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This study has been withdrawn prior to enrollment.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
  Purpose
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.

Condition Intervention Phase
Substance Dependence
Drug: GSK598809
Drug: Nicotine Replacement Transdermal Patch
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Effects of GSK598809 in Newly Abstinent Nicotine-dependent Subjects.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Continuous smoking abstinence [ Time Frame: weeks 13 through 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: December 2008
Estimated Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Arm
Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.
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
Experimental: GSK598809 Arm
Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16.
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.

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793468

Locations
United States, Florida
GSK Investigational Site
Deland, Florida, United States, 32720
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
United States, Georgia
GSK Investigational Site
Stockbridge, Georgia, United States, 30281
United States, Kansas
GSK Investigational Site
Overland Park, Kansas, United States, 66211
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
United States, New York
GSK Investigational Site
Rochester, New York, United States, 14609
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75234
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00793468     History of Changes
Other Study ID Numbers: 108428 
Study First Received: November 18, 2008
Last Updated: February 11, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
nicotine dependence
smoking
pharmacological treatment
relapse prevention

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2016