventions: Drug: Naltrexone
Behavioral: Modified Behavioral Self-Control Psychotherapy
Behavioral: Brief Behavioral Compliance Enhancement Therapy

First Posted Date: 2007-03-07

Last Posted Date: 2013-05-01

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

Target Recruit Count: 200

Registration Number: NCT00444418

Locations: 🇺🇸
Research Foundation for Mental Hygiene, Columbia Addiction Services and Psychotherapy Intervention Research, 3 Columbus Circle, Suite 1404, New York, New York, United States

Substance Abuse Pre-Treatment Screening Study

Recruiting

Conditions: Cocaine Abuse
Alcohol Dependence
Cocaine Dependence
Substance Abuse
Opiate Dependence

Interventions: Drug: modafinil
Drug: d-amphetamine
Drug: L-Dopa
Drug: Naltrexone

First Posted Date: 2007-02-22

Last Posted Date: 2023-12-20

Lead Sponsor: The University of Texas Health Science Center, Houston

Target Recruit Count: 7500

Registration Number: NCT00439049

Locations: 🇺🇸
University of Texas Medical School- Houston, Dept. of Psychiatry Mental Sciences Institute, Houston, Texas, United States

HIV Risk Reduction and Drug Abuse Treatment in Iran

Phase 2

Withdrawn

Conditions: Opiate Dependence
HIV Infections

Interventions: Drug: Buprenorphine/Subutex
Drug: Naltrexone
Behavioral: Drug counseling

First Posted Date: 2006-11-10

Last Posted Date: 2020-03-30

Lead Sponsor: Yale University

Registration Number: NCT00398008

Locations: 🇺🇸
Yale University School of Medicine, New Haven, Connecticut, United States
🇮🇷
Institute for Cognitive Studies, Tehran, Iran, Islamic Republic of

HIV Risk Reduction and Drug Abuse Treatment in Malaysia

Phase 2

Completed

Conditions: Opiate Dependence

First Posted Date: 2006-10-02

Last Posted Date: 2020-03-31

Lead Sponsor: Yale University

Target Recruit Count: 180

Registration Number: NCT00383045

Locations: 🇺🇸
Yale University School of Medicine, New Haven, Connecticut, United States
🇲🇾
Substance Abuse Research Center, Muar, Johor, Malaysia

Phase II of Naltrexone in Hormone-Refractory Metastatic Breast Cancer

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Drug: naltrexone
Procedure: PET scan

First Posted Date: 2006-09-21

Last Posted Date: 2017-12-28

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 13

Registration Number: NCT00379197

Locations: 🇺🇸
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States

Targeted Naltrexone for Problem Drinkers

Phase 4

Completed

Conditions: Alcoholism
Alcohol Drinking
Alcohol Dependence

Interventions: Drug: placebo
Drug: Naltrexone

First Posted Date: 2006-08-29

Last Posted Date: 2011-06-20

Lead Sponsor: UConn Health

Target Recruit Count: 163

Registration Number: NCT00369408

Locations: 🇺🇸
University of Connecticut Health Center, Farmington, Connecticut, United States

Effectiveness of Naltrexone Versus Placebo to Reduce Craving for Alcohol With Evaluation of Genetic Variability.

Phase 4

Completed

Conditions: Alcohol Dependence

Interventions: Drug: Naltrexone
Drug: Placebo

First Posted Date: 2006-08-21

Last Posted Date: 2017-06-05

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 83

Registration Number: NCT00366626

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

Naltrexone & SSRI in Alcoholics With Depression/PTSD

Phase 3

Completed

Conditions: Alcoholism
Depression
PTSD

Interventions: Drug: paroxetine
Drug: desipramine
Drug: Placebo
Drug: Naltrexone

First Posted Date: 2006-06-20

Last Posted Date: 2016-02-05

Lead Sponsor: Yale University

Target Recruit Count: 88

Registration Number: NCT00338962

Locations: 🇺🇸
VA Connecticut Healthcare Systems, West Haven, Connecticut, United States

Double-Blind Naltrexone in Kleptomania

Phase 2

Completed

Conditions: Kleptomania

Interventions: Drug: Placebo
Drug: Naltrexone

First Posted Date: 2006-06-01

Last Posted Date: 2019-07-29

Lead Sponsor: University of Minnesota

Target Recruit Count: 25

Registration Number: NCT00332579

Locations: 🇺🇸
University of Minnesota, Minneapolis, Minnesota, United States

Naltrexone in the Treatment of Concurrent Alcohol Dependence and Pathological Gambling

Not Applicable

Completed

Conditions: Concurrent Alcohol Dependence and Pathological Gambling

First Posted Date: 2006-05-17

Last Posted Date: 2006-05-17

Lead Sponsor: Centre for Addiction and Mental Health

Target Recruit Count: 50

Registration Number: NCT00326807

Locations: 🇫🇮
National Public Health Institute, Helsinki, Finland
🇨🇦
Centre for Addiction and Mental Health, Toronto, Ontario, Canada

Drug Development Updates

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

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy