Relapse after a serious quit attempt occurs in 70-90% of smokers who try to quit smoking.
This study utilizes a sequential, multiple assignment, randomized trial (SMART) design - - an
innovative multi-phase approach - - to test post-relapse treatments designed to assist
smokers to make a new, successful quit attempt. This study will test Relapse Recovery (RR)
treatments that are applied at two stages following relapse: 1) RR Preparation Phase
treatments for smokers who relapse after an initial quit attempt, and 2) RR Cessation Phase
treatments for relapsed smokers who decide to make a new quit attempt. Smokers motivated to
quit smoking will make an initial quit attempt in the Quit Phase (cessation medication +
counseling). Participants who relapse will be randomized to one of three RR Preparation Phase
treatments (Behavioral [Smoking] Reduction Counseling + the Nicotine Mini-Lozenge; Recycling
Counseling that encourages participants to quit again as soon as possible; and Preparation
Phase Control). RR Preparation Phase participants (other than controls) who elect to try a
new quit attempt will be randomized to one of four RR Cessation Phase treatments based on a
2X2 fully-crossed factorial design testing two factors: Supportive Counseling (vs. Brief
Information) and Skill Training (vs. Brief Information). All RR Cessation Phase participants
will receive 8 weeks of combination nicotine replacement therapy (nicotine patch + nicotine
mini-lozenge). The investigators hypothesize that RR Preparation Phase Reduction treatment
will significantly increase long-term abstinence rates relative to the Preparation Phase
Control condition.
Phase:
Phase 4
Details
Lead Sponsor:
University of Wisconsin, Madison
Collaborators:
Penn State University University of Illinois at Chicago