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SYM14C
A MULTI-SITE, DOUBLE-BLIND, RANDOMIZED TRIAL OF
CIGARETTES WITH REDUCED NICOTINE CONTENT
Regulated reduction of the nicotine content of cigarettes has the potential to
reduce cigarette reinforcement, dependence and toxicant exposure. However,
few clinical trials of very low nicotine content cigarettes have been conducted.
Furthermore, little or no data are available describing the relationship between
the level of nicotine in reduced nicotine cigarettes and critical outcome measures
such as smoking behavior, biomarkers of exposure, and safety. This presentation
will focus on the results of a recently completed 10-site clinical trial of the effects
of cigarettes with a wide range of nicotine contents (SPECTRUM cigarettes).
Following a baseline period, 840 smokers not seeking treatment were randomized
to smoke either their usual brand, one of five cigarettes with tar yields of 7.5-12
mg that varied in nicotine content (~0.4 mg/g to ~18.6 mg/g tobacco), or a low
nicotine content (~0.4 mg/g), high tar yield (11-15 mg) cigarette. Nicotine yields
(FTC) ranged from ~0.03 to 0.8 mg. More than 92% of randomized participants
completed the 6-week period of product use. At the end of 6 weeks, cigarettes
with ~2.5 mg/g or less nicotine (regardless of tar yield) resulted in fewer cigarettes
smoked per day relative to both usual brand and normal nicotine content cigarettes
(p<0.01). Urinary total nicotine equivalents (TNEs; analyzed in a subset of 343
participants) were related to the nicotine content. Cigarettes with ~1.3 mg/g or
less nicotine significantly reduced TNEs by approximately 60-80% (p<.001).
Intermediate nicotine content cigarettes (~5-6 mg/g nicotine) resulted in little
change in smoking behavior and more modest decreases in TNEs (p<.05). There
was little evidence of compensatory smoking as measured by increases in CO.
There were no related or possibly related serious adverse events. The presentation
will also address how nicotine content relates to compliance, retention, subjective
ratings of cigarettes, withdrawal and dependence. Together, these data provide strong evidence consistent with previous smaller trials that significant reductions
in nicotine content are likely to reduce smoking and nicotine exposure amongst
current users.
JUSTIFICATION: This study represents the largest clinical trial to date of a
potential policy to reduce nicotine content in cigarettes.
FUNDING: Research reported in this publication was supported by the National
Institute on Drug Abuse and FDA Center for Tobacco Products (CTP) (U54
DA031659). The funding source had no other role other than financial support.
The content is solely the responsibility of the authors and does not necessarily
represent the official views of the NIH or the Food and Drug Administration.
CORRESPONDING AUTHOR: Eric C. Donny, Department of Psychology, 3137
Sennott Square, 210 South Bouquet Street, University of Pittsburgh, Pittsburgh PA
15260 USA, edonny@pitt.edu
