Skip to main content
OpenTrials
Completed

NCT Number: NCT01969617

Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) 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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

20 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GB801

London, NW10 7EW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject has alcohol dependence, diagnosed according to DSM-IV-TR™.

Exclusion criteria

  • 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 ≥10.
  • 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.

Treatment and study plan

Nalmefene 18 mg, then placebo

Drug

One single oral dose Nalmefene on Day 1 and Placebo on Day 8

Other names: Selincro®

Placebo, then Nalmefene 18 mg

Drug

One single oral dose Placebo on Day 1 and Nalmefene on Day 8

Other names: Selincro®

Primary outcomes

  1. Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task

    Time frame: Day 1

Secondary outcomes

  1. Safety

    Time frame: Up to Day 8 and a 10-day safety follow up

    Number of adverse events

  2. Risk of suicidality

    Time frame: Up to Day 8

    Columbia-Suicide Severity Rating Scale (CSSRS) score

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
First posted
Oct 25, 2013
Registry last updated
Nov 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.