BACKGROUND: A national product standard restricting the nicotine content of smoked tobacco products to minimally addictive levels has been proposed in New Zealand and USA. This study aimed to assess the effect of switching to very low nicotine cigarettes (VLNCs) with access to electronic cigarettes (ecigs) with and without nicotine, in people with psychiatric disorders.
METHODS: 80 daily cigarette smokers were recruited at an academic medical center in USA. Participants were randomized, double-blind, to smoke either VLNCs or Normal Nicotine Cigarettes (NNCs), and to have access to either 5% or 0% nicotine ecigs for 16 weeks. Participants were followed for 16 weeks, and then again 4 weeks after the randomized phase. Cigarette consumption, adverse events and biomarkers of exposure (e.g. exhaled CO) were recorded. The hypothesis was that smokers randomized to VLNCs would reduce cigarette consumption, and this effect would be greater in those provided with 5% nicotine ecigs.
RESULTS: Sixty (75%) participants were women, the mean age was 47.71 (89%) were white and their mean baseline cigarette consumption was 20 per day. Participants had an average of 2 current psychiatric disorders. At week 16, participants randomized to VLNCs had a lower cigarette consumption than those given NNCs (10 v 19 per day, p<0.05), even after controlling for baseline variables. At week 16, significantly more of the VLNC group had quit smoking for at least the past week, validated by exhaled carbon-monoxide, (15% v 0%), and this was maintained at week 20. There were no significant effects of ecig randomization on cigarette consumption. Those randomized to VLNCs had fewer serious adverse events than those smoking NNCs.
CONCLUSIONS: A low nicotine standard for cigarettes may help smokers with psychiatric disorders to reduce and quit smoking without worsening mental health, regardless of access to nicotine ecigs.