Relapse Prevention Study in Newly Abstinent Smokers - Full Text View

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 Smoking	Drug: double blind treatment Drug: open label	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:

MedlinePlus related topics: Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

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 ]

Estimated Enrollment:	425
Study Start Date:	December 2008
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 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.	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.
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.	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.

Arms

Assigned Interventions

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.

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.

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.

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.

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
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

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, 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, 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

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00793468 History of Changes
Other Study ID Numbers:	108428
Study First Received:	November 18, 2008
Last Updated:	February 20, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

nicotine dependence
smoking
pharmacological treatment
relapse prevention

Additional relevant MeSH terms:

Smoking
Substance-Related Disorders
Habits
Mental Disorders
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013