Last updated: 11/03/2018 10:35:16

Effects of GSK598809 on brain activation in abstinent alcoholics

GSK study ID
109709
Clinicaltrials.gov ID
NCT00908206
EudraCT ID
2008-004750-32
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

BOLD signal changes in the relevant brain areas following presentation of visual alcohol-related vs neutral, non-alcohol related cues.

Timeframe: 1.5h (± 0.5h) after each dose (2 doses)

BOLD signal changes in the same brain structures and circuits as above during a Monetary Incentive Delay task.

Timeframe: 1.5h (± 0.5h) after each dose (2 doses)

Secondary outcomes:

Subjective craving in response to alcohol-related cues measured with the Alcohol Urge Questionnaire (AUQ) and the Obsessive Compulsive Drinking Scale (OCDS).

Timeframe: Screening and pre-scan.

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.

Timeframe: Throughout study.

Pharmacokinetic parameters of GSK598809 and its metabolite GSK685249: AUC (0-∞), Cmax, tmax, t½.

Timeframe: Pre-dose to 48h post dose.

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.

Timeframe: 1.5h (± 0.5h) after each dose (2 doses)

Interventions:
  • Drug: GSK598809
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Substance Dependence
    Product
    GSK598809
    Collaborators
    Not applicable
    Study date(s)
    September 2009 to March 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • Alcohol dependent for at least 2 years.
    • Willing to use appropriate contraception method.
    • Heavy smokers (more than 25 cigarettes per day).
    • Liver cirrhosis.
    Inclusion and exclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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