Last updated: 11/03/2018 09:58:44
Relapse prevention study in newly abstinent smokers
GSK study ID
108428
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
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
Observational study model:
Not applicable
Primary completion date:
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
GSK Investigational Site
Portland, Oregon, United States, 97239
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rochester, New York, United States, 14609
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Deland, Florida, United States, 32720
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66211
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Dallas, Texas, United States, 75234
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
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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