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

The Separate and Combined Effects of Vivitrol and Opiate Abstinence Reinforcement in the Treatment of Opioid Dependence

Phase 2

Completed

Conditions: Opioid Dependence

Interventions: Other: Usual Care Control
Drug: Vivitrol
Behavioral: Employment-based opiate abstinence reinforcement

First Posted Date: 2012-03-16

Last Posted Date: 2018-03-12

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 84

Registration Number: NCT01556425

Locations: 🇺🇸
Johns Hopkins Bayview Center for Learning and Health, Baltimore, Maryland, United States

Depot Naltrexone Mechanism of Action in Heroin Dependent Patients Using fMRI and SPECT

Phase 4

Completed

Conditions: Heroin Dependence
Opioid-Related Disorders

Interventions: Drug: Naltrexone

First Posted Date: 2011-11-15

Last Posted Date: 2014-10-13

Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Target Recruit Count: 40

Registration Number: NCT01471145

Locations: 🇳🇱
Academic Medical Center, Amsterdam, Netherlands

Extended-Release Naltrexone to Treat Methamphetamine Dependence in Men Who Have Sex With Men (MSM)

Phase 2

Completed

Conditions: Amphetamine-Related Disorders

Interventions: Drug: Naltrexone
Drug: Placebo

First Posted Date: 2011-10-10

Last Posted Date: 2016-04-13

Lead Sponsor: San Francisco Department of Public Health

Target Recruit Count: 100

Registration Number: NCT01449565

Locations: 🇺🇸
Substance Use Research Unit, San Francisco, California, United States

Naltrexone and Behavioral Drug and HIV Risk Reduction Counseling in Russia

Phase 3

Completed

Conditions: Opiate Dependence

Interventions: Drug: Naltrexone (oral)
Drug: Vivitrol
Behavioral: Medical Management
Behavioral: BDRC

First Posted Date: 2011-07-07

Last Posted Date: 2018-01-11

Lead Sponsor: Yale University

Target Recruit Count: 320

Registration Number: NCT01389167

Locations: 🇷🇺
Pavlov University, St. Petersburg, Russian Federation

Improved Strategies for Outpatient Opioid Detoxification

Phase 1

Completed

Conditions: Opioid Dependence

Interventions: Drug: oral naltrexone
Drug: Buprenorphine
Drug: Vivitrol

First Posted Date: 2011-06-21

Last Posted Date: 2018-05-21

Lead Sponsor: New York State Psychiatric Institute

Target Recruit Count: 150

Registration Number: NCT01377610

Locations: 🇺🇸
Substance Treatment and Research Service (STARS), Columbia University, New York, New York, United States

Treatment Strategy for Alcohol Use Disorders in Veterans With TBI

Phase 3

Completed

Conditions: Alcohol Dependence

Interventions: Drug: Valproate
Drug: Naltrexone

First Posted Date: 2011-04-27

Last Posted Date: 2016-06-09

Lead Sponsor: VA Office of Research and Development

Target Recruit Count: 62

Registration Number: NCT01342549

Locations: 🇺🇸
Iowa City VA Health Care System, Iowa City, IA, Iowa City, Iowa, United States
🇺🇸
Michael E. DeBakey VA Medical Center, Houston, TX, Houston, Texas, United States

Role of the Endogenous Opioid System Underlying Modulation of Experimental Pain

Not Applicable

Withdrawn

Conditions: Temporomandibular Disorder
Facial Pain

Interventions: Drug: Naltrexone
Drug: Placebo

First Posted Date: 2011-04-01

Last Posted Date: 2012-07-13

Lead Sponsor: University of Florida

Registration Number: NCT01327326

Sweet Preference and Alcohol Craving

Phase 2

Completed

Conditions: Alcohol Abuse
Alcohol Dependence

Interventions: Drug: Naltrexone
Behavioral: Brenda Therapy Sessions
Drug: Placebo

First Posted Date: 2011-02-15

Last Posted Date: 2013-11-25

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 80

Registration Number: NCT01296646

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

Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

Phase 2

Completed

Conditions: Reduction in Heavy Drinking in Patients With HIV

Interventions: Drug: Naltrexone
Other: Placebo + Medication Management/Medication Coaching

First Posted Date: 2010-10-22

Last Posted Date: 2019-03-21

Lead Sponsor: Yale University

Target Recruit Count: 51

Registration Number: NCT01227044

Locations: 🇺🇸
Yale University School of Medicine, New Haven, Connecticut, United States
🇺🇸
VACT Healthcare System, New Haven, Connecticut, United States

Effects of Omegas 3 and 6 on Alcohol Dependence

Phase 3

Completed

Conditions: Alcohol Dependence

Interventions: Drug: PUFAs
Drug: Placebo
Drug: Naltrexone + Placebo
Drug: Naltrexone

First Posted Date: 2010-09-29

Last Posted Date: 2010-09-29

Lead Sponsor: Federal University of São Paulo

Target Recruit Count: 80

Registration Number: NCT01211769

Locations: 🇧🇷
Universidade Federal de São Paulo, São Paulo, Brazil

Drug Development Updates

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