Longitudinal Care: Smoking Reduction to Aid Cessation

• The primary endpoint will be 6M of abstinence measured 18M after enrollment. [ Time Frame: 18M ] [ Designated as safety issue: No ]
  6M prolonged abstinence
  
  

• 7d point prevalent abstinence [ Time Frame: 18M ] [ Designated as safety issue: No ]
  Data collected at 21d, 3, 6, 12, 18M
  
  
• 30d point prevalent abstinence [ Time Frame: 18M ] [ Designated as safety issue: No ]
  Data collected at 3, 6, 12, 18M
  
  
• Smoking reduction [ Time Frame: 18M ] [ Designated as safety issue: No ]
  Data collected at 3, 6, 12, 18M
  
  
• Total duration of abstinence [ Time Frame: 18M ] [ Designated as safety issue: No ]
  Time Line Follow Back
  
  

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.