Overview

Effects of GSK598809 on Brain Activation in Abstinent Alcoholics

Status:
Withdrawn
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Criteria
Inclusion Criteria:

- Alcohol dependent for at least 2 years.

- Willing to use appropriate contraception method.

- Weight less than 120 kg.

- BMI within the range 18.5 - 33 kg/m2.

Exclusion Criteria:

- Heavy smokers (more than 25 cigarettes per day).

- Liver cirrhosis.

- Pregnant or breast feeding female.

- Psychiatric disorder.

- Substance dependence or abuse other than alcoholism and nicotine dependence.

- Medical illness.

- ECG abnormality (personal or family history).

- Sudden unexplained death or syncope in first degree relative.