Clinical trial NCT01980485: The Get Quit - Stay Quit Study
Official title: The Get Quit-Stay Quit Study: a Randomized Trial of Health Risk Feedback and Relapse Prevention for Treatment-seeking Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependent Cigarette Smoker
Keywords: smoker
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 225
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Participants must want to quit smoking and be ready to make a quit attempt within the next 30 days.
3. Participants must plan to remain in the intervention catchment area for at least 8 months.
4. Age \>18 years. Nicotine patches are not currently approved by FDA for those under age 18.
5. 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.
6. Participants must be able to read and write in English.
7. 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.
8. Ability to understand and the willingness to sign a written informed consent document

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Exclusion Criteria:

1. A history of severe allergic reaction while using a nicotine patch.
2. Currently using a drug/medicine as an aid to smoking cessation (e.g. Zyban, Chantix, nicotine replacement).
3. 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.
4. Had a heart attack, stroke, continuing arrhythmias or angina (chest pains) or abnormal electrocardiogram within the past 4 weeks.
5. Uncontrolled serious mental illness or substance abuse.
6. Uses non-cigarette tobacco products and does not plan to quit all tobacco.

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Primary outcomes:
measure: Number of Participants Reporting no Tobacco Use in the Past 7 Days and Have a Validated CO <10ppm
timeFrame: 28 days post quit date
measure: Sustained Tobacco Abstinence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Harrisburg
country: United States
facility: Penn State Hershey Medical Group Harrisburg
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Medical Group Fishburn Road
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Internal Medicine
state: Pennsylvania
city: Palmyra
country: United States
facility: Penn State Hershey Palmyra
state: Pennsylvania
Study officials:
References:
citation: 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.