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

Medication Development in Alcoholism: Acamprosate Versus Naltrexone

Phase 2

Completed

Conditions: Alcoholism

Interventions: Drug: Placebo
Drug: Acamprosate
Drug: Naltrexone

First Posted Date: 2008-04-11

Last Posted Date: 2017-03-29

Lead Sponsor: The Scripps Research Institute

Target Recruit Count: 68

Registration Number: NCT00656630

Locations: 🇺🇸
The Scripps Research Institute, La Jolla, California, United States

Naltrexone for Heavy Drinking in Young Adults

Phase 4

Completed

Conditions: Alcohol Consumption
Alcoholic Intoxication
Alcohol-induced Disorders
Alcoholism

Interventions: Behavioral: BASICS counseling
Drug: naltrexone
Drug: placebo naltrexone

First Posted Date: 2007-12-06

Last Posted Date: 2020-03-30

Lead Sponsor: Yale University

Target Recruit Count: 140

Registration Number: NCT00568958

Locations: 🇺🇸
Connecticut Mental Health Center - Substance Abuse Treatment Unit, New Haven, Connecticut, United States

Augmenting Zyprexa With Naltrexone to Ameliorate Metabolic Side-Effects

Phase 1

Completed

Conditions: Schizophrenia
Psychotic Disorders

Interventions: Drug: placebo
Drug: naltrexone

First Posted Date: 2007-12-04

Last Posted Date: 2013-10-25

Lead Sponsor: Mclean Hospital

Target Recruit Count: 30

Registration Number: NCT00567034

Locations: 🇺🇸
McLean Hospital, Belmont, Massachusetts, United States

Research on Individualized Treatment for Alcoholism

Phase 2

Completed

Conditions: Alcohol Dependence

First Posted Date: 2007-08-31

Last Posted Date: 2007-08-31

Lead Sponsor: Indiana University School of Medicine

Target Recruit Count: 185

Registration Number: NCT00523133

Locations: 🇺🇸
University Hospital, Psychiatry Outpatient Clinic, Indianapolis, Indiana, United States

Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers

Phase 1

Completed

Conditions: Nicotine Dependence
Smoking

Interventions: Drug: Naltrexone
Drug: Varenicline

First Posted Date: 2007-07-17

Last Posted Date: 2018-01-17

Lead Sponsor: Yale University

Target Recruit Count: 40

Registration Number: NCT00502216

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

A Randomized Placebo-Controlled, Crossover-Design Study of the Effects of Low Dose Naltrexone

Phase 3

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: 4.5 mg Naltrexone
Drug: Naltrexone

First Posted Date: 2007-07-16

Last Posted Date: 2008-05-19

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 80

Registration Number: NCT00501696

Locations: 🇺🇸
MS Center UCSF, Parnassus Ave, suite #908, SAn Francisco, California, United States

Memantine as a Supplement to Naltrexone in Treating Heroin Dependence

Phase 2

Completed

Conditions: Heroin Dependence
Opioid Dependence

Interventions: Drug: Vivitrol
Drug: memantine

First Posted Date: 2007-05-21

Last Posted Date: 2018-07-17

Lead Sponsor: New York State Psychiatric Institute

Target Recruit Count: 82

Registration Number: NCT00476242

Locations: 🇺🇸
STARS, New York, New York, United States

Double-Blind Naltrexone in Compulsive Sexual Behavior

Phase 2

Completed

Conditions: Compulsive Sexual Behavior

Interventions: Drug: Naltrexone
Drug: Sugar pill

First Posted Date: 2007-04-30

Last Posted Date: 2012-05-18

Lead Sponsor: University of Minnesota

Target Recruit Count: 7

Registration Number: NCT00467558

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

Naltrexone in the Treatment of Pyromania

Phase 2

Withdrawn

Conditions: Pyromania

Interventions: Drug: Naltrexone
Drug: Placebo

First Posted Date: 2007-04-30

Last Posted Date: 2011-12-14

Lead Sponsor: University of Minnesota

Registration Number: NCT00467454

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

Medication and Counseling for Controlled Drinking (Project SMART)

Phase 3

Completed

Conditions: Alcohol-related Disorders
Alcohol Drinking
Alcoholism
Alcohol Abuse

Interventions: Drug: Naltrexone
Behavioral: Modified Behavioral Self-Control Psychotherapy
Behavioral: Brief Behavioral Compliance Enhancement Therapy

First Posted Date: 2007-03-07

Last Posted Date: 2013-05-01

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

Target Recruit Count: 200

Registration Number: NCT00444418

Locations: 🇺🇸
Research Foundation for Mental Hygiene, Columbia Addiction Services and Psychotherapy Intervention Research, 3 Columbus Circle, Suite 1404, New York, New York, United States

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