Clinical trial NCT00793468: Relapse Prevention Study in Newly Abstinent Smokers
Official title: A Study to Investigate the Effects of GSK598809 in Newly Abstinent Nicotine-dependent Subjects.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Substance Dependence
Keywords: nicotine dependence
smoking
pharmacological treatment
relapse prevention
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Continuous smoking abstinence
timeFrame: weeks 13 through 16
Secondary outcomes:
measure: safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events
timeFrame: weeks 1 through 16 and follow-up phase
measure: Weekly point prevalence abstinence
timeFrame: Weeks 6, 8, 10, 12, 14, and 16
measure: drug exposure level
timeFrame: weeks 6-16
Other outcomes:
Locations:
city: Deland
country: United States
facility: GSK Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Investigational Site
state: Florida
city: Stockbridge
country: United States
facility: GSK Investigational Site
state: Georgia
city: Overland Park
country: United States
facility: GSK Investigational Site
state: Kansas
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Rochester
country: United States
facility: GSK Investigational Site
state: New York
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: