Relapse Prevention Study in Newly Abstinent Smokers

This study has been terminated.
(study recruitment temporarily on hold)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00793468
First received: November 18, 2008
Last updated: October 27, 2014
Last verified: October 2014

November 18, 2008
October 27, 2014
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 replacfement 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: double blind treatment
    Once subjects complete a 4 week open label period and are eligible to continue, they will start 12 week double blind treaqtment period. For the first week of double blind treatment, subjects will continue to receive nicotine replacement therapy.
  • Drug: open label
    Subjects who meet inclusion and exclusion criteria will first enter 4 week open label period of nicotine replacement therapy before they start the 12 week double blind treatment period.
  • Placebo Comparator: placebo arm
    Subjects will enter into a 4-week open label period of nicotine replacement therapy and then are randomized into either placebo arm or GSK598809 arm. Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.
    Interventions:
    • Drug: double blind treatment
    • Drug: open label
  • Experimental: GSK598809 arm
    Subjects will enter into a 4-week open label period of nicotine replacement therapy and then are randomized into either placebo arm or GSK598809 arm. Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16.
    Interventions:
    • Drug: double blind treatment
    • Drug: open label
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
425
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
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2014

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