An interventional study of smoking cessation in Chronic Diseases, sponsored by National Institutes of Health (NIH). Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-14.
Sponsored by National Institutes of Health (NIH) · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether an extended care treatment model lasting over a year will increase long-term smoking cessation rates compared to the standard 8 week treatment of care.
Objective The objective of this project is to conduct a randomized controlled trial to compare 1) an extended quality care smoking cessation treatment delivered over a one-year period (EQC) to 2) quality care smoking cessation treatment delivered over an 8 week period (QC) to determine if EQC improves prolonged smoking abstinence.
Research Design/Methodology 500 smokers who are interested in quitting will be enrolled and randomly assigned to the EQC or QC groups. Both groups will initially receive a state-of-the-science smoking cessation intervention including behavioral and pharmacological components, delivered by a combination of in-person and telephone care. EQC participants who fail to quit, reduce but do not quit, or relapse will receive intensive treatment over the ensuing 12 months that encourages repeat quit attempts and smoking reduction if they are not to quit. We propose reduction as an intermediate goal in LC because this may increase the likelihood of cessation, increase self-efficacy and keep smokers and clinicians engaged. Reduction treatment will include behavioral treatment and nicotine replacement. QC participants will only receive occasional prompts to quit. The primary endpoint will be 6M of abstinence measured 18M after enrollment. Secondary endpoints will include point prevalent abstinence, smoking reduction, self-efficacy and satisfaction. We will also collect qualitative data from successful abstainers and reducers about decision making processes and intervention experiences.
Clinical Significance This project will address the potential role of smoking reduction in the treatment menu for smokers interested in quitting. This project examines mechanisms, methods and a "real world" application for reducing toxin exposure.
990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.
This study's enrollment of 443 is above the median of 120 across 722 interventional studies indexed under Chronic Disease.
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Exclusion Criteria:
One year of combined behavioral and pharamcological tobacco dependence treatment, with interim smoking reduciton for smokers who fail initial quit attempt.
Behavioral: smoking cessation
Evidence based, state-of-the-science tobacco treatment; combined behavioral and pharmacological treatment for 8 weeks
Behavioral: smoking cessation
This was a randomized controlled trial to compare long-term smoking cessation outcomes between Longitudinal Care (LC) and Usual Care (UC) treatment groups. The LC group received smoking cessation treatment (combined behavioral and pharmacological therapies) for one-year period. This treatment recommended repeat quit attempts or smoking reduction for those who failed to quit after the initial attempt. The UC group received evidence-based treatment that lasted 8 weeks.
The primary endpoint will be 6M of abstinence measured 18M after enrollment.
6M prolonged abstinence
Time frame: 18M
7d point prevalent abstinence
Data collected at 21d, 3, 6, 12, 18M
Time frame: 18M
30d point prevalent abstinence
Data collected at 3, 6, 12, 18M
Time frame: 18M
Smoking reduction
Data collected at 3, 6, 12, 18M
Time frame: 18M
Total duration of abstinence
Time Line Follow Back
Time frame: 18M
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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National Institutes of Health (NIH)