The Get Quit - Stay Quit Study (GQSQ)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jonathan Foulds, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01980485
First received: October 24, 2013
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Nicotine Dependent Cigarette Smoker
Behavioral: Lung Age feedback and exhaled carbon monoxide
Behavioral: No Lung Age Feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Get Quit-Stay Quit Study: a Randomized Trial of Health Risk Feedback and Relapse Prevention for Treatment-seeking Smokers

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Co validated no use of tobacco in last seven days [ Time Frame: 28 days post quit date ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to relapse [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 225
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

    -

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.

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01980485

Locations
United States, Pennsylvania
Penn State Hershey Medical Group Harrisburg
Harrisburg, Pennsylvania, United States, 17102
Penn State Hershey Medical Group Fishburn Road
Hershey, Pennsylvania, United States, 17033
Penn State Hershey Internal Medicine
Hershey, Pennsylvania, United States, 17036
Penn State Hershey Palmyra
Palmyra, Pennsylvania, United States, 17038
Sponsors and Collaborators
Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Jonathan Foulds, Professor of Public Health Sciences and Psychiatry, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01980485     History of Changes
Other Study ID Numbers: 37326EP
Study First Received: October 24, 2013
Last Updated: November 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
smoker

Additional relevant MeSH terms:
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014