Effects of GSK598809 on Brain Activation in Abstinent Alcoholics
Status:
Withdrawn
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
Summary
This study will compare the effects of GSK598809 and placebo in alcohol dependent volunteers.
A placebo is a pill with no drug in it (i.e. dummy drug) but it is made to look exactly like
the real drug.
Subjects will be given one dose of GSK598809 during one visit and placebo during the other
visit. These dosing visits will be at least 1 week apart. The study is randomised, which
means that a computer programme will decide by chance (like tossing a coin), the order in
which subjects will receive GSK598809 or the placebo, or in other words, whether they will
receive GSK598809 or placebo first.
The study is blinded, which means the subjects will not know whether they are receiving study
drug or placebo first and neither will the doctors at the institute. If necessary for reasons
of safety, the study staff can find out exactly what the subject has received.
The study will last for approximately 4 weeks but could be up to 6 weeks, depending on length
of time between screening and dosing. From screening the subjects will be alcohol-abstinent,
they may be put on medication for treatment of withdrawal symptoms and then will have at
least 7 days without any medication before beginning the study medication. During the study
the subjects will be inpatients at the Central Institute of Mental Health. All subjects will
be required to fill out questionnaires, perform behavioural tasks and undergo MRI and
functional MRI (fMRI) scans.