Nicotine Dependent Cigarette SmokerGQSQNCT01980485
The Get Quit - Stay Quit Study
A study testing Lung Age feedback and exhaled carbon monoxide and No Lung Age Feedback in people with Nicotine Dependent Cigarette Smoker, run by Milton S. Hershey Medical Center at 4 sites in United States.
Trial summary
Narrative: Tobacco smoking remains the single biggest cause of premature death in the United States and the leading cause of cancer and death from cancer. There is therefore an urgent need to find effective but practical ways of helping smokers to quit and stay quit. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependent Cigarette Smoker
- What is being tested?
- Lung Age feedback and exhaled carbon monoxide and No Lung Age Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must report smoking at least 5 cigarettes per day for the previous 6 months AND sometimes smoke at least 10 cigarettes in one day.
- Participants must want to quit smoking and be ready to make a quit attempt within the next 30 days.
- Participants must plan to remain in the intervention catchment area for at least 8 months.
- Age >18 years. Nicotine patches are not currently approved by FDA for those under age 18.
- Participants must be willing to attend and provide data at the 8 study visits, including an assessment visit at which a blood sample will be drawn, 6 group treatment sessions, respond to follow-up telephone calls, and a 6-month follow-up visit.
- Participants must be able to read and write in English.
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- Nicotine is known to be harmful to the developing human fetus at the recommended therapeutic dose. For this reason women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the standard duration of transdermal nicotine therapy (10 weeks). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the patient should inform the treating clinician immediately.
- Ability to understand and the willingness to sign a written informed consent document
- -
Who cannot join
- A history of severe allergic reaction while using a nicotine patch.
- Currently using a drug/medicine as an aid to smoking cessation (e.g. Zyban, Chantix, nicotine replacement).
- Currently pregnant, trying to get pregnant, or nursing, because nicotine is known to be harmful to the developing human fetus at the recommended therapeutic dose.
- Had a heart attack, stroke, continuing arrhythmias or angina (chest pains) or abnormal electrocardiogram within the past 4 weeks.
- Uncontrolled serious mental illness or substance abuse.
- Uses non-cigarette tobacco products and does not plan to quit all tobacco.
- -
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Penn State Hershey Medical Group Harrisburg
Harrisburg, Pennsylvania, 17102
Penn State Hershey Medical Group Fishburn Road
Hershey, Pennsylvania, 17033
Penn State Hershey Internal Medicine
Hershey, Pennsylvania, 17036
Penn State Hershey Palmyra
Palmyra, Pennsylvania, 17038
About this study
Official title: The Get Quit-Stay Quit Study: a Randomized Trial of Health Risk Feedback and Relapse Prevention for Treatment-seeking Smokers
Narrative: Tobacco smoking remains the single biggest cause of premature death in the United States and the leading cause of cancer and death from cancer. There is therefore an urgent need to find effective but practical ways of helping smokers to quit and stay quit. This randomized trial aims to evaluate two promising methods of helping smokers to quit and to stay quit.
Design: This is a randomized controlled smoking cessation trial with two stages.
Read more
In Stage 1, 225 smokers will be recruited and at assessment they will be randomly allocated to receiving feedback on their "Lung Age" as estimated by their Forced Expiratory volume of air from lungs in one second (FEV1), and exhaled carbon-monoxide (CO) (Intervention group 1) or to have these measured but not fed back in a manner designed to enhance motivation to quit (Control group 1). All participants will be provided with group counseling (6 weekly sessions, with the target Quit Date on the day of the second group meeting), and transdermal nicotine patches.
Main outcome measure: Stage 1, Past week tobacco abstinence biochemically validated by exhaled CO < 10 ppm at visit 7 (4 weeks after Target Quit Date).
In Stage 2 (starting visit 7), all participants attending visit 7 (28 days after their Target Quit Date), will be randomly allocated to receiving either the Forever Free relapse prevention materials (Intervention 2) http://www.smokefree.gov/pdf.html or the Surgeon General's Guide "How Tobacco Smoke Causes Disease" (Control 2) http://www.cdc.gov/tobacco/data_statistics/sgr/2010/consumer_booklet/index.htm.
All randomized participants will receive a follow-up phone call a week later to remind them to read and use the materials they have been given, and will attend a follow up visit (8), 6 months after their initial Target Quit Date.
Main outcome measure: Stage 2. Among those who have not smoked in the previous week at visit 7, sustained tobacco abstinence (including no tobacco use in prior 7 days), validated by exhaled CO < 10 ppm at the 6 month visit(8) AND not smoking for any 7 consecutive days during the prior 5 months (definition of a relapse in this study).
Hypothesis: Smokers who are provided with lung age feedback at assessment will have higher quit rates 28 days after the target quit date.
- Conditions
- Nicotine Dependent Cigarette Smoker
- Being tested
- Lung Age feedback and exhaled carbon monoxide, No Lung Age Feedback
- Keywords
- smoker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Age feedback and exhaled carbon monoxideBehavioural
In the intervention group, if the lung age is equal to or less than the individual's chronological age, he or she will be briefly informed that the test result was normal and that it is important to avoid potential future lung problems by stopping smoking. For those in the intervention group with a "normal" FEV-1, the intervention will focus on their exhaled carbon-monoxide.
If their lung age is greater than their chronological age, they will be given their "lung age" in years, and provided with a graph describing the possible decline in lung age if they continued to smoke and a full explanation.
Those in the Intervention Group will have their exhaled carbon-monoxide (CO) result explained in more detail. Non-smokers typically have an exhaled carbon-monoxide level of 0-4 parts per million, whereas smokers typically have a CO level of 8-50 ppm. CO levels return to normal within a few days of stopping smoking. Participants are provided with a full explanation.
No Lung Age FeedbackBehavioural
Those allocated to the control group will simply be informed of their scores on the spirometry.
| Study group | Role | What they receive |
|---|---|---|
| Feedback on lung age and exhaled carbon monoxide | Active comparator | Not described Receives: Behavioral: Lung Age feedback and exhaled carbon monoxide |
| No lung age feedback | Sham comparator | Those allocated to the control group will simply be informed of their scores on the spirometry. Receives: Behavioral: No Lung Age Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting no Tobacco Use in the Past 7 Days and Have a Validated CO <10ppm
Exhaled CO <10 ppm and no tobacco use in the past 7 days
Measured: 28 days post quit date
Sustained Tobacco Abstinence
Among those who have not smoked in the previous week at visit 7, sustained tobacco abstinence (including no tobacco use in prior 7 days), validated by exhaled CO < 10 ppm at the 6 month visit(8) AND not smoking for any 7 consecutive days during the prior 5 months (definition of a relapse in this study)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine Dependent Cigarette SmokerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Foulds, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980485
- Sponsor's protocol ID
- 37326EP
- Acronym
- GQSQ
- Status last verified
- Feb 2019
- First submitted
- 24 Oct 2013
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Foulds J, Veldheer S, Hrabovsky S, Yingst J, Sciamanna C, Chen G, Maccani JZ, Berg A. The effect of motivational lung age feedback on short-term quit rates in smokers seeking intensive group treatment: A randomized controlled pilot study. Drug Alcohol Depend. 2015 Aug 1;153:271-7. doi: 10.1016/j.drugalcdep.2015.05.007. Epub 2015 May 18.
PubMed 26051163
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Get Quit-Stay Quit Study: a Randomized Trial of Health Risk Feedback and Relapse Prevention for Treatment-seeking Smokers
- ClinicalTrials.gov ID
- NCT01980485
- Acronym / sponsor ID
- GQSQ / 37326EP
- Conditions
- Nicotine Dependent Cigarette Smoker
- Keywords
- smoker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Posted 4 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Narrative: Tobacco smoking remains the single biggest cause of premature death in the United States and the leading cause of cancer and death from cancer. There is therefore an urgent need to find effective but practical ways of helping smokers to quit and stay quit. This randomized trial aims to evaluate two promising methods of helping smokers to quit and to stay quit.
Design: This is a randomized controlled smoking cessation trial with two stages.
In Stage 1, 225 smokers will be recruited and at assessment they will be randomly allocated to receiving feedback on their "Lung Age" as estimated by their Forced Expiratory volume of air from lungs in one second (FEV1), and exhaled carbon-monoxide (CO) (Intervention group 1) or to have these measured but not fed back in a manner designed to enhance motivation to quit (Control group 1). All participants will be provided with group counseling (6 weekly sessions, with the target Quit Date on the day of the second group meeting), and transdermal nicotine patches.
Main outcome measure: Stage 1, Past week tobacco abstinence biochemically validated by exhaled CO < 10 ppm at visit 7 (4 weeks after Target Quit Date).
In Stage 2 (starting visit 7), all participants attending visit 7 (28 days after their Target Quit Date), will be randomly allocated to receiving either the Forever Free relapse prevention materials (Intervention 2) http://www.smokefree.gov/pdf.html or the Surgeon General's Guide "How Tobacco Smoke Causes Disease" (Control 2) http://www.cdc.gov/tobacco/data_statistics/sgr/2010/consumer_booklet/index.htm.
All randomized participants will receive a follow-up phone call a week later to remind them to read and use the materials they have been given, and will attend a follow up visit (8), 6 months after their initial Target Quit Date.
Main outcome measure: Stage 2. Among those who have not smoked in the previous week at visit 7, sustained tobacco abstinence (including no tobacco use in prior 7 days), validated by exhaled CO < 10 ppm at the 6 month visit(8) AND not smoking for any 7 consecutive days during the prior 5 months (definition of a relapse in this study).
Hypothesis: Smokers who are provided with lung age feedback at assessment will have higher quit rates 28 days after the target quit date.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback on lung age and exhaled carbon monoxide | Active comparator | Behavioral: Lung Age feedback and exhaled carbon monoxide |
| No lung age feedback | Sham comparator | Behavioral: No Lung Age FeedbackThose allocated to the control group will simply be informed of their scores on the spirometry. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must report smoking at least 5 cigarettes per day for the previous 6 months AND sometimes smoke at least 10 cigarettes in one day.
- Participants must want to quit smoking and be ready to make a quit attempt within the next 30 days.
- Participants must plan to remain in the intervention catchment area for at least 8 months.
- Age >18 years. Nicotine patches are not currently approved by FDA for those under age 18.
- Participants must be willing to attend and provide data at the 8 study visits, including an assessment visit at which a blood sample will be drawn, 6 group treatment sessions, respond to follow-up telephone calls, and a 6-month follow-up visit.
Key exclusion criteria (7 listed)
- A history of severe allergic reaction while using a nicotine patch.
- Currently using a drug/medicine as an aid to smoking cessation (e.g. Zyban, Chantix, nicotine replacement).
- Currently pregnant, trying to get pregnant, or nursing, because nicotine is known to be harmful to the developing human fetus at the recommended therapeutic dose.
- Had a heart attack, stroke, continuing arrhythmias or angina (chest pains) or abnormal electrocardiogram within the past 4 weeks.
- Uncontrolled serious mental illness or substance abuse.
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 |
|---|---|---|
| Lung Age feedback and exhaled carbon monoxideIn the intervention group, if the lung age is equal to or less than the individual's chronological age, he or she will be briefly informed that the test result was normal and that it is important to avoid potential future lung problems by stopping smoking. For those in the intervention group with a "normal" FEV-1, the intervention will focus on their exhaled carbon-monoxide. If their lung age is greater than their chronological age, they will be given their "lung age" in years, and provided with a graph describing the possible decline in lung age if they continued to smoke and a full explanation. Those in the Intervention Group will have their exhaled carbon-monoxide (CO) result explained in more detail. Non-smokers typically have an exhaled carbon-monoxide level of 0-4 parts per million, whereas smokers typically have a CO level of 8-50 ppm. CO levels return to normal within a few days of stopping smoking. Participants are provided with a full explanation. | Behavioural | Feedback on lung age and exhaled carbon monoxide |
| No Lung Age FeedbackThose allocated to the control group will simply be informed of their scores on the spirometry. | Behavioural | No lung age feedback |
Primary outcome
Number of Participants Reporting no Tobacco Use in the Past 7 Days and Have a Validated CO <10ppm
Time frame: 28 days post quit date
Exhaled CO <10 ppm and no tobacco use in the past 7 days
Sustained Tobacco Abstinence
Time frame: 6 months
Among those who have not smoked in the previous week at visit 7, sustained tobacco abstinence (including no tobacco use in prior 7 days), validated by exhaled CO < 10 ppm at the 6 month visit(8) AND not smoking for any 7 consecutive days during the prior 5 months (definition of a relapse in this study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26051163Foulds J, Veldheer S, Hrabovsky S, Yingst J, Sciamanna C, Chen G, Maccani JZ, Berg A. The effect of motivational lung age feedback on short-term quit rates in smokers seeking intensive group treatment: A randomized controlled pilot study. Drug Alcohol Depend. 2015 Aug 1;153:271-7. doi: 10.1016/j.drugalcdep.2015.05.007. Epub 2015 May 18.
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Age feedback and exhaled carbon monoxide and No Lung Age Feedback in people with Nicotine Dependent Cigarette Smoker, run by Milton S. Hershey Medical Center at 4 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Reporting no Tobacco Use in the Past 7 Days and Have a Validated CO <10ppm (time frame: 28 days post quit date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01980485, which also lists 1 linked publication.
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 26 Feb 2019.