Interventional, Randomized, Double-blind, Cross-over, Placebo-controlled Study to Investigate the Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol Challenge

H. Lundbeck A/S1 site in 1 country22 target enrollmentNovember 2013

Overview

Phase: Phase 1
Intervention: Nalmefene 18 mg, then placebo
Conditions: Alcohol Dependence
Sponsor: H. Lundbeck A/S
Enrollment: 22
Locations: 1
Primary Endpoint: Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task
Status: Completed
Last Updated: 11 years ago

To contribute to the understanding of the underlying neurobiological mechanism behind the interaction of alcohol and nalmefene

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

October 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Sponsor

Responsible Party

Sponsor

•The subject is seeking treatment for alcohol dependence.
•The subject has had \<6 heavy drinking days (HDDs) in the 4 weeks prior to the Screening Visit.
•The subject has had an average alcohol consumption below high risk levels (that is, 60 grams of alcohol/day for men) \<4 weeks prior to the Screening Visit.
•The subject has \>5 consecutive abstinence days in the 4 weeks prior to the Screening Visit.
•The subject has a Revised Clinical Institute Withdrawal Assessment of Alcohol Scale, (CIWA-Ar), score ≥
•The subject is, in the opinion of the investigator, at significant risk of suicide or meets the exclusion criteria based on C-SSRS.
•Other inclusion and exclusion criteria may apply.