Limitations of Nicotine Replacement Therapy Products

Approximately 1.6 billion people smoke worldwide; 44 million of those are in the U.S. Smoking accounts for 5.4 million deaths per year worldwide. The average smoker attempts to quit between 8 and 11 times.

Smokers feel the effects of nicotine within moments of their first inhalation, and the nicotine is maximized in the bloodstream within 8-10 minutes. When a smoker tries to quit, the body craves the nicotine, and he or she develops “smoker’s cravings.” The scientific literature on smoking cessation indicates that when a smoker’s cravings are not satisfied within 10 minutes, he or she has a greater chance of starting to smoke again, and their attempt to quit smoking will likely fail (Schneider, et al. (1996), Clin Pharmacokinet., 31(1): 65-80.)

Today’s Nicotine Replacement Therapy products (NRTs) such as gums, lozenges, and patches do not provide the immediate relief that smokers need, nor do they provide prolonged relief. When using a gum or lozenge, it can take 20-30 minutes before a smoker starts to feel relief from his or her craving, and it can take longer before maximum relief is felt. In addition, the relief can be short-lived, lasting only 30-40 minutes before another gum or lozenge is needed. The nicotine patch, on the other hand, is designed to provide sustained levels of nicotine in the bloodstream, but suffers from side effects 23% of the time, and users experience breakthrough cravings leading to relapse. The nicotine patch has a reported 8% efficacy rate at 24 weeks (Shiffman et al. (2001). Addiction, 97, 505-516; Hays et al. (1999). American Journal of Public Health, 89(11), 1701-1707.) It can be difficult to use many these products throughout the day, as they can cause side effects such as nausea, vomiting, jaw pain, and fatigue. Ultimately, smokers who use these traditional NRTs only succeed in quitting 3-8% of the time over the course of a year.

Nicotine sprays and inhalers address the need for quick craving relief, but the relief is not prolonged, and they have side effects. The recent success of e-cigarettes is related to their speed of onset, minimal associated side effects, and also a perceived but undocumented safety profile relative to cigarettes. Recently, high-voltage e-cigs have been associated with 5-15x the cancer risk of long-term smoking. E-cigarettes are also beset by second-hand vapor issues, are used widely by underage consumers, and seem to act as a gateway to cigarette use. For these reasons, e-cigarette use is being restricted nationwide in public areas by local governments.