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Nalmefene

DRUG20 trials

Sponsors

Somaxon Pharmaceuticals, H. Lundbeck A/S, Central Institute of Mental Health, Mannheim, University of Bordeaux, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Conditions

AUDAlcohol DependenceAlcohol UseAlcohol Use DisorderAlcoholismAnesthesiaBehavioural AddictionBorderline Personality Disorder

Early Phase 1

Single-dose of Nalmefene to Modulate Neural Alcohol Cue Reactivity
TerminatedNCT02372318
Central Institute of Mental Health, MannheimAlcoholism
Start: 2015-04-30End: 2016-05-31Updated: 2017-07-02

Phase 1

Title: Effect of Opioid Receptor Modulation on Alcohol Self-Administration and Neural Response to Alcohol Cues in Heavy Drinkers: Role of OPRM1 Gene Variation
CompletedNCT02639273
National Institute on Alcohol Abuse and Alcoholism (NIAAA)AUD
Start: 2016-06-08End: 2023-12-08Updated: 2025-11-21
Pharmacokinetic Evaluation of Nalmefene Administered Intranasally to Healthy Volunteers
CompletedNCT03129347
National Institute on Drug Abuse (NIDA)Opioid-Related Disorders
Start: 2017-06-01End: 2017-07-03Updated: 2018-03-26
St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Nalmefene
CompletedNCT03278886
Boston Medical CenterAlcohol Use, HIV Infection, Pain
Start: 2018-07-03End: 2018-12-19Updated: 2020-08-24
Patient Driven Recovery With Nalmefene and Coaching
CompletedNCT03279562
Yale UniversityHarmful; Use, Alcohol, Opioid-use Disorder
Start: 2017-09-01End: 2019-12-30Updated: 2021-01-22
Pharmacokinetic Evaluation of Intranasal Nalmefene
CompletedNCT04759768
Opiant Pharmaceuticals IncPharmacokinetics
Start: 2021-02-08End: 2021-05-24Updated: 2024-08-13
An Evaluation of The Absolute Bioavailability of TH104
CompletedNCT06198686
Tharimmune IncHealthy
Start: 2024-01-26End: 2024-11-06Updated: 2025-04-08

Phase 2

Nalmefene Smoking Cessation Study
CompletedNCT00202696
Somaxon PharmaceuticalsSmoking Cessation
Start: 2005-09-30End: 2006-03-31Updated: 2008-05-19
Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label Study
NCT02934919
University Hospital, Clermont-FerrandImpulse Control Disorders, Parkinson Disease
Start: 2016-12-31End: 2018-05-31Target: 30Updated: 2016-10-17
Nalmefene, Baclofen and Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects
CompletedNCT03034408
Prof. Daniele ZullinoAlcohol Use Disorder
Start: 2016-07-01End: 2018-12-17Updated: 2020-10-29
TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis
Not yet recruitingNCT06733519
Tharimmune IncPrimary Biliary Cholangitis, Pruritus
Start: 2026-06-01End: 2027-06-01Target: 40Updated: 2025-09-09

Phase 3

Efficacy of Nalmefene in Patients With Alcohol Dependence
CompletedNCT00811720
H. Lundbeck A/SAlcohol Dependence
Start: 2008-12-31End: 2010-11-30Updated: 2013-07-09
Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence
CompletedNCT00811941
H. Lundbeck A/SAlcohol Dependence
Start: 2009-03-31End: 2010-11-30Updated: 2013-08-07
Efficacy of Nalmefene in Patients With Alcohol Dependence
CompletedNCT00812461
H. Lundbeck A/SAlcohol Dependence
Start: 2009-03-31End: 2011-04-30Updated: 2013-07-22
NAlmefene Versus Placebo in Addition to Treatment as Usual on Craving in Behavioural Addictions
RecruitingNCT05540288
Nantes University HospitalBehavioural Addiction
Start: 2023-03-31End: 2027-07-31Target: 266Updated: 2025-02-12

Phase 4

Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use
CompletedNCT02197598
H. Lundbeck A/SAlcohol Dependence
Start: 2014-09-30Updated: 2016-12-14
Effect of Nalmefene on the Quality of Resuscitation in Patients Under General Anesthesia
CompletedNCT04713358
RenJi HospitalResuscitation
Start: 2021-09-24End: 2023-12-31Updated: 2026-02-25

Unknown Phase

Use of Selincro and Impact on Usual Practice
CompletedNCT02492581
University of BordeauxAlcohol Dependence
Start: 2016-02-29End: 2018-04-30Updated: 2018-05-14
Nalmefene in Alcohol Dependence and Borderline Personality Disorder
NCT02752503
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauAlcohol Use Disorder, Borderline Personality Disorder
Start: 2015-03-31Target: 30Updated: 2016-04-27
Effect of Dexmedetomidine Combined With Low-dose Nalmefene on Preventing Remifentanil-induced Postoperative Hyperalgesia
CompletedNCT03096730
Tianjin Medical University General HospitalAnesthesia, Pain
Start: 2017-02-06End: 2017-12-30Updated: 2021-08-03

Related Papers

Efficacy of low-dose nalmefene on recovery from general anaesthesia in adult patients: a multicentre randomised controlled study.
2026-03-10
Pharmacokinetic Properties of an FDA‐approved Intranasal Nalmefene Formulation for the Treatment of Opioid Overdose
Clinical Pharmacology in Drug Development2023-07-2727 citations
The efficacy of nalmefene on anesthetic recovery of patients: a study protocol for a multicenter randomized controlled trial
Trials2023-03-01
The effects of nalmefene on the impulsive and reflective system in alcohol use disorder: A resting-state fMRI study
Psychopharmacology2022-04-159 citations
Pilot study of tolerability and safety of opioid receptor antagonists as novel therapies for chronic pain among persons living with HIV with past year heavy drinking: a randomized controlled trial
AIDS Care2021-03-074 citations
P-81SECONDARY BENEFITS OF ALCOHOL REDUCTION WITH NALMEFENE
Alcohol and Alcoholism2015-09-01
Clinical Relevance of As-Needed Treatment with Nalmefene in Alcohol-Dependent Patients
European Addiction Research2015-01-0138 citations
The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model
BMJ Open2014-09-0142 citations
EPA-0255 – Clinical relevance of as-needed treatment with nalmefene in alcohol dependent patients
European Psychiatry2014-01-011 citations
Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies.
2013-07-1989 citations