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

Clinical Trials

Glutamate and Opioid Mechanisms of Antidepressant Response to Ketamine

Early Phase 1

Completed

Conditions: Depressive Disorder, Treatment-Resistant

Interventions: Drug: Naltrexone
Drug: Placebo
Drug: Ketamine

First Posted Date: 2021-07-27

Last Posted Date: 2023-03-02

Lead Sponsor: King's College London

Target Recruit Count: 27

Registration Number: NCT04977674

Locations: 🇬🇧
King's College London, London, United Kingdom

Study to Evaluate the Safety of SP-104

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: SP-104
Drug: Naltrexone immediate release oral capsules

First Posted Date: 2021-07-12

Last Posted Date: 2022-01-31

Lead Sponsor: Scilex Pharmaceuticals, Inc.

Target Recruit Count: 52

Registration Number: NCT04958876

Locations: 🇳🇿
Auckland Clinical Studies (NZCR), Auckland, New Zealand
🇳🇿
Christchurch Clinical Studies Trust (NZCR), Christchurch, New Zealand

Naltrexone Neuroimaging

Early Phase 1

Completed

Conditions: Eating Disorders
Binge Eating
Purging (Eating Disorders)

Interventions: Drug: Naltrexone

First Posted Date: 2021-06-23

Last Posted Date: 2023-10-12

Lead Sponsor: Children's Mercy Hospital Kansas City

Target Recruit Count: 13

Registration Number: NCT04935931

Locations: 🇺🇸
Children's Mercy Research Institute, Kansas City, Missouri, United States

Opioid Modulation and Neural Reward Activation in Healthy Adults

Phase 1

Completed

Conditions: Opioid Use, Unspecified
Alcohol Drinking

Interventions: Drug: Naltrexone
Other: Placebo

First Posted Date: 2021-04-22

Last Posted Date: 2023-11-28

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 13

Registration Number: NCT04854551

Locations: 🇺🇸
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections

Phase 1

Completed

Conditions: Opioid-use Disorder

Interventions: Drug: BICX104
Drug: Vivitrol

First Posted Date: 2021-04-02

Last Posted Date: 2023-08-16

Lead Sponsor: BioCorRx Inc

Target Recruit Count: 24

Registration Number: NCT04828694

Locations: 🇺🇸
Orange County Research Center, Tustin, California, United States

Intermittent Oral Naltrexone Enhanced With an Ecological Momentary Intervention for Methamphetamine-using MSM

Phase 2

Active, not recruiting

Conditions: Methamphetamine Use Disorder

Interventions: Drug: Naltrexone Hydrochloride
Drug: Placebo
Behavioral: Ecological Momentary Intervention

First Posted Date: 2021-03-10

Last Posted Date: 2024-02-20

Lead Sponsor: Glenn-Milo Santos

Target Recruit Count: 54

Registration Number: NCT04791969

Locations: 🇺🇸
San Francisco Department of Public Health, San Francisco, California, United States

Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients

Phase 3

Active, not recruiting

Conditions: Charcot-Marie-Tooth Disease

Interventions: Drug: (RS)-baclofen, naltrexone hydrochloride and D-sorbitol
Drug: Placebo

First Posted Date: 2021-02-21

Last Posted Date: 2024-04-03

Lead Sponsor: Pharnext S.C.A.

Target Recruit Count: 350

Registration Number: NCT04762758

Locations: 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Hackensack Meridian Health Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
Massachusetts General Hospital Neuromuscular Diagnostic Center, Boston, Massachusetts, United States

and more 47 locations

An Investigation of the Effects of Opioid Receptor Blockade on Changes in Self-esteem and Social Attention

Not Applicable

Completed

Conditions: Self Esteem

Interventions: Drug: Placebo
Drug: Naltrexone

First Posted Date: 2021-02-17

Last Posted Date: 2021-02-18

Lead Sponsor: McGill University

Target Recruit Count: 35

Registration Number: NCT04757506

Impact of Colchicine and Low-dose Naltrexone on COVID-19

Phase 2

Completed

Conditions: Covid19

Interventions: Drug: Colchicine 0.6 mg
Drug: Naltrexone

First Posted Date: 2021-02-16

Last Posted Date: 2023-07-25

Lead Sponsor: HealthPartners Institute

Target Recruit Count: 142

Registration Number: NCT04756128

Locations: 🇺🇸
Regions Hospital, Saint Paul, Minnesota, United States
🇺🇸
Park Nicollet Methodist Hospital, Saint Louis Park, Minnesota, United States

Cost-utility and Physiological Effects of LDN in Patients With Fibromyalgia

Phase 4

Active, not recruiting

Conditions: Randomized Controlled Trial

Interventions: Drug: Low-dose naltrexone

First Posted Date: 2021-02-05

Last Posted Date: 2024-04-22

Lead Sponsor: Fundació Sant Joan de Déu

Target Recruit Count: 99

Registration Number: NCT04739995

Locations: 🇪🇸
Parc Sanitari Sant Joan de Déu (PSSJD), Sant Boi De Llobregat, Barcelona, Spain

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