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: SafetyRisk 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
|