Alcohol Dependence
Conditions
Brief summary
To contribute to the understanding of the underlying neurobiological mechanism behind the interaction of alcohol and nalmefene
Interventions
DRUGNalmefene 18 mg, then placebo
One single oral dose Nalmefene on Day 1 and Placebo on Day 8
DRUGPlacebo, then Nalmefene 18 mg
One single oral dose Placebo on Day 1 and Nalmefene on Day 8
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety | Up to Day 8 and a 10-day safety follow up | Number of adverse events |
| Risk of suicidality | Up to Day 8 | Columbia-Suicide Severity Rating Scale (CSSRS) score |
Countries
United Kingdom
Outcome results
None listed