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

Study Overview
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Brief Summary
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To contribute to the understanding of the underlying neurobiological mechanism behind the interaction of alcohol and nalmefene

Official Title
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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

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Drug: Nalmefene 18 mg, then placebo
* Drug: Placebo, then Nalmefene 18 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nalmefene 18 mg, then placebo<br>18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride | Drug: Nalmefene 18 mg, then placebo<br>* One single oral dose Nalmefene on Day 1 and Placebo on Day 8<br>* Other names: Selincro®;|
| Placebo Comparator: Placebo, then Nalmefene 18 mg<br>18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride | Drug: Placebo, then Nalmefene 18 mg<br>* One single oral dose Placebo on Day 1 and Nalmefene on Day 8<br>* Other names: Selincro®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

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