Last updated: 11/03/2018 09:58:44

Relapse prevention study in newly abstinent smokers

GSK study ID
108428
Clinicaltrials.gov ID
NCT00793468
EudraCT ID
Not applicable
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 study to investigate the effects of GSK598809 in newly abstinent nicotine-dependent subjects.
Trial description: The purpose of this study is to determine the effect of GSK598809 as compared to placebo in preventing recently-quit smokers from going back to smoking.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Continuous smoking abstinence

Timeframe: weeks 13 through 16

Secondary outcomes:

safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events

Timeframe: weeks 1 through 16 and follow-up phase

Weekly point prevalence abstinence

Timeframe: Weeks 6, 8, 10, 12, 14, and 16

drug exposure level

Timeframe: weeks 6-16

Interventions:
  • Drug: GSK598809
  • Drug: Nicotine Replacement Transdermal Patch
  • Drug: Placebo
    • 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)
    December 2008 to December 2008
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • has smoked at least 10 cigarettes a day for at least 2 years
    • has had multiple previous attempts to quit smoking and relapsed to smoking.
    • cannot be using smokeless tobacco of any type or has tried to quit with medicine.
    • does not abuse alcohol or drugs
    Inclusion and exclusion criteria
    Inclusion criteria:
    • has smoked at least 10 cigarettes a day for at least 2 years
    • has had multiple previous attempts to quit smoking and relapsed to smoking.
    • generally healthy
    Exclusion criteria:
    • cannot be using smokeless tobacco of any type or has tried to quit with medicine.
    • does not abuse alcohol or drugs
    • certain emotional problems being treated with medications
    • pregnant or breast feeding female

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97239
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Stockbridge, Georgia, United States, 30281
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Rochester, New York, United States, 14609
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Deland, Florida, United States, 32720
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19104
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89104
    Status
    Study Complete
    Contact us
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    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
    2008-01-12

    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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