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

Naltrexone for Bipolar Disorder and Alcohol Dependence

Phase 4

Completed

Conditions: Alcohol Dependence
Bipolar Disorder

First Posted Date: 2005-09-22

Last Posted Date: 2011-05-24

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 50

Registration Number: NCT00223275

Locations: 🇺🇸
UTSouthwestern Medical Center, Dallas, Texas, United States

Naltrexone Implants vs. MMT Among Inmates in the Norwegian Correctional Services

Phase 2

Completed

Conditions: Opiate Addiction

Interventions: Drug: Naltrexone
Drug: Methadone

First Posted Date: 2005-09-20

Last Posted Date: 2011-05-19

Lead Sponsor: University of Oslo

Target Recruit Count: 46

Registration Number: NCT00204243

Locations: 🇳🇴
Unit for Addiction Medicine, Oslo, Norway

Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone

Phase 3

Completed

Conditions: Alcohol Dependence

Interventions: Drug: Naltrexone plus Gabapentin
Other: Inactive Placebo
Drug: Naltrexone

First Posted Date: 2005-09-16

Last Posted Date: 2018-06-07

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 150

Registration Number: NCT00183196

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

Effectiveness of Naltrexone and/or Ondansetron to Reduce Craving for Alcohol and Drinking

Phase 2

Completed

Conditions: Alcohol Dependence

First Posted Date: 2005-09-16

Last Posted Date: 2010-05-05

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 160

Registration Number: NCT00183222

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

Science-Based Treatment for Opioid-Dependent Adolescents

Phase 2

Conditions: Opioid-Dependence Among Adolescents

First Posted Date: 2005-09-16

Last Posted Date: 2008-08-12

Lead Sponsor: National Development and Research Institutes, Inc.

Target Recruit Count: 80

Registration Number: NCT00182572

Locations: 🇺🇸
Behavioral Science Research Unit, St. Luke's Hospital, New York, New York, United States

Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence

Phase 3

Completed

Conditions: Cocaine Dependence
Alcoholism

Interventions: Drug: Naltrexone

First Posted Date: 2005-09-14

Last Posted Date: 2018-02-28

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 164

Registration Number: NCT00167232

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

ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults

Phase 3

Completed

Conditions: Alcoholism

Interventions: Drug: Medisorb naltrexone 190 mg
Drug: Medisorb naltrexone 380 mg

First Posted Date: 2005-09-12

Last Posted Date: 2017-07-11

Lead Sponsor: Alkermes, Inc.

Target Recruit Count: 108

Registration Number: NCT00156923

ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])

Phase 3

Terminated

Conditions: Alcoholism
Opiate Dependence

Interventions: Drug: Medisorb naltrexone 380 mg
Drug: Oral naltrexone to Medisorb naltrexone 380 mg

First Posted Date: 2005-09-12

Last Posted Date: 2010-11-17

Lead Sponsor: Alkermes, Inc.

Target Recruit Count: 108

Registration Number: NCT00156936

Naltrexone Treatment of Alcohol Abuse in Schizophrenia

Phase 4

Completed

Conditions: Schizophrenia
Mental Disorders
Alcohol Abuse
Alcoholism
Alcohol-related Disorders

Interventions: Drug: Naltrexone or Placebo

First Posted Date: 2005-09-05

Last Posted Date: 2013-01-08

Lead Sponsor: State University of New York - Upstate Medical University

Target Recruit Count: 90

Registration Number: NCT00145847

Locations: 🇺🇸
St. Joseph's Mental Health Services, Syracuse, New York, United States
🇺🇸
Hutchings Psychiatric Center, Syracuse, New York, United States
🇺🇸
SUNY Upstate Medical University, Syracuse, New York, United States

and more 1 locations

Naltrexone and Adrenergic Agents to Reduce Heroin Use in Heroin Addicts

Phase 2

Completed

Conditions: Heroin Dependence

Interventions: Drug: Naltrexone
Drug: Placebo

First Posted Date: 2005-09-02

Last Posted Date: 2012-10-24

Lead Sponsor: Baylor College of Medicine

Target Recruit Count: 301

Registration Number: NCT00142948

Locations: 🇷🇺
Saint Petersburg Pavlov State Medical University, Saint Petersburg, Russian Federation

Drug Development Updates

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