Study says nicotine patches effective without direct counseling

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Nearly 20 percent of smokers using an over-the-counter nicotine patch in a new study were able to quit smoking entirely after six weeks, compared to only 7 percent of smokers using a dummy patch. Each group reported only mild side effects from patch use, like rashes or insomnia.
None of the smokers received any direct instruction on how to use the patch or got behavioral counseling to help them quit smoking, which suggests that nicotine patches used in an over-the-counter manner can be safe and effective, say the study authors. The study was supported by GlaxoSmithKline Consumer Healthcare, which markets the NicoDerm CQ patch.

“Most smokers still try to quit without the benefit of treatment; their odds could be improved by the use of the nicotine patch,” says lead author Saul Shiffman, Ph.D., of Pinney Associates and the University of Pittsburgh and colleagues. “Our study suggests that over-the-counter nicotine patches can nearly triple a smoker’s chances of quitting.”

The study appears in the December issue of Nicotine & Tobacco Research.

Active nicotine patches benefited other smokers as well. 26.1 percent of active patch users had abstained from smoking for at least seven days before their six-week follow-up visit, compared to 7.7 percent of placebo patch users.

“This suggests that active treatment has not only helped smokers establish complete and continuous abstinence, but also may have helped smokers recover from lapses and re-establish abstinence,” say the researchers.

Most previous clinical trials of the patch’s effectiveness also involved forms of behavioral support like repeated medical visits and group meetings. Although the patches proved to be effective in these trials, researchers have wondered whether they would work as well in “real-life” over-the-counter conditions, where individuals buy and administer the patch without outside therapeutic support.

To test this scenario, Shiffman and colleagues randomly assigned half of 567 men and women enrolled in their study to receive an active nicotine patch while the other half received a fake patch that looked and smelled like the active patch but contained no nicotine. On average, the participants smoked 25 cigarettes a day and had been smoking for about 23 years.

The study was designed to mimic an “over-the-counter experience” as much as possible: Participants had no contact with staff except for their initial enrollment and their follow-up visit, and received only the same materials that are packaged with an over-the-counter patch.

The researchers also followed up with the participants after 10 weeks on the patch, at which point active patch users still had a higher percentage of complete abstinence and seven-day abstinence than placebo patch users.