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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

Information source: H. Lundbeck A/S
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Dependence

Intervention: Nalmefene 18 mg, then placebo (Drug); Placebo, then Nalmefene 18 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: H. Lundbeck A/S

Official(s) and/or principal investigator(s):
Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com

Summary

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

Clinical Details

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

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

Primary outcome: Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task

Secondary outcome:

Safety

Risk of suicidality

Eligibility

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Male.

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.

Locations and Contacts

GB801, London NW10 7EW, United Kingdom
Additional Information

Starting date: November 2013
Last updated: November 10, 2014

Page last updated: August 23, 2015

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