Relapse Prevention Study in Newly Abstinent Smokers

This study has been withdrawn prior to enrollment.
(Study halted prior to enrollment of patients)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00793468
First received: November 18, 2008
Last updated: February 11, 2016
Last verified: February 2016

November 18, 2008
February 11, 2016
December 2008
December 2008   (final data collection date for primary outcome measure)
Continuous smoking abstinence [ Time Frame: weeks 13 through 16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00793468 on ClinicalTrials.gov Archive Site
  • safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events [ Time Frame: weeks 1 through 16 and follow-up phase ] [ Designated as safety issue: Yes ]
  • Weekly point prevalence abstinence [ Time Frame: Weeks 6, 8, 10, 12, 14, and 16 ] [ Designated as safety issue: No ]
  • drug exposure level [ Time Frame: weeks 6-16 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Relapse Prevention Study in Newly Abstinent Smokers
A Study to Investigate the Effects of GSK598809 in Newly Abstinent Nicotine-dependent Subjects.
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.
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Substance Dependence
  • Drug: GSK598809
    GSK598809 once daily for 12 weeks
  • Drug: 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.
  • Drug: Placebo
    Placebo once daily for 12 weeks
  • Placebo Comparator: Placebo Arm
    Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.
    Interventions:
    • Drug: GSK598809
    • Drug: Nicotine Replacement Transdermal Patch
    • Drug: Placebo
  • Experimental: GSK598809 Arm
    Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16.
    Interventions:
    • Drug: GSK598809
    • Drug: Nicotine Replacement Transdermal Patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00793468
108428
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP