The Get Quit - Stay Quit Study

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.

Conditions

• Nicotine Dependent Cigarette Smoker

Interventions

BEHAVIORAL

Lung Age feedback and exhaled carbon monoxide

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.

BEHAVIORAL

No Lung Age Feedback

Those allocated to the control group will simply be informed of their scores on the spirometry.

Sponsors & Collaborators

• Milton S. Hershey Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• United States

Study Locations