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

Validation of a Test System for Development of Medications for Alcoholism

Phase 3

Completed

Conditions: Alcoholism

Interventions: Drug: Placebo
Drug: Naltrexone

First Posted Date: 2016-01-12

Last Posted Date: 2017-09-27

Lead Sponsor: Technische Universität Dresden

Target Recruit Count: 46

Registration Number: NCT02652585

Locations: 🇩🇪
Klinik und Poliklinik für Psychiatrie und Psychotherapie, Dresden, Germany

Medication-Assisted Treatment for Youth With Substance Use Disorders

Phase 1

Completed

Conditions: Opioid Use Disorder
Opioid Dependence

Interventions: Drug: Naltrexone

First Posted Date: 2015-11-01

Last Posted Date: 2018-10-31

Lead Sponsor: New York State Psychiatric Institute

Target Recruit Count: 11

Registration Number: NCT02593474

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

Dopamine and Opioid Receptor Antagonists Reduce Cue-induced Reward Responding and Reward Impulsivity

Not Applicable

Completed

Conditions: Addiction

Interventions: Drug: Placebo
Drug: Amisulpride
Drug: Naltrexone

First Posted Date: 2015-09-23

Last Posted Date: 2015-09-23

Lead Sponsor: University of Zurich

Target Recruit Count: 121

Registration Number: NCT02557984

Locations: 🇨🇭
University Hospital, Zurich, Switzerland

The Effect of Regular Naltrexone Dosing on Disordered Gamblers

Phase 1

Completed

Conditions: Gambling

Interventions: Drug: Naltrexone

First Posted Date: 2015-09-01

Last Posted Date: 2022-06-01

Lead Sponsor: University of Calgary

Target Recruit Count: 35

Registration Number: NCT02537197

Locations: 🇨🇦
Opioid Dependency Program, Calgary, Alberta, Canada

The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism

Not Applicable

Completed

Conditions: Opiate Addiction

Interventions: Drug: Naltrexone
Drug: Clonidine
Drug: Lorazepam

First Posted Date: 2015-02-12

Last Posted Date: 2015-02-12

Lead Sponsor: Vilnius University

Target Recruit Count: 60

Registration Number: NCT02362256

Locations: 🇱🇹
Republic Vilnius University Hospital, Vilnius, Lithuania

Say When: Targeting Heavy Alcohol Use With Naltrexone Among MSM

Phase 2

Completed

Conditions: Binge Drinking
HIV

Interventions: Drug: Placebo
Drug: Naltrexone

First Posted Date: 2015-01-05

Last Posted Date: 2021-09-28

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 120

Registration Number: NCT02330419

Locations: 🇺🇸
Center on Substance Use and Health, San Francisco, California, United States

Biomarkers of Injectable Extended Release Naltrexone Treatment

Phase 4

Completed

Conditions: Heroin Dependence
Opioid Dependence

Interventions: Drug: Naltrexone

First Posted Date: 2014-12-24

Last Posted Date: 2023-01-12

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 32

Registration Number: NCT02324725

Locations: 🇺🇸
Center for the Studies of Addiction, Philadelphia, Pennsylvania, United States

Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders

Phase 2

Completed

Conditions: Alcohol Use Disorder
Posttraumatic Stress Disorder (PTSD)

Interventions: Drug: Prazosin
Drug: Placebo (Naltrexone)
Drug: Placebo (Prazosin)
Drug: Naltrexone

First Posted Date: 2014-12-22

Last Posted Date: 2020-12-29

Lead Sponsor: Seattle Institute for Biomedical and Clinical Research

Target Recruit Count: 31

Registration Number: NCT02322047

Locations: 🇺🇸
VA Puget Sound Healthcare System, Seattle, Washington, United States

Treatment of Chronic Itch in Atopic Dermatitis (Eczema): Nerve Function

Phase 1

Completed

Conditions: Cutaneous Nerves CNS Itch

Interventions: Drug: Clonidine
Drug: Naltrexone

First Posted Date: 2014-10-20

Last Posted Date: 2023-01-26

Lead Sponsor: University of Minnesota

Target Recruit Count: 8

Registration Number: NCT02268448

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

Trial of Naltrexone and Dextromethorphan for Gulf War Illness

Phase 2

Completed

Conditions: Gulf War Illness

Interventions: Drug: naltrexone
Drug: Dextromethorphan

First Posted Date: 2014-08-01

Last Posted Date: 2016-03-03

Lead Sponsor: East Carolina University

Target Recruit Count: 60

Registration Number: NCT02206490

Locations: 🇺🇸
Brody School of Medicine a East Carolina Univesity, Greenville, North Carolina, United States

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