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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
Author(s) -
Klemperer Elias M.,
Hughes John R.,
Callas Peter W.,
Benner Joy A.,
Morley Nicholas E.
Publication year - 2019
Publication title -
addiction
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.424
H-Index - 193
eISSN - 1360-0443
pISSN - 0965-2140
DOI - 10.1111/add.14666
Subject(s) - nicotine , nicotine patch , medicine , randomized controlled trial , smoking cessation , nicotine dependence , anesthesia , placebo , alternative medicine , pathology
Abstract Background and Aims The United States Food and Drug Administration has proposed regulation to require that 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. Design A two‐arm, individually randomized open‐label trial. Setting Community setting, Vermont, USA. Participants Sixty‐eight adult daily smokers (40% female) of ≥ 10 cigarettes/day who were not planning to quit in the next 30 days. Interventions All participants smoked study cigarettes with a nicotine yield similar to most commercial cigarettes ad libitum 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. Measurements The primary outcome was change in nicotine dependence assessed at baseline and weekly during the intervention with the Nicotine Dependence Syndrome Scale. Findings Dependence 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 = 0.018). Conclusions Transitioning 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.