Smokers wearing a 21 milligram (mg)
nicotine patch 24 hours a day experience superior relief of craving and
withdrawal when quitting when compared to smokers wearing a 15 mg patch for 16
hours, according to a study in the August issue of Addiction.
"The 24-hour nicotine patch enabled smokers to control their cravings and
some withdrawal symptoms more effectively during their first two weeks of
abstinence," says the lead study author Saul Shiffman, Ph.D., professor of
psychology at the University of Pittsburgh. "Those first two weeks of
quitting are crucial, because during this time symptoms usually are at their
peak and relapse is most likely."
The study, supported by a grant from SmithKline Beecham Consumer
Healthcare, compared a nicotine patch designed for 24-hour wear with one
designed for 16-hour wear for relief of craving and withdrawal, particularly
in the morning hours. The patches used in the three-week study were the two
brands approved for over-the-counter (OTC) sale in the United States: the 21
mg NicoDerm(R) CQ(R) patch and the 15 mg Nicotrol(R) patch. The 21 mg
NicoDerm CQ patch provides a constant supply of nicotine, even while smokers
sleep and when they first awaken, which protects them against morning craving.
In comparison, the 15 mg Nicotrol patch is recommended for use only during the
"waking hours" of the day (hence the 16-hour designation), to mimic the
pattern of nicotine intake and clearance smokers experience.
In the study, researchers enrolled 244 people aged 18 to 65 who had smoked
for at least three years and wanted to quit. All of the participants smoked
15 or more cigarettes daily and suffered from morning cravings. They were
randomly assigned to either a 16-hour or 24-hour patch. Participants wore two
patches during the day, one active, one placebo, and one patch while sleeping:
active for the 24-hour group, placebo for the 16-hour group. They also
received moderate behavioral counseling.
For a week of baseline and two weeks after quitting, participants used
palm top computers known as "patient experience diaries," which were used to
capture their experience in real-time, real-world settings. Eight to ten
times each day, the patient experience diary prompted participants to assess
their current craving and withdrawal symptoms. Participants also used the
diary to record episodes of when they felt tempted to smoke. This intensive,
real-time evaluation yielded detailed profiles of craving and withdrawal
experience, which for the first time enabled sensitive comparison of the two
patches. The patient experience diary also prompted participants to apply and
remove patches at appropriate times and to confirm that they had done so.
Analysis of the study data revealed that the 24-hour NicoDerm CQ patch was
more effective in lowering craving intensity and frequency than the 16-hour
Nicotrol patch. The 24-hour dosing cut craving intensity substantially vs.
dosing with the 16-hour patch (e.g., 2.7 vs. 4.1 in days 1-3 of quitting).
Additionally, the 24-hour patch cut at least by one-third the time that
participants experienced craving (e.g., 13% vs. 20% of waking hours in days
1-3 of quitting).
"Our study showed that NicoDerm CQ yields better symptom control in the
morning when smokers on Nicotrol would have very little nicotine in their
bodies. Also, NicoDerm CQ's effects extended throughout the day. NicoDerm
CQ's good control of symptoms early in the day could get smokers 'off to a
good start,' reducing their craving and withdrawal throughout the day,"
When compared to the 16-hour dosing Nicotrol patch, NicoDerm CQ also
helped lower the numbers of temptations smokers experienced (e.g., 2.4 vs. 4.5
over the first 3 days of quitting), while reducing some of the most common
withdrawal symptoms many smokers endure, including anxiety, irritability and
SmithKline Beecham originated the OTC nicotine replacement therapy
category with the FDA approval of over-the-counter Nicorette nicotine gum and
continues to lead the market after the introduction of the original
over-the-counter NicoDerm CQ nicotine patch and the launch of over-the-counter
Nicorette Mint and Clear NicoDerm CQ.