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

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

Effects of Yohimbine and Naltrexone on Sexual Function

Completed

Conditions: Erectile Dysfunction

First Posted Date: 2002-08-01

Last Posted Date: 2008-03-04

Lead Sponsor: National Institute of Mental Health (NIMH)

Target Recruit Count: 40

Registration Number: NCT00042536

Locations: 🇺🇸
National Institute of Mental Health (NIMH), Bethesda, Maryland, United States

Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)

Phase 2

Completed

Conditions: Alcoholism

First Posted Date: 2001-11-21

Last Posted Date: 2007-12-10

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

Target Recruit Count: 360

Registration Number: NCT00027079

Locations: 🇺🇸
University of Texas Health Science Center, San Antonio, Texas, United States

Naltrexone and Patch for Smokers

Not Applicable

Completed

Conditions: Smoking

First Posted Date: 2001-07-05

Last Posted Date: 2009-01-21

Lead Sponsor: US Department of Veterans Affairs

Registration Number: NCT00018213

Locations: 🇺🇸
VA Medical Center, Providence, Rhode Island, 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

Post-Treatment Effects of Naltrexone

Phase 4

Completed

Conditions: Alcoholism

First Posted Date: 2000-11-07

Last Posted Date: 2010-05-12

Lead Sponsor: Indiana University

Target Recruit Count: 160

Registration Number: NCT00006449

Locations: 🇺🇸
Institute of Psychiatric Research, Indiana University School of Medicine, Indianapolis, Indiana, 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, Craving, and Drinking

Phase 4

Completed

Conditions: Alcoholism

First Posted Date: 2000-09-12

Last Posted Date: 2006-10-23

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

Target Recruit Count: 186

Registration Number: NCT00006203

Locations: 🇺🇸
Center for Alcohol and Addiction Studies, Brown University, Providence, Rhode Island, United States

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