Nalmefene

Generic Name: Nalmefene

Brand Names: Opvee, Revex, Selincro

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₅NO_₃

CAS Number: 55096-26-9

Unique Ingredient Identifier: TOV02TDP9I

Background: Nalmefene, a 6-methylene analogue of naltrexone, is an opioid receptor antagonist. It acts as an antagonist at the mu (μ)-opioid and delta (δ)-opioid receptors and a partial agonist at the kappa (κ)-opioid receptor.
...

Indication: Nalmefene oral tablet is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification. Nalmefene should only be prescribed in conjunction with continuous psychosocial support focused on treatment adhe...

Associated Conditions: Alcohol Dependency, Opioid Overdose

Associated Therapies: -

Clinical Trials

TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis

Phase 2

Not yet recruiting

Conditions: Pruritus
Primary Biliary Cholangitis

Interventions: Drug: Nalmefene
Drug: Placebo

First Posted Date: 2024-12-13

Last Posted Date: 2024-12-17

Lead Sponsor: Tharimmune Inc

Target Recruit Count: 40

Registration Number: NCT06733519

An Evaluation of The Absolute Bioavailability of TH104

Phase 1

Active, not recruiting

Conditions: Healthy

Interventions: Drug: Nalmefene

First Posted Date: 2024-01-10

Last Posted Date: 2024-02-13

Lead Sponsor: Tharimmune Inc

Target Recruit Count: 20

Registration Number: NCT06198686

Locations: 🇺🇸
Novum Pharmaceutical Research Services, Las Vegas, Nevada, United States

NAlmefene Versus Placebo in Addition to Treatment as Usual on Craving in Behavioural Addictions

Phase 3

Recruiting

Conditions: Behavioural Addiction

Interventions: Drug: Nalmefene
Drug: Placebo

First Posted Date: 2022-09-14

Last Posted Date: 2023-11-09

Lead Sponsor: Nantes University Hospital

Target Recruit Count: 266

Registration Number: NCT05540288

Locations: 🇫🇷
CHU de Besançon, Besançon, France
🇫🇷
CHU de Clermont Ferrand, Clermont-Ferrand, France
🇫🇷
CH de La Rochelle, La Rochelle, France

and more 8 locations

Pharmacokinetic Evaluation of Intranasal Nalmefene

Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: Nalmefene Hydrochloride
Drug: Nalmefene

First Posted Date: 2021-02-18

Last Posted Date: 2024-08-13

Lead Sponsor: Opiant Pharmaceuticals Inc

Target Recruit Count: 68

Registration Number: NCT04759768

Locations: 🇺🇸
Worldwide Clinical Trials, San Antonio, Texas, United States

Effect of Nalmefene on the Quality of Resuscitation in Patients Under General Anesthesia

Phase 4

Recruiting

Conditions: Resuscitation

Interventions: Drug: normal Saline
Drug: Nalmefene

First Posted Date: 2021-01-19

Last Posted Date: 2022-10-06

Lead Sponsor: RenJi Hospital

Target Recruit Count: 520

Registration Number: NCT04713358

Locations: 🇨🇳
The First Affiliated Hospital of Guangxi Medical University, Guangxi, Guangxi, China
🇨🇳
Renji Hospital, Shanghai, Shanghai, China
🇨🇳
Shanghai Tong Ren Hospital, Shanghai, Shanghai, China

and more 1 locations

Patient Driven Recovery With Nalmefene and Coaching

Phase 1

Completed

Conditions: Harmful; Use, Alcohol
Opioid-use Disorder

Interventions: Drug: Nalmefene

First Posted Date: 2017-09-12

Last Posted Date: 2021-01-22

Lead Sponsor: Yale University

Target Recruit Count: 10

Registration Number: NCT03279562

Locations: 🇺🇸
Yale University, Department, New Haven, Connecticut, United States

St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene

Phase 1

Completed

Conditions: HIV Infection
Alcohol Use
Pain

Interventions: Drug: Low dose naltrexone
Drug: Nalmefene

First Posted Date: 2017-09-12

Last Posted Date: 2020-08-24

Lead Sponsor: Boston Medical Center

Target Recruit Count: 11

Registration Number: NCT03278886

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

Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers

Phase 1

Completed

Conditions: Opioid-Related Disorders

Interventions: Drug: Nalmefene

First Posted Date: 2017-04-26

Last Posted Date: 2018-03-26

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Target Recruit Count: 14

Registration Number: NCT03129347

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

Effect of Dexmedetomidine Combined With Low-dose Nalmefene on Preventing Remifentanil-induced Postoperative Hyperalgesia

Not Applicable

Completed

Conditions: Pain
Anesthesia

Interventions: Drug: Normal saline
Drug: Remifentanil
Drug: Dexmedetomidine injection
Drug: Sufentanil
Drug: Nalmefene

First Posted Date: 2017-03-30

Last Posted Date: 2021-08-03

Lead Sponsor: Tianjin Medical University General Hospital

Target Recruit Count: 150

Registration Number: NCT03096730

Locations: 🇨🇳
Tianjin Medical University General Hospital, Tianjin, Tianjin, China

Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects

Phase 2

Completed

Conditions: Alcohol Use Disorder

Interventions: Drug: Nalmefene
Drug: Baclofen
Drug: Placebo Oral Capsule

First Posted Date: 2017-01-27

Last Posted Date: 2020-10-29

Lead Sponsor: Prof. Daniele Zullino

Target Recruit Count: 37

Registration Number: NCT03034408

Locations: 🇨🇭
Service d'Addictologie, Hôpitaux Universitaires de Genève, Geneva, Switzerland

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