A Study to Investigate the Effects of GSK598809 in Newly Abstinent Nicotine-dependent Subjects.
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- GlaxoSmithKline
- Locations
- 1
- Primary Endpoint
- Continuous smoking abstinence
Study Overview
Brief Summary
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.
Detailed Description
The primary objective of this study is to evaluate the efficacy of GSK598809 compared to placebo for the prevention of relapse to smoking in recently abstinent smokers. Subjects who meet eligibility criteria will enter a 4-week open label treatment period during which they will receive nicotine replacement therapy (NRT). Subjects who have achieved at least one week of abstinence during the last week of an open label treatment period will be randomized to either GSK598809 or placebo in the double-blind treatment period and followed for another 12 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo Arm
Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.
Intervention: GSK598809 (Drug)
Placebo Arm
Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.
Intervention: Nicotine Replacement Transdermal Patch (Drug)
Placebo Arm
Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.
Intervention: Placebo (Drug)
GSK598809 Arm
Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16.
Intervention: GSK598809 (Drug)
GSK598809 Arm
Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16.
Intervention: Nicotine Replacement Transdermal Patch (Drug)
Outcomes
Primary Outcomes
Continuous smoking abstinence
Time Frame: weeks 13 through 16
Secondary Outcomes
- drug exposure level(weeks 6-16)
- Weekly point prevalence abstinence(Weeks 6, 8, 10, 12, 14, and 16)
- safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events(weeks 1 through 16 and follow-up phase)