Last updated: 11/04/2018 06:08:42

A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward

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GSK study ID
DAN106593
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Clinicaltrials.gov ID
NCT00605241
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomized, double-bind, placebo controlled, two-way cross-over study to assess the effects of a single dose of GSK598809, a Selective DRD3 Antagonist, in Modulating Nicotine Reward
Trial description: GSK598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will asses the effects of a single dose of GSK598809 in modulating nicotine reward in 2 cohorts of otherwise healthy male volunteers who smoke. Each cohort of subjects will receive a single dose of placebo or GSK598809 in two dosing sessions binded crossover fashine. There will be a washout period of at least seven days between each session.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Pharmacokinetics

Timeframe: through 24 hours

Secondary outcomes:

Stroop test

Timeframe: through 10 hours

Interventions:
  • Drug: GSK598809
    • Enrollment:
    29
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Mugnaini Manolo, Laura Iavarone, Palmina Cavallini, Cristiana Griffante, Beatrice Oliosi, Chiara Savoia, Ilan Rabiner, John Beaver, Caryn Lerman, Christopher Jepson, Andrew Strasser, Fabrizio Micheli, Christian Heidbreder, Anne Andorn, Emilio Merlo Pich. Occupancy of brain dopamine D3 receptors and drug craving: a translational approach . [Neuropsychopharmacology]. 2012;1-11.
    Mugnaini Manolo, Laura Iavarone, Palmina Cavallini, Cristiana Griffante, Beatrice Oliosi, Chiara Savoia, Ilan Rabiner, John Beaver, Caryn Lerman, Christopher Jepson, Andrew Strasser, Fabrizio Micheli, Christian Heidbreder, Anne Andorn, Emilio Merlo Pich. Occupancy of brain dopamine D3 receptors and drug craving: a translational approach. Neuropsychopharmacology. 2013;38(2):302-312
    Medical condition
    Substance Dependence
    Product
    GSK598809
    Collaborators
    Not applicable
    Study date(s)
    February 2008 to March 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Healthy male smokers aged 18-65 with a desire to quit smoking.
    • Body weight greater than 50kg and BMI within range 19 - 29.9 kg/m2
    • Positive pre-study urine drug/breath alcohol screen: positive HIV 1/2, Hepatitis B or Hepatitis C test at screening.
    • History of alcohol/drug abuse or dependence (other than nicotine) within 12 months of the study.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male smokers aged 18-65 with a desire to quit smoking.
    • Body weight greater than 50kg and BMI within range 19
    • 29.9 kg/m2
    • Healthy with no significant medical, psychiatric or laboratory evaluation abnormality.
    Exclusion criteria:
    • Positive pre-study urine drug/breath alcohol screen: positive HIV 1/2, Hepatitis B or Hepatitis C test at screening.
    • History of alcohol/drug abuse or dependence (other than nicotine) within 12 months of the study.
    • History of psychiatric disorder or sensitivity to any of the study medications or components thereof or a history of drug or allergy that in the opinion of the physician responsible contraindicates their participation.
    • History of cardiac or pulmonary disease/abnormalities.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19104
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2009-20-03

    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

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    Additional information
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