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

Double-Blind Trial of Ketamine Therapy Plus or Minus Naltrexone in Treatment Resistant Depression (TRD)

Phase 1

Completed

Conditions: Depression

Interventions: Drug: Naltrexone

First Posted Date: 2016-09-22

Last Posted Date: 2018-04-24

Lead Sponsor: Stanford University

Target Recruit Count: 16

Registration Number: NCT02911597

Locations: 🇺🇸
Stanford University, Stanford, California, United States

Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home

Phase 1

Completed

Conditions: Alcohol-Related Disorders
Alcohol Drinking
Alcohol Abuse
Alcoholism
Alcohol Use Disorders

Interventions: Behavioral: Motivation Enhancement Therapy
Behavioral: Modified Behavioral Self-Control Therapy
Other: Referral to specialty substance use disorder treatment
Drug: Naltrexone
Behavioral: Brief Advice

First Posted Date: 2016-08-31

Last Posted Date: 2023-10-30

Lead Sponsor: Northwell Health

Target Recruit Count: 27

Registration Number: NCT02885311

Locations: 🇺🇸
Northwell Health, Great Neck, New York, United States

An Open Label Trial of Bupropion and Naltrexone for Binge Drinking

Phase 2

Completed

Conditions: Binge Drinking

Interventions: Drug: Naltrexone
Drug: Bupropion

First Posted Date: 2016-07-22

Last Posted Date: 2018-12-26

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 12

Registration Number: NCT02842073

Locations: 🇺🇸
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

An fMRI Study of Opioid-related Changes in Neural Activity

Not Applicable

Completed

Conditions: Social Acceptance

Interventions: Drug: Naltrexone
Drug: Placebo

First Posted Date: 2016-06-29

Last Posted Date: 2019-07-23

Lead Sponsor: Tristen Inagaki

Target Recruit Count: 82

Registration Number: NCT02818036

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

The Impact of the Opiate Antagonist Naltrexone on the Emotional Valence of Dreams

Phase 4

Completed

Conditions: Neuroscience of Dreaming, Healthy

Interventions: Other: Placebo
Drug: Naltrexone

First Posted Date: 2016-06-07

Last Posted Date: 2017-04-05

Lead Sponsor: University of Bern

Target Recruit Count: 32

Registration Number: NCT02792140

Locations: 🇨🇭
University of Bern, Bern, Switzerland

Pharmacokinetic Evaluation of Intranasal, Intramuscular, and Oral Naltrexone in Healthy Volunteers

Phase 1

Completed

Conditions: Opioid-Related Disorders

Interventions: Drug: Naltrexone
Other: Intravail

First Posted Date: 2016-04-25

Last Posted Date: 2017-01-12

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Target Recruit Count: 14

Registration Number: NCT02750748

Locations: 🇺🇸
Vince and Associates Clinical Research, Inc., Overland Park, Kansas, United States

Naltrexone and Bupropion Combination on Obese,Smoking Patients With Schizophrenia

Phase 4

Completed

Conditions: Obese
Cigarette-smoking
Schizophrenia

Interventions: Drug: Placebo Naltrexone
Drug: Naltrexone
Drug: Placebo Bupropion
Drug: Bupropion

First Posted Date: 2016-04-13

Last Posted Date: 2021-10-22

Lead Sponsor: Shanghai Mental Health Center

Target Recruit Count: 22

Registration Number: NCT02736474

Evaluation of Naltrexone as a Treatment for Self-injurious Behavior

Phase 4

Withdrawn

Conditions: Self-injurious Behavior
Self Mutilation

Interventions: Drug: Naltrexone
Other: Placebo

First Posted Date: 2016-04-01

Last Posted Date: 2017-11-06

Lead Sponsor: Western Michigan University School of Medicine

Registration Number: NCT02726035

Locations: 🇺🇸
Borgess Research Institute, Kalamazoo, Michigan, United States

Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL

Phase 3

Completed

Conditions: Opioid Use Disorder

Interventions: Drug: Placebo
Drug: Naltrexone
Drug: Buprenorphine

First Posted Date: 2016-03-02

Last Posted Date: 2019-02-12

Lead Sponsor: Alkermes, Inc.

Target Recruit Count: 101

Registration Number: NCT02696434

Locations: 🇺🇸
John Hopkins School of Medicine, Baltimore, Maryland, United States
🇺🇸
Neuroscience Research Institute, Inc., Winfield, Illinois, United States
🇺🇸
Segal Institute for Clinical Research, Lauderhill, Florida, United States

and more 6 locations

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

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