In March of this year, the FDA announced that they were considering setting a standard
for a maximum nicotine level in cigarettes to make them minimally addictive or nonaddictive.
JAMA this week is publishing a clinical trial comparing two different approaches the FDA is
considering for implementing reduced nicotine cigarettes.
T he first approach reduces nicotine levels in cigarettes immediately,
which might cause a significant number of smokers to experience withdrawal symptoms
and seek nicotine from other sources.
The second reduces nicotine levels gradually, which might result in prolonged exposure
to smoke toxicants, compensatory smoking during the early stages of nicotine reduction,
and similar or even lower smoking cessation rates.
The objective of this study was to compare the two approaches
to assess differences in biomarkers of smoke exposure.
Researchers conducted a randomized trial at 10 sites across the US.
The participants were volunteers, who were daily smokers
with no intention to quit within 30 days.
They had a mean age of 45 years.
701 were men, 549 were women.
After 2 weeks of baseline smoking, the 1250 participants were randomized to three groups.
The first group smoked lower nicotine cigarettes for 20 weeks,
where the nicotine was immediately reduced
from the standard 15.5 mg to 0.4 mg per gram of tobacco.
The second group also smoked lower nicotine cigarettes for 20 weeks,
but the nicotine was gradually reduced every 4 weeks over the trial period
from 15.5 mg to 0.4 mg per gram of tobacco.
The third, or maintenance group, continued smoking standard cigarettes
with 15.5 mg of nicotine per gram of tobacco.
The primary outcome was between-group differences in biomarkers of smoke exposure
over the 20 weeks of intervention.
The biomarkers were: -breath carbon monoxide -Urine phenanthrene tetraol,
an indicator of exposure to polycyclic aromatic hydrocarbons -and 3-HPMA,
a volatile organic compound metabolite.
Secondary outcomes included smoking behaviors like cigarettes smoked per day,
number of cigarette-free days, and survey measures of nicotine dependence.
Let's review the results.
958 of the 1250 participants completed the trial.
Lower levels of exposure were observed for all three biomarkers
in the immediate nicotine reduction group compared
with the gradual nicotine reduction group.
Lower levels of exposure were also observed in the immediate nicotine reduction group compared
with the control group for all three biomarkers.
But no statistically significant differences were observed
between the gradual reduction group and the control group for any of the biomarkers.
In terms of the secondary outcomes, participants
in the immediate nicotine reduction group had fewer total cigarettes per day,
a higher mean number of cigarette-free days, and lower measures of nicotine dependence compared
with those in the gradual nicotine reduction group.
The authors conclude that immediate reduction in nicotine content
of cigarettes provided the greatest reduction in biomarkers of smoke exposure over time,
and a reduction of cigarette consumption.
However, they also note that immediate reduction in nicotine caused greater withdrawal symptoms,
greater use of nonstudy cigarettes, and higher drop-out rates.
One last thing.
Our open access journal, JAMA Network Open, recently published a study looking
at how smoking reduced-nicotine cigarettes affects smoking behaviors.
The results of that trial also demonstrated that replacing standard cigarettes
with reduced-nicotine cigarettes did not lead to an increase in smoking or exposure
to the toxic components of cigarette smoke.
The link to that study is in the description below.