The Get Quit - Stay Quit Study (GQSQ)

February 5, 2019 updated by: Jonathan Foulds, Milton S. Hershey Medical Center

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17102
        • Penn State Hershey Medical Group Harrisburg
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Group Fishburn Road
      • Hershey, Pennsylvania, United States, 17036
        • Penn State Hershey Internal Medicine
      • Palmyra, Pennsylvania, United States, 17038
        • Penn State Hershey Palmyra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

    -

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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
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.
Sham Comparator: No lung age feedback
Those allocated to the control group will simply be informed of their scores on the spirometry.
Behavioral: No Lung Age Feedback
Those allocated to the control group will simply be informed of their scores on the spirometry.

What is the study measuring?

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
Time Frame: 28 days post quit date
Exhaled CO <10 ppm and no tobacco use in the past 7 days
28 days post quit date
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)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

November 4, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 5, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37326EP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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