SCIENTIFIC BACKGROUND PAPER:
Safety & Gateway Theories of Cigarette Alternatives
In studies on the facets of smoking that reinforce habitual cigarette use, it has been found that nicotine, though important as a pharmacological “reward” that is in itself addictive, is not the only feature of smoking that contributes to persistence of the habit and to relief of craving for cigarettes. Nicotine is the primary addictive substance in cigarette smoke, but it is not the only or primary determinant of habitual smoking, as is apparent from the observation that nicotine replacement therapies have not been very successful in helping people to quit smoking.
Tactile, sensory, and social elements of smoking all contribute to persistence of the habit, but a particularly significant contributor to immediate relief of craving is the airway sensation or “throat hit” during smoke inhalation. Smokers given de-nicotinized cigarettes, which maintain much of the sensory effect of complete cigarettes, in a controlled clinical setting continue to smoke them, with demonstrable relief from acute cigarette craving. In such clinical studies, de-nicotinized cigarettes can be more effective than nicotine replacement (including direct intravenous injections of nicotine) for immediate relief of craving for a cigarette, and combination of nicotine replacement (via a patch or gum containing nicotine) used with the sensations provided by a nicotine-free cigarette are more effective than either alone. An important point is that de-nicotinized cigarettes provide acute relief from the negative sensation of craving, but they do not provide the crucial positive “reward” caused by nicotine’s actions in the brain. The idea is that decoupling of nicotine and the sensory/tactile aspects of smoking is to gradually reduce the nicotine component of the pharmacological reward of smoking to serve cessation efforts, but nicotine-free cigarettes deliver many or most of the carcinogens, carbon monoxide and other toxic combustion products provided by standard cigarettes, and cannot be used in places where smoking is prohibited.
The observation that sensory, tactile and social aspects of cigarette smoking are significant contributors to the persistence of cigarette smoking habits provides an important opportunity for intervention. Novus, a new product from Sentiens, is a non-combusting, non-heating cigarette alternative that delivers airway sensations and aromas similar to a cigarette, but without any of the carcinogens, toxins, or carbon monoxide provided by cigarettes.
Novus is a paper rod the size and shape of a cigarette, treated with extracts made from spices that are used daily by millions of people as seasonings for foods. When puffed like a cigarette, even though no combustion or heating takes place, Novus delivers minute quantities of volatile spice constituents (far less than would be in foods seasoned with the original spices), sufficient to create sensations in the airway mimicking cigarette smoke, without any nicotine or tobacco toxins, carcinogens or carbon monoxide or other combustion products.
Novus is a tool for immediate reduction of craving, for situations where a smoker is not permitted to light up a cigarette or for supporting efforts toward cessation or reduction of cigarette usage. Like the de-nicotinized cigarette, Novus provides mimicry of tactile, sensory and potentially social aspects of smoking for acute relief of craving, though it has none of the inherent toxicity of a cigarette, with or without nicotine. However, because Novus does not deliver nicotine or any other substances into the brain, acting instead on sensitive sensory nerves in the throat by delivering an aerosol of minute quantities of volatile spice constituents, it will not provide the pharmacological “reward” that is crucial for promotion of true addiction. The positive sensations that may accompany use of Novus, and thereby support its use as an alternative to lighting a cigarette, are physiologically more like enjoyment of hot sauce or a spicy corn chip, rather than anything like an addictive pharmacological effect in the brain.
The experience documented in clinical literature is that sensory cues associated with smoking (including mimicry by Novus) acutely relieve negative affect associated with cigarette craving, but do not provide the direct effects of nicotine in the brain that mediate “positive” or rewarding effects of cigarettes that act as an unconditioned element supporting addiction. The decoupling of conditioned sensory, tactile and social elements of cigarette smoking from the effects of nicotine in the brain is the key to extinguishing the addictive component over time. Short of complete cessation, sufficient relief of craving to help someone cut down on the frequency of cigarette use provides a net benefit to their health. Similarly, relief of the negative symptoms associated with cigarette craving by Novus in situations where smoking per se is not possible should provide improved (or less distracted) functional performance of important or assigned tasks.
The published findings of clinical trial results on cigarette alternatives that provide at least some sensory cues but with no or reduced nicotine delivery should be applicable to Novus, and will be verified in planned clinical studies with Novus. That basic finding is that sensory substitutes or de-nicotinized cigarettes can relieve craving symptoms, but do not provide the central nervous system effects of nicotine that are critical for development of addiction. A critical component of addiction is the negative affect or other symptoms associated with withdrawal or deprivation of the addictive agent, not simply a pleasing sensation that one may wish to repeat occasionally. The physiology of Novus’ effects is essentially the same as wasabi in sushi or horseradish or hot sauce. Such spices can provide positive experiences that someone may wish to repeat, but in no way can be said to constitute true addiction with profoundly negative withdrawal symptoms.
The ingredients in Novus are all extracted from spices used in foods by literally millions of people on a daily basis for hundreds of years. This selection of widely-used dietary spices as the only sources of Novus ingredients inherently excludes anything that may commonly provoke allergic or hypersensitivity reactions in people. Furthermore, true allergens in foods are generally proteins. The active sensory agents in Novus are extracted into ethanol under conditions will denature any proteins that might be present. The amount of ethanol remaining in a puff of Novus that accompanies the spice constituents is less than 1/1000 the amount in a glass of beer, comparable to the amount of ethanol naturally present in a bite of yogurt or a slice of freshly-baked bread or any other fermented or cultured food.
An important demographic for Novus is experienced or habitual cigarette smokers who have become accustomed to the harshness of cigarette smoke and its toxic constituents in the throat. The effect of Novus as a sensory mimic of the throat and airway sensation of cigarette smoke is truly of the nature of a spice sensation, such as using wasabi with sushi, or a dash of hot sauce on a bite of food. The same classes of sensory receptors are involved; the only fundamental difference is that the spice extracts of Novus have been selected and combined to have less of an association with the flavors of common foods than these examples and greater similarity to the sensations evoked by inhalation of a cigarette. If a nonsmoker has a negative response to the sensation elicited by Novus, similar to what might happen when someone unaccustomed to spicy foods has some hot sauce, then that’s arguably a positive attribute, discouraging use by nonsmokers and perhaps serving as an aversive cue relative to their interest in cigarette smoking.
Gateway Theories for Alternative Cigarettes
The possibility that a cigarette mimic or alternative that could lead a user to move on to cigarettes themselves more readily than their simply starting to smoke cigarettes, while fitting into popular (though not necessarily well-supported) ideas about gateway or stepping-stone drugs in the context of substance abuse, is not born out by real-world observations with alternatives like electronic cigarettes or smokeless tobacco products. Such products do contain and deliver nicotine to the user, and are used as an alternative to cigarette smoking, and or as cigarette cessation aids. Habitual nicotine use is often or generally maintained with such devices, though with likely less risk than is associated with inhalation of tobacco smoke, as is born out by reduced incidences of lung disease in countries like Sweden, where smokeless tobaccos products are widely used as alternatives to cigarettes, versus nearby countries where smokeless tobacco is not widely available or used, such as the UK.
In the setting of smokers needing tools for support of cessation or reduction of cigarette use, an argument can be made that ideological discouragement from use of apparently safer alternatives may be a net detriment to public health, and such communications are based in part on unproved assertions about possible gateway use by young people. However, Novus is outside of such frameworks of concern altogether, in that it has no nicotine or any constituents whatsoever derived from tobacco, and does not involve heating or combustion at all.
References and Citations related to Sentiens technology can be found here