Substance DependencePhase 2NCT00793468
Relapse Prevention Study in Newly Abstinent Smokers
A Phase 2 study testing GSK598809 and Nicotine Replacement Transdermal Patch in people with Substance Dependence, run by GlaxoSmithKline at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Dependence
- What is being tested?
- GSK598809 and Nicotine Replacement Transdermal Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2008to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
GSK Investigational Site
Dallas, Texas, 75234
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Las Vegas, Nevada, 89104
GSK Investigational Site
Overland Park, Kansas, 66211
GSK Investigational Site
Pembroke Pines, Florida, 33024
GSK Investigational Site
Philadelphia, Pennsylvania, 19104
GSK Investigational Site
Portland, Oregon, 97239
GSK Investigational Site
Raleigh, North Carolina, 27612
GSK Investigational Site
Rochester, New York, 14609
GSK Investigational Site
Stockbridge, Georgia, 30281
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Dependence
- Being tested
- GSK598809, Nicotine Replacement Transdermal Patch, Placebo
- Keywords
- nicotine dependence, smoking, pharmacological treatment, relapse prevention
- Medical subject headings
- Substance-Related Disorders, Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK598809Drug
GSK598809 once daily for 12 weeks
Nicotine Replacement Transdermal PatchDrug
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.
PlaceboDrug
Placebo once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | Subjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16. Receives: 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. Receives: Drug: GSK598809; Drug: Nicotine Replacement Transdermal Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous smoking abstinence
Measured: weeks 13 through 16
Secondary outcomes (3)
safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events
Measured: weeks 1 through 16 and follow-up phase
Weekly point prevalence abstinence
Measured: Weeks 6, 8, 10, 12, 14, and 16
drug exposure level
Measured: weeks 6-16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2008
- Study completionDec 2008 (estimated)
Why it stopped: Study halted prior to enrollment of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance DependenceStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793468
- Sponsor's protocol ID
- 108428
- Status last verified
- Feb 2016
- First submitted
- 18 Nov 2008
- Last updated
- 15 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Effects of GSK598809 in Newly Abstinent Nicotine-dependent Subjects.
- ClinicalTrials.gov ID
- NCT00793468
- Acronym / sponsor ID
- 108428
- Conditions
- Substance Dependence
- Keywords
- nicotine dependence, smoking, pharmacological treatment, relapse prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prior to enrollment of patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (estimated)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Drug: GSK598809, Drug: Nicotine Replacement Transdermal Patch, Drug: PlaceboSubjects in placebo arm will be taking placebo once daily for 12 weeks from week 5 to 16. |
| GSK598809 Arm | Experimental | Drug: GSK598809, Drug: Nicotine Replacement Transdermal PatchSubjects in GSK598809 arm will be taking GSK598809 once daily for 12 weeks from weeks 5 to 16. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK598809GSK598809 once daily for 12 weeks | Drug | GSK598809 Arm, Placebo Arm |
| Nicotine Replacement Transdermal PatchAll 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 | GSK598809 Arm, Placebo Arm |
| PlaceboPlacebo once daily for 12 weeks | Drug | Placebo Arm |
Primary outcome
Continuous smoking abstinence
Time frame: weeks 13 through 16
3 secondary outcomes
safety endpoints including vital signs, weight, ECGs, safety laboratory test and adverse events
Time frame: weeks 1 through 16 and follow-up phase
Weekly point prevalence abstinence
Time frame: Weeks 6, 8, 10, 12, 14, and 16
drug exposure level
Time frame: weeks 6-16
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK598809 and Nicotine Replacement Transdermal Patch in people with Substance Dependence, run by GlaxoSmithKline at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous smoking abstinence (time frame: weeks 13 through 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2016.