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

Phase 1

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: Nalmefene 18 mg, then placebo; Drug: Placebo, then Nalmefene 18 mg

• Registration Number: NCT01969617
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-21
• Study First Posted: 2013-10-25
• Study Start: 2013-11
• Primary Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-10
• Last Update Posted: 2014-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nalmefene 18 mg, then placebo	Nalmefene 18 mg, then placebo	18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride
Placebo, then Nalmefene 18 mg	Placebo, then Nalmefene 18 mg	18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GB801; 🇬🇧 London, United Kingdom