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

November 10, 2014 updated by: H. Lundbeck A/S

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nalmefene 18 mg, then placebo
18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride
Drug: Nalmefene 18 mg, then placebo
One single oral dose Nalmefene on Day 1 and Placebo on Day 8
Other Names:
  • Selincro®
Placebo Comparator: Placebo, then Nalmefene 18 mg
18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride
Drug: Placebo, then Nalmefene 18 mg
One single oral dose Placebo on Day 1 and Nalmefene on Day 8
Other Names:
  • Selincro®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: Up to Day 8 and a 10-day safety follow up
Number of adverse events
Up to Day 8 and a 10-day safety follow up
Risk of suicidality
Time Frame: Up to Day 8
Columbia-Suicide Severity Rating Scale (CSSRS) score
Up to Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

October 17, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimate)

October 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 11, 2014

Last Update Submitted That Met QC Criteria

November 10, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15660A
  • 2013-001154-98 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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