Nalmefene

Generic Name
Nalmefene
Brand Names
Opvee, Revex, Selincro
Drug Type
Small Molecule
Chemical Formula
C21H25NO3
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
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Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study

First Posted Date
2016-10-17
Last Posted Date
2016-10-17
Lead Sponsor
University Hospital, Clermont-Ferrand
Target Recruit Count
30
Registration Number
NCT02934919
Locations
🇫🇷

CHU Clermont-Ferrand, Clermont-ferrand, France

Nalmefene in Alcohol Dependence and Borderline Personality Disorder

First Posted Date
2016-04-27
Last Posted Date
2016-04-27
Lead Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Target Recruit Count
30
Registration Number
NCT02752503
Locations
🇪🇸

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

Title: Effect of Opioid Receptor Modulation on Alcohol Self-Administration and Neural Response to Alcohol Cues in Heavy Drinkers: Role of OPRM1 Gene Variation

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-12-24
Last Posted Date
2024-11-14
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Target Recruit Count
13
Registration Number
NCT02639273
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Use of Selincro and Impact on Usual Practice

Completed
Conditions
First Posted Date
2015-07-08
Last Posted Date
2018-05-14
Lead Sponsor
University of Bordeaux
Target Recruit Count
700
Registration Number
NCT02492581
Locations
🇫🇷

University of Bordeaux, Bordeaux, France

Single-dose of Nalmefene to Modulate Neural Alcohol Cue Reactivity

Early Phase 1
Terminated
Conditions
Interventions
First Posted Date
2015-02-26
Last Posted Date
2017-07-02
Lead Sponsor
Central Institute of Mental Health, Mannheim
Target Recruit Count
23
Registration Number
NCT02372318
Locations
🇩🇪

Zentralinstitut für Seelische Gesundheit, Mannheim, Germany

Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use

Phase 4
Completed
Conditions
Interventions
First Posted Date
2014-07-22
Last Posted Date
2016-12-14
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
45
Registration Number
NCT02197598
Locations
🇩🇪

DE001, Heidelberg, Germany

🇩🇪

Optuminisight, München, Germany

🇩🇪

DE002, Mannheim, Germany

Efficacy of Nalmefene in Patients With Alcohol Dependence

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-12-22
Last Posted Date
2013-07-22
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
678
Registration Number
NCT00812461
Locations
🇫🇷

FR009, Clichy Cedex 92, France

🇪🇸

ES004, Barcelona, Spain

🇪🇸

ES002, Oviedo, Spain

and more 54 locations

Efficacy of Nalmefene in Patients With Alcohol Dependence

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-12-19
Last Posted Date
2013-07-09
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
598
Registration Number
NCT00811720
Locations
🇦🇹

AT004, Salzburg, Austria

🇫🇮

FI008, Helsinki, Finland

🇩🇪

DE006, Hamburg, Germany

and more 35 locations

Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-12-19
Last Posted Date
2013-08-07
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
665
Registration Number
NCT00811941
Locations
🇺🇦

UA010, Ternopil, Ukraine

🇨🇿

CZ001, Usti nad Labem, Czech Republic

🇵🇱

PL011, Krakow, Poland

and more 57 locations

Nalmefene Smoking Cessation Study

Phase 2
Completed
Conditions
Interventions
First Posted Date
2005-09-20
Last Posted Date
2008-05-19
Lead Sponsor
Somaxon Pharmaceuticals
Target Recruit Count
76
Registration Number
NCT00202696
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

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