Is Nicotine Replacement Therapy Effective?

Study Questions:

What is the efficacy of providing free nicotine replacement therapy (NRT) in the form of nicotine patch without behavioral assistance to smokers interested in receiving it?


This was a single-blinded, two-group randomized clinical trial comparing a control group with an experimental group receiving nicotine patches by mail. An initial screening interview identified adult smokers who smoked 10 or more cigarettes per day. Individuals who were hypothetically interested in receiving nicotine patches by mail to quit smoking were eligible for randomization. Participants in the experimental group were sent a 5-week course of nicotine patches by expedited postal mail. Participants randomized to the control group were not offered the nicotine patches or any other intervention. The primary outcome was 30-day smoking abstinence at 6 months. All participants were followed up at 8 weeks and 6 months by telephone. Biochemical validation was assessed with a saliva sample collection kit that patients were sent before the 8-week and 6-month follow-ups.


A total of 1,000 participants were randomized. One-half (50.9%) of the participants had usable saliva samples for biochemical validation. Participants receiving nicotine patches were significantly more likely to have verified abstinence at 6-month follow-up (14 [2.8%] of 500 in the experimental group vs. 5 [1.0%] of 499 in the control group; odds ratio [OR], 2.85; 95% confidence interval [CI], 1.02-7.96; p = 0.046). Participants receiving nicotine patches were significantly more likely to report abstinence at 6 months (38 [7.6%] of 500 vs. 15 [3.0%] of 499; OR, 2.65; 95% CI, 1.44-4.89; p = 0.002) and 8 weeks (37 [7.4%] of 500 vs. 11 [2.2%] of 499; OR, 3.55; 95% CI, 1.79-7.03; p < 0.001) compared with the control group.


Among adult smokers interested in receiving nicotine replacement, the provision of a 5-week supply of nicotine patches via mail (without any behavioral support or tobacco cessation counseling) and compared to no intervention at all led to a significant reduction in self-reported 30-day quit rates.


By conducting a randomized trial of NRT among adults interested in receiving such therapy and doing so without behavioral assistance, the authors provide evidence of the effectiveness of nicotine patches as a tobacco cessation aid. As the authors opine, ‘The results of the trial provide general support for direct-to-smoker programs with free mailed nicotine patches.’ Future studies are needed to further validate and refine this approach.

Clinical Topics: Prevention, Smoking

Keywords: Counseling, Nicotine, Primary Prevention, Self Report, Smoke, Smoking, Tobacco Use Cessation, Tobacco Use Cessation Products

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