Substance Dependence
Conditions
Keywords
nicotine dependence, smoking, pharmacological treatment, relapse prevention
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.
Interventions
DRUGGSK598809
GSK598809 once daily for 12 weeks
DRUGNicotine Replacement Transdermal Patch
All subjects will be treated during the 4 week open-label smoking cessation phase of the study. During Weeks 1-3, subjects will receive 21mg/day, and during Week 4, subjects will receive 14 mg/day. Those subjects who reached continuous abstinence on at least week 4 of the open-label phase will receive 7mg/day during Week 5 while taking GSK598809 or placebo.
DRUGPlacebo
Placebo once daily for 12 weeks
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Continuous smoking abstinence | weeks 13 through 16 |
Secondary
| Measure | Time frame |
|---|---|
| safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events | weeks 1 through 16 and follow-up phase |
| Weekly point prevalence abstinence | Weeks 6, 8, 10, 12, 14, and 16 |
| drug exposure level | weeks 6-16 |
Countries
United States
Outcome results
None listed