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

Alcohol Dependence Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969617
• Other study ID #: 15660A
• Secondary ID: 2013-001154-98
• Status: Completed
• Phase: Phase 1
• First received: October 17, 2013
• Last updated: November 10, 2014
• Start date: November 2013

Study information

• Verified date: November 2014
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Nalmefene 18 mg, then placebo
One single oral dose Nalmefene on Day 1 and Placebo on Day 8
• Placebo, then Nalmefene 18 mg
One single oral dose Placebo on Day 1 and Nalmefene on Day 8

Locations

Country	Name	City	State
United Kingdom	GB801	London

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task		Day 1	No
Secondary	Safety	Number of adverse events	Up to Day 8 and a 10-day safety follow up	Yes
Secondary	Risk of suicidality	Columbia-Suicide Severity Rating Scale (CSSRS) score	Up to Day 8	Yes