Effectiveness of switching to very low nicotine content cigarettes plus nicotine patch versus reducing daily cigarette consumption plus nicotine patch to decrease dependence: An exploratory randomized trial.

Abstract

BACKGROUND AND AIMS\nThe United States Food and Drug Administration has proposed regulation to require cigarettes contain very low nicotine content (VLNC). In contrast, reducing the number of cigarettes per day (CPD) is the most common current method to reduce nicotine. This trial aims to explore whether gradually transitioning to VLNC cigarettes plus nicotine patch or reducing CPD plus nicotine patch is more effective at decreasing nicotine dependence.\n\n\nDESIGN\nA two-arm, individually randomized open label trial.\n\n\nSETTING\nCommunity setting, Vermont, USA PARTICIPANTS: 68 adult daily smokers (40% female) of ≥ 10 cigarettes/day who were not planning to quit in the next 30 days.\n\n\nINTERVENTIONS\nAll participants smoked study cigarettes with a nicotine yield similar to most commercial cigarettes ad lib for 1 week (baseline). Participants then gradually reduced to 70%, 35%, 15% and 3% of baseline nicotine over 4 weeks by either a) transitioning to lower nicotine content cigarettes (N=36) or b) reducing the number of full nicotine cigarettes (N=32). All participants received nicotine patches.\n\n\nMEASUREMENTS\nThe primary outcome was change in nicotine dependence assessed at baseline and weekly during the intervention with the Nicotine Dependence Syndrome Scale.\n\n\nFINDINGS\nDependence declined over time for both VLNC and CPD participants but declined more for VLNC (mean decrease in z-score of 1.0) than CPD (mean decrease in z-score of 0.5) participants over time (interaction p=.018).\n\n\nCONCLUSIONS\nTransitioning to very low nicotine content cigarettes reduced nicotine dependence over a 4-week period to a greater extent than reducing cigarettes per day when both conditions were aided by nicotine patch.