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

Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence

Phase 2

Completed

Conditions: Alcohol-Related Disorders
Alcoholism
Cocaine-Related Disorders

Interventions: Drug: Naltrexone
Drug: Placebo
Drug: Modafinil

First Posted Date: 2005-09-02

Last Posted Date: 2020-07-16

Lead Sponsor: Kyle Kampman

Target Recruit Count: 164

Registration Number: NCT00142818

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

Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1

Phase 2

Completed

Conditions: Cocaine-Related Disorders
Alcohol-Related Disorders
Alcoholism

Interventions: Drug: Placebo
Drug: Naltrexone
Drug: Disulfiram

First Posted Date: 2005-09-02

Last Posted Date: 2017-01-12

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 208

Registration Number: NCT00142844

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

Addition of Naltrexone to Methadone Taper

Phase 2

Completed

Conditions: Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders

Interventions: Drug: Placebo comparator
Drug: naltrexone

First Posted Date: 2005-08-26

Last Posted Date: 2017-01-12

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Target Recruit Count: 174

Registration Number: NCT00135759

Locations: 🇺🇸
Duke University, Durham, North Carolina, United States

Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain

Phase 1

Completed

Conditions: Smoking
Nicotine Dependence

Interventions: Drug: Naltrexone
Drug: Bupropion

First Posted Date: 2005-08-11

Last Posted Date: 2020-12-03

Lead Sponsor: Yale University

Target Recruit Count: 40

Registration Number: NCT00129246

Locations: 🇺🇸
Yale University School of Medicine Substance Abuse Treatment Unit, New Haven, Connecticut, United States

Memantine and Naltrexone Treatment for Opioid Dependence

Phase 2

Completed

Conditions: Opioid Dependence

Interventions: Drug: Memantine
Drug: Naltrexone

First Posted Date: 2005-08-01

Last Posted Date: 2018-06-18

Lead Sponsor: New York State Psychiatric Institute

Target Recruit Count: 81

Registration Number: NCT00125515

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

Naltrexone in Borderline Personality Disorder

Phase 3

Terminated

Conditions: Borderline Personality Disorder

Interventions: Drug: Naltrexone

First Posted Date: 2005-07-28

Last Posted Date: 2008-04-15

Lead Sponsor: Central Institute of Mental Health, Mannheim

Target Recruit Count: 48

Registration Number: NCT00124839

Locations: 🇩🇪
Klinik Dr. Schlemmer GmbH, Center for Psychosomatic Medicine, Bad Wiessee, Bavaria, Germany
🇩🇪
Inntalklinik Simbach am Inn, Simbach, Bavaria, Germany
🇩🇪
Dept.of Psychiatry and Psychotherapy; Center of Neurology, Rostock, Mecklenburg-Vorpommern, Germany

and more 2 locations

Trial for the Treatment of Alcohol Dependence

Phase 4

Conditions: Alcoholism

First Posted Date: 2005-07-18

Last Posted Date: 2005-07-18

Lead Sponsor: University of Sydney

Target Recruit Count: 200

Registration Number: NCT00120601

Locations: 🇦🇺
Drug Health Services, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

Managing Alcoholism in People Who Do Not Respond to Naltrexone

Phase 4

Completed

Conditions: Alcoholism

Interventions: Drug: placebo
Drug: Naltrexone
Behavioral: Medication Management (MM)
Behavioral: Telephone Counseling
Behavioral: Combined Behavioral Intervention (CBI)

First Posted Date: 2005-06-21

Last Posted Date: 2019-09-18

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 302

Registration Number: NCT00115037

Locations: 🇺🇸
University of Pennsylvania Treatment Research Center, Chestnut Street, Philadelphia, Pennsylvania, United States

Targeted Interventions for Weight-Concerned Smokers

Phase 2

Completed

Conditions: Nicotine Dependence

Interventions: Drug: Naltrexone
Drug: Transdermal nicotine replacement
Behavioral: Behavioral counseling

First Posted Date: 2005-03-15

Last Posted Date: 2013-03-05

Lead Sponsor: Yale University

Target Recruit Count: 172

Registration Number: NCT00105482

Locations: 🇺🇸
Yale University School of Medicine Substance Abuse Treatment Unit, New Haven, Connecticut, United States

Self-Injury: Diagnosis and Treatment

Phase 3

Conditions: Self-Injurious Behavior
Mental Retardation

First Posted Date: 2003-08-05

Last Posted Date: 2005-06-24

Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Target Recruit Count: 37

Registration Number: NCT00065936

Locations: 🇺🇸
Research Training Institute, Western Carolina Center, Morganton, North Carolina, United States
🇺🇸
Frank Porter Graham Child Development Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

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