Relapse Prevention Study in Newly Abstinent Smokers

NCT00793468 | Withdrawn Phase 2

• 1 other identifier: 108428
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Substance Dependence

Keywords

nicotine dependence; smoking; pharmacological treatment; relapse prevention

Outcome Measures

Primary Outcomes (1)

• Continuous smoking abstinence

  weeks 13 through 16

Secondary Outcomes (3)

• safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events

  weeks 1 through 16 and follow-up phase

• Weekly point prevalence abstinence

  Weeks 6, 8, 10, 12, 14, and 16

• drug exposure level

  weeks 6-16

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16.

Drug: GSK598809; Drug: Nicotine Replacement Transdermal Patch; Drug: Placebo

GSK598809 Arm

EXPERIMENTAL

Subjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16.

Drug: GSK598809; Drug: Nicotine Replacement Transdermal Patch

Interventions

GSK598809 DRUG

GSK598809 once daily for 12 weeks

GSK598809 Arm; Placebo Arm

Nicotine Replacement Transdermal Patch DRUG

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.

GSK598809 Arm; Placebo Arm

Placebo DRUG

Placebo once daily for 12 weeks

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (10)

GSK Investigational Site

DeLand, Florida, 32720, United States

Location

GSK Investigational Site

Pembroke Pines, Florida, 33024, United States

Location

GSK Investigational Site

Stockbridge, Georgia, 30281, United States

Location

GSK Investigational Site

Overland Park, Kansas, 66211, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89104, United States

Location

GSK Investigational Site

Rochester, New York, 14609, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27612, United States

Location

GSK Investigational Site

Portland, Oregon, 97239, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

GSK Investigational Site

Dallas, Texas, 75234, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Tobacco Use Disorder; Smoking

Interventions

GSK598809

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2008
• First Posted: November 19, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 15, 2016

Record last verified: 2016-02

Locations

US (10)