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Effects of GSK598809 on Brain Activation in Abstinent Alcoholics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00908206
Recruitment Status : Withdrawn (Study not approved by BfARM)
First Posted : May 25, 2009
Last Update Posted : April 17, 2015
Information provided by:

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.

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.

Condition or disease Intervention/treatment Phase
Substance Dependence Alcohol Dependence Drug: GSK598809 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo to match GSK598809.
Drug: GSK598809
Subjects will receive a single 175 mg oral dose of GSK598809.

Primary Outcome Measures :
  1. BOLD signal changes in the relevant brain areas following presentation of visual alcohol-related vs neutral, non-alcohol related cues. [ Time Frame: 1.5h (± 0.5h) after each dose (2 doses) ]
  2. BOLD signal changes in the same brain structures and circuits as above during a Monetary Incentive Delay task. [ Time Frame: 1.5h (± 0.5h) after each dose (2 doses) ]

Secondary Outcome Measures :
  1. Subjective craving in response to alcohol-related cues measured with the Alcohol Urge Questionnaire (AUQ) and the Obsessive Compulsive Drinking Scale (OCDS). [ Time Frame: Screening and pre-scan. ]
  2. 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. [ Time Frame: Throughout study. ]
  3. Pharmacokinetic parameters of GSK598809 and its metabolite GSK685249: AUC (0-∞), Cmax, tmax, t½. [ Time Frame: Pre-dose to 48h post dose. ]
  4. 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. [ Time Frame: 1.5h (± 0.5h) after each dose (2 doses) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00908206

Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00908206    
Other Study ID Numbers: 109709
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
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Substance-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders