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 Followi

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Nalmefene; Naltrexone

Criteria

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.