Alcohol Dependence Clinical Trial
Official title:
A Placebo-controlled, Single-blind, Cross-over, Randomised, fMRI Study Comparing Cue-induced Brain Activation Patterns After a Single Oral Dose of GSK598809 or Placebo in Abstinent Alcoholic Subjects
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BOLD signal changes in the relevant brain areas following presentation of visual alcohol-related vs neutral, non-alcohol related cues. | 1.5h (± 0.5h) after each dose (2 doses) | No | |
Primary | BOLD signal changes in the same brain structures and circuits as above during a Monetary Incentive Delay task. | 1.5h (± 0.5h) after each dose (2 doses) | No | |
Secondary | Subjective craving in response to alcohol-related cues measured with the Alcohol Urge Questionnaire (AUQ) and the Obsessive Compulsive Drinking Scale (OCDS). | Screening and pre-scan. | No | |
Secondary | Spontaneously reported adverse events, laboratory values, cardiovascular variables (blood pressure, heart rate, and ECG variables), temperature, respiratory rate, serum prolactin concentrations, TSH, testosterone, LH and FSH. | Throughout study. | Yes | |
Secondary | Pharmacokinetic parameters of GSK598809 and its metabolite GSK685249: AUC (0-8), Cmax, tmax, t½. | Pre-dose to 48h post dose. | No | |
Secondary | Pair-wise correlation of BOLD signal changes in different image voxels and between selected brain structures during the alcohol-related cue paradigm and the Monetary Incentive Delay task, and in the brain resting state. | 1.5h (± 0.5h) after each dose (2 doses) | No |
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