Relapse Prevention Study in Newly Abstinent Smokers

Substance Dependence Clinical Trial

Official title:

A Study to Investigate the Effects of GSK598809 in Newly Abstinent Nicotine-dependent Subjects.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00793468
• Other study ID #: 108428
• Status: Withdrawn
• Phase: Phase 2
• First received: November 18, 2008
• Last updated: February 11, 2016
• Start date: December 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance Dependence
• Substance-Related Disorders

Intervention

Drug:
• GSK598809
GSK598809 once daily for 12 weeks
• Nicotine 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.
• Placebo
Placebo once daily for 12 weeks

Locations

Country	Name	City	State
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Deland	Florida
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Overland Park	Kansas
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Stockbridge	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous smoking abstinence		weeks 13 through 16	No
Secondary	safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events		weeks 1 through 16 and follow-up phase	Yes
Secondary	Weekly point prevalence abstinence		Weeks 6, 8, 10, 12, 14, and 16	No
Secondary	drug exposure level		weeks 6-16	No