The Get Quit - Stay Quit Study

Study Overview
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Brief Summary
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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.

Official Title
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The Get Quit-Stay Quit Study: a Randomized Trial of Health Risk Feedback and Relapse Prevention for Treatment-seeking Smokers

Conditions
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Nicotine Dependent Cigarette Smoker

Intervention / Treatment
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* Behavioral: Lung Age feedback and exhaled carbon monoxide
* Behavioral: No Lung Age Feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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 - Exclusion Criteria: 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. -

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Feedback on lung age and exhaled carbon monoxide<br> | Behavioral: Lung Age feedback and exhaled carbon monoxide<br>* 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.<br>|
| Sham Comparator: No lung age feedback<br>Those allocated to the control group will simply be informed of their scores on the spirometry. | Behavioral: No Lung Age Feedback<br>* Those allocated to the control group will simply be informed of their scores on the spirometry.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoker