Status:
WITHDRAWN
Effects of GSK598809 on Brain Activation in Abstinent Alcoholics
Lead Sponsor:
GlaxoSmithKline
Conditions:
Substance Dependence
Alcohol Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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...
Detailed Description
This is a randomised, placebo controlled, cross-over, single-blind study of the effects of GSK598809 (175 mg, single dose) on multiple pharmacodynamic measures assessed by fMRI and rating scales. In o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00908206
Start Date
May 1 2009
End Date
July 1 2009
Last Update
April 17 2015
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