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NCT01980485 · ClinicalTrials.gov registry record · NA
The Get Quit - Stay Quit Study
A NA study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 225
- Enrollment target
NCT01980485 is a NA study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 225 participants.
The verdict
NCT01980485, a NA study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 225 participants
- Enrollment target
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
Interventions
- BEHAVIORAL Lung Age feedback and exhaled carbon monoxide
- BEHAVIORAL No Lung Age Feedback
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01980485
The ClinicalTrials.gov registry entry for NCT01980485 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lung Age feedback and exhaled carbon monoxide is the first listed.
NCT01980485 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01980485 about?
NCT01980485 is a clinical study titled "The Get Quit - Stay Quit Study". 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 ev...
What is the current status of trial NCT01980485?
This trial is currently completed. It is a NA study. The enrollment target is 225 participants. The study started on 2012-01. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01980485?
The interventions under investigation include: Lung Age feedback and exhaled carbon monoxide (BEHAVIORAL), No Lung Age Feedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT01980485?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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