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

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

Drug Treatment for Pathologic Gambling Disorder

Phase 3

Completed

Conditions: Gambling

Interventions: Drug: Placebo
Drug: Naltrexone

First Posted Date: 2003-02-05

Last Posted Date: 2023-02-23

Lead Sponsor: University of Chicago

Target Recruit Count: 83

Registration Number: NCT00053677

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

Treating Alcohol Use In Older Adults With Depression

Phase 4

Completed

Conditions: Alcoholism
Depression

Interventions: Drug: Placebo
Drug: NALTREXONE

First Posted Date: 2001-07-05

Last Posted Date: 2009-09-23

Lead Sponsor: US Department of Veterans Affairs

Target Recruit Count: 74

Registration Number: NCT00018824

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

Naltrexone in Treatment of Cocaine Dependence - 5

Phase 2

Completed

Conditions: Cocaine-Related Disorders

First Posted Date: 2001-04-18

Last Posted Date: 2017-01-16

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Registration Number: NCT00015080

Locations: 🇺🇸
Cincinnati MDRU, Cincinnati, Ohio, United States

Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)

Phase 4

Completed

Conditions: Alcoholism
Alcohol Dependence
Post-Traumatic Stress Disorder

Interventions: Drug: Naltrexone
Behavioral: Cognitive-Behavioral Therapy
Drug: Placebo

First Posted Date: 2000-11-09

Last Posted Date: 2017-04-21

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 165

Registration Number: NCT00006489

Locations: 🇺🇸
Center for Anxiety, University of Pennsylvania, Philadelphia, Pennsylvania, United States

COMBINE (Acamprosate/Naltrexone)

Phase 3

Completed

Conditions: Alcoholism

First Posted Date: 2000-09-12

Last Posted Date: 2010-05-03

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 1375

Registration Number: NCT00006206

Locations: 🇺🇸
Harvard University/McLean Hospital, Belmont, Massachusetts, United States
🇺🇸
University of Wisconsin-Milwaukee, Milwaukee, Wisconsin, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

and more 9 locations

Naltrexone for Early Problem Drinkers

Phase 4

Completed

Conditions: Alcoholism

First Posted Date: 1999-11-03

Last Posted Date: 2011-06-20

Lead Sponsor: UConn Health

Target Recruit Count: 160

Registration Number: NCT00000455

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

Drug Development Updates

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

Home Terms & Conditions Privacy Policy