Identifying Optimal Smoking Cessation Intervention Components (Cessation)
This trial is active, not recruiting.
|Conditions||smoking, smoking cessation, nicotine|
|Treatments||counseling before quit attempt, minimal in-person counseling during quit attempt, intensive in-person counseling during the quit attempt, minimal phone counseling during the quit attempt, intensive phone counseling during the quit attempt, long term nicotine patch+ nicotine gum during quit attempt, short term nicotine patch + nicotine gum during the quit attempt, pre-quit nicotine gum, pre-quit nicotine patch, pre-quit nicotine patch + pre-quit nicotine gum|
|Sponsor||University of Wisconsin, Madison|
|Collaborator||Dean Health System|
|Start date||June 2010|
|End date||May 2014|
|Trial size||637 participants|
|Trial identifier||NCT01116986, 9P50CA143188, H-2009-0204|
The goal of this research is to identify the best smoking cessation intervention components to be combined into a state-on-the-art, comprehensive smoking cessation intervention. This research examines the ability of different interventions, provided both prior to and after the quit attempt, to maximize the ability to initially quit and then stay quit. The investigators will be examining six different treatment interventions: pre-quit nicotine patch, pre-quit nicotine gum, pre-quit counseling, post-quit in-person counseling, post-quit phone counseling and duration of post-quit nicotine replacement therapy.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
|Masking||single blind (outcomes assessor)|
Latency to Relapse
time frame: During the first 6 months post-quit
7-day point prevalence abstinence
time frame: Assessed at weeks 8, 16, and 26 post-quit.
Male or female participants at least 18 years old.
- 18 years of age or older;
- Report smoking at least 5 cigarettes per day for the previous 6 months;
- Able to read and write English;
- Agree to attend visits, to respond to coaching calls, and to respond to Interactive Voice Response (IVR) phone prompts;
- Plans to remain in the intervention catchment area for at least 12 months;
- Currently interested in quitting smoking (defined as would like to try to quit in the next 30 days).
- All women of childbearing potential will be required to agree to use an acceptable method of birth control to prevent pregnancy during the study.
- Currently taking bupropion, Wellbutrin, chantix or varenicline (current use of NRT is not exclusionary if the participant agrees to use only study medication for the duration of the study);
- Study candidate is pregnant, trying to get pregnant, or nursing.
- A history of psychosis or bipolar disorder
- A history of skin or allergic reactions while using a nicotine patch.
- Had a heart attack, stroke, or abnormal electrocardiogram within the past 4 weeks.
|Official title||Project 2: Identifying Optimal Smoking Cessation Intervention Components|
|Principal investigator||Timothy B Baker, PhD|
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