Facilitating smoking cessation using reduced nicotine cigarettes: Intervention development and RCT study design

Smoking cigarettes with substantially lower nicotine than conventional cigarettes prior to a quit attempt may reduce the reinforcing effects of smoking, which could facilitate smoking cessation through extinction learning. This paper describes the development of a smoking cessation intervention designed to optimize extinction processes using reduced nicotine cigarettes, as well as the design and methods for an ongoing randomized controlled trial (RCT) to evaluate this intervention. Qualitative methods and pilot testing were conducted to develop the novel facilitated extinction (FE) intervention, with a key focus on maximizing opportunities for extinction learning during a five-week pre-quit period. The primary aims of the RCT are to test the effects of the FE intervention versus a standard (cognitive-behavioral) intervention, while also comparing two nicotine reduction schedules for providing very low nicotine content (VLNC) cigarettes. The efficacy of the intervention is currently being evaluated with treatment-seeking smokers (n = 208) randomly assigned to one of four conditions crossing FE versus standard intervention with immediate versus gradual transition to VLNC cigarettes.