1. Free mailed nicotine patches, without behavioral support, resulted in improved self-reported smoking cessation at 6-months amongst a group of people interested in quitting smoking with nicotine replacement therapy compared to a similar group that did not receive any patches.
2. However, biochemical validation of smoking cessation was not significantly different between the two groups, although quality of saliva samples may have been poor.
Evidence Rating Level: 1 (Excellent)
Study Rundown: There has been evidence in clinical trials that nicotine replacement therapy (NRT) can improve rates of smoking cessation. However, it is unclear if this success can translate into real-world settings given the limited randomized trial data. This study aimed to evaluate the effect of mailing free nicotine patches to smokers interested in quitting without behavioral support on rates of smoking abstinence.
Self-reported rates of smoking abstinence were significantly higher in the group that received nicotine patches as compared to participants that did not. Biochemical validation of abstinence was difficult to interpret since about one-quarter of returned samples evaporated, which questioned the validity of the remaining samples. However, when analyzed, there was no significant difference between the saliva samples provided by the nicotine patch group or control group. Strengths of this study include using a nationwide sample, albeit in a single nation. However, lack of acceptable biochemical validation methods limited the ability to interpret the accuracy of these self reported claims of smoking abstinence.
Relevant Reading: Long-term Nicotine Replacement Therapy: a Randomized Controlled Trial
In-Depth [randomized controlled trial]: This single-blinded, 2-group randomized controlled trial was conducted across Canada from June 2012 to June 2014. Adult smokers were recruited using random-digit dialing of home and cell phone numbers and were assigned to either receive a 5-week supply of nicotine patches by mail (experimental group) or receive nothing (control group). The control group was unaware that nicotine patches were offered to the experimental group. All participants were followed with telephone interviews at 8-weeks and 6-months to determine the primary outcome of 30-day smoking abstinence at 6-months.They were also asked to provide saliva samples which were used to biochemically validate smoking abstinence. Statistical analysis included intention-to-treat approach with logistic regression.
A total of 2093 participants were interviewed at baseline and subsequently 1000 were eligible for randomization. Self reported rates of 30-day smoking cessation at 6-months were significantly higher in the NRT group (OR 2.65; 95% CI, 1.44-4.89; P=0.002). Just under 70% of participants claiming abstinence returned a saliva sample. Unfortunately, due to saliva evaporation, only 50.9% of abstinent participants’ saliva samples were biochemically analyzed. No significant difference was found between groups from this data. Given that 27% of initial samples evaporated, the validity of the analyzed samples was questionable and hindered interpretation.
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