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

Endophenotype for Alcohol Misuse in Healthy Minority Populations

Phase 4

Completed

Conditions: Healthy

Interventions: Drug: placebo
Drug: Naltrexone
Other: alcohol
Other: Sham alcohol

First Posted Date: 2005-11-21

Last Posted Date: 2019-08-21

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 43

Registration Number: NCT00256451

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

Naltrexone Effects on Alcohol Intake

Not Applicable

Completed

Conditions: Social Drinker

First Posted Date: 2005-11-16

Last Posted Date: 2023-05-08

Lead Sponsor: University of California, San Francisco

Registration Number: NCT00254670

Locations: 🇺🇸
UCSF, San Francisco, California, United States

Opiate Dependence: Combined Naltrexone/Behavior Therapy - 1

Phase 2

Completed

Conditions: Heroin Dependence

Interventions: Drug: Naltrexone
Behavioral: Compliance Enhancement (CE)
Behavioral: Behavioral Naltrexone Therapy (BNT)

First Posted Date: 2005-10-14

Last Posted Date: 2012-01-13

Lead Sponsor: New York State Psychiatric Institute

Target Recruit Count: 12

Registration Number: NCT00238914

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

Efficacy of Naltrexone Treatment as Augmentation to SSRI in OCD Patients

Not Applicable

Completed

Conditions: Obsessive Compulsive Disorder

First Posted Date: 2005-10-07

Last Posted Date: 2008-01-30

Lead Sponsor: Sheba Medical Center

Registration Number: NCT00234689

Locations: 🇮🇱
Chaim Sheba Medical Center, Ramat-Gan, Israel

Naltrexone Augmentation of Nicotine Patch Therapy - 1

Phase 3

Completed

Conditions: Tobacco Use Disorder

First Posted Date: 2005-09-22

Last Posted Date: 2017-01-12

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Target Recruit Count: 200

Registration Number: NCT00218153

Locations: 🇺🇸
Substance Abuse Treatment Unit, New Haven, Connecticut, United States
🇺🇸
VA Connecticut Health Care System, New Haven, Connecticut, United States

Medications for Stopping Cocaine Dependence and Preventing Relapse

Phase 2

Completed

Conditions: Cocaine Abuse
Cocaine-Related Disorders

Interventions: Drug: Levodopa/Carbidopa
Drug: Modafinil
Drug: Placebo
Drug: Naltrexone HCl
Behavioral: Motivational Interviewing (MI)
Behavioral: Contingency management (CM)
Behavioral: Cognitive-Behavioral Therapy (CBT)

First Posted Date: 2005-09-22

Last Posted Date: 2017-06-09

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

Target Recruit Count: 101

Registration Number: NCT00218023

Locations: 🇺🇸
The University of Texas Health Science Center at Houston, Houston, Texas, United States

Combined Treatment for Cocaine-Alcohol Dependence - 1

Phase 2

Completed

Conditions: Alcohol Dependence
Cocaine Dependence

Interventions: Drug: Placebo
Drug: Naltrexone

First Posted Date: 2005-09-22

Last Posted Date: 2016-01-27

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

Target Recruit Count: 87

Registration Number: NCT00218569

Locations: 🇺🇸
University of Texas Health Sci Cntr Houston, Houston, Texas, United States

Naltrexone in Two Models of Psychosocial Treatments for Cocaine and Alcohol Dependence - 1

Phase 3

Completed

Conditions: Cocaine Dependence
Alcoholism

Interventions: Behavioral: CBT
Drug: Naltrexone
Drug: Placebo
Behavioral: BRENDA

First Posted Date: 2005-09-22

Last Posted Date: 2015-10-22

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 164

Registration Number: NCT00218660

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

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

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