Chronic Diseases Clinical Trial
Official title:
Longitudinal Care: Smoking Reduction to Aid Cessation; Part of Hatsukami's Tobacco Exposure Reduction
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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