None listed
Conditions
Brief summary
Increasing attention has been given to the concept of very low nicotine content (VLNC) as a mean to help individuals quit smoking or reduce the harm from smoking. Although not safer than normal cigarettes, VLNC could dramatically improve public health by reducing the prevalence of smoking if they assist people to quit smoking. The viability of VLNC as a smoking cessation strategy hinges in part on their acceptability and the willingness of smokers to use them. Although our RELIQ trial found that users reduced their total number of cigarettes smoked, smoking satisfaction appeared low, with smokers disliking the taste of the VLNC. Since the publication of the RELIQ trial, a new type of VLNC cigarettes has become available, one with a charcoal filter that tobacco companies claim are far more acceptable to consumers than previous products, and therefore more likely to be used as part of an attempt to quit tobacco altogether. To assess the acceptability, psychological reward, craving reduction, and physical and sensory effects experienced when smoking a newly developed brand of Very Low Nicotine Cigarette (VLNC; MAGIC 0), in comparison to smoking a previously developed brand VLNC (MAGIC).
Interventions
Test products, dosages and route of administration
Very low nicotine cigarette MAGIC 0, crafted with carbon filter (Federal Trade Commission [FTC] nicotine yield per cigarette = 0.04mg, FTC tar yield per cigarette = 4.1 mg, 22nd Century Group, Inc).
This brand of VLNC (called MAGIC 0), manufactured by 22nd Century Group, Inc, has recently became available on the Europe market (although they are not available in New Zealand). Similar to the previously developed MAGIC, MAGIC 0 cigarettes yield
Test products, dosages and route of administration Very low nicotine cigarette MAGIC 0, crafted with carbon filter (Federal Trade Commission [FTC] nicotine yield per cigarette = 0.04mg, FTC tar yield per cigarette = 4.1 mg, 22nd Century Group, Inc). This brand of VLNC (called MAGIC 0), manufactured by 22nd Century Group, Inc, has recently became available on the Europe market (although they are not available in New Zealand). Similar to the previously developed MAGIC, MAGIC 0 cigarettes yield only 0.04 mg nicotine per cigarette – 95% less nicotine than conventional cigarette brands. It has been claimed that the proprietary tobacco used in MAGIC 0 cigarettes has the taste of a conventional cigarette, but with lower-addictive levels of nicotine. According to the company, the addition of a carbon filter reduces toxic compounds in the smoke, and provides a full air flow smoking experience, making it different from previous products (e.g., MAGIC). Each participant will be allocated to smoke one MAGIC 0 and one MAGIC cigarette at the study site. Participant will smoke each cigarette as closely as possible to their normal smoking pattern. After smoking each cigarette participants will be given a 45 minute washout period in order to complete the evaluation questionnaire and to allow most of the inhaled nicotine to be metabolised (nicotine has a half-life in plasma of nine minutes). Reference therapy Very low nicotine cigarette MAGIC (FTC nicotine yield per cigarette = 0.04mg, FTC tar yield per cigarette = 4.1 mg, 22nd Century Group, Inc).
Sponsors
National Institute for Health Innovation, University of Auckland
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants will be eligible for inclusion in the study if they: are daily smokers of non-menthol tobacco cigarettes are willing and able to attend the study site for the entire duration of the study; are at least 18 years of age; have their first cigarette within 30 minutes of waking; self-report being in good health; are able to give written consent; are able to read and write English.
Exclusion criteria
Participants must not be currently using any form of smoking cessation therapy (e.g. NRT, buproprion [Zyban], clonidine, nortriptyline or vareniciline [Champix]) or be currently enrolled in a smoking cessation programme or cessation study. Pregnant women and women who are breastfeeding will be excluded from the study.
Outcome results
None listed