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: 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.

Keywords: Cigarette smoking; harm reduction; nicotine dependence; reduction; tobacco regulatory policy; very low nicotine content cigarettes.

Conflict of interest statement

Declaration of Interests: EMK, PWC, JAB, and NEM have nothing to disclose. JRH has received consulting and speaking fees from several companies that develop or market pharmacological and behavioral treatments for smoking cessation or harm reduction and from several non-profit organizations that promote tobacco control. He also consults for Altria, Philip Morris and Swedish Match on their harm reduction products.

© 2019 Society for the Study of Addiction.

Figures

Figure 1:. Participant flow diagram.

CPD=Condition that reduced cigarettes/day; DSM-5=Diagnostic and Statistical Manual of Mental Disorders Fifth Edition; NRT=Nicotine replacement therapy; TCORS=Tobacco Center on Regulatory Science; VLNC=Condition that switched to very low nicotine content cigarettes.

Figure 2:. Dependence outcomes.

aPost-hoc between-condition t-tests at week 4; CPD=Condition that reduced cigarettes/day; NDSS=Nicotine Dependence Syndrome Scale; nic=Nicotine; VLNC=Condition that smoked low nicotine cigarettes. The presented values are estimated marginal means from the mixed model.

Figure 3:. Acceptability and Nicotine Exposure Outcomes.

aSee Figure S2 for daily change; bSignificant post-hoc between-condition t-tests at each week; CPD=Condition that reduced cigarettes/day; nic=Nicotine; VLNC=Condition that smoked low nicotine cigarettes. The presented values are estimated marginal means from the mixed model.