The Long-Term Quitting (Smoking Cessation) Study

Summary

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.

Timeline

Start

2015-10-30

Primary completion

2019-11-05

Completion

2019-11-05

Publications

• Schlam TR, Baker TB, Piper ME, Cook JW, Smith SS, Zwaga D, Jorenby DE, Almirall D, Bolt DM, Collins LM, Mermelstein R, Fiore MC. What to do after smoking relapse? A sequential multiple assignment randomized trial of chronic care smoking treatments. Addiction. 2024 May;119(5):898-914. doi: 10.1111/add.16428. Epub 2024 Jan 28.

Drugs

Indications

No indication recorded.