SCIENTIFIC BACKGROUND PAPER:

Novus Information for Healthcare Professionals

[This paper was written with the goal of answering questions that have been asked by Healthcare professionals – doctors, scientists, and others – as they consider if and how to participate with us on our general scientific studies and research]

Conventional approaches to smoking cessation are limited with questionable efficacy regarding abstinence. Over The Counter (OTC) nicotine replacement therapies (NRT) (i.e. nicotine gum, patches, inhalers) deliver nicotine to satisfy individual cravings with the likelihood of cessation only double that of placebo or no treatment at all according to recent meta-analysis [Odds Ratio (OR) 1.77, 95% CI] (Silagy, 2004). Psychotropic pharmaceuticals include antidepressants of varying classes with buproprion (Zyban) and varenicline (Chantix) being the primary drugs currently used. Bruproprion blocks the reuptake of dopamine and norepinephrine; while varenicline, a partial agonist of nicotinic acetylcholine receptors, is thought to inhibit the dopamine activation produced by smoking while lessening the craving associated with nicotine withdrawl. Neither drug is without side effects; the most significant being an increased risk for suicide. Moreover, the likelihood of cessation according to meta-analysis with buproprion is just double that of placebo (Hughes 2004). Three trials compared varenicline to brupropion and the OR favoring varenicline was 1.66 [95% CI] (Cahill, 2007).

Acupuncture and Hypnosis are the primary non-conventional modalities used in smoking cessation but little peer-reviewed literature exists to conclude efficacy and methodological flaws exist (White, 2006). E-cigarettes and smokeless tobacco products are alternative delivery systems for nicotine, neither intended for cessation or withdrawl and low nicotine cigarettes continue to deliver nicotine, carbon monoxide and carcinogens as well as other toxic byproducts of combustion, albeit at reduced loads. NOVUS is a unique smoking alternative. NOVUS is a physical and behavioral stimulus, utilizing afferent pharmacology to mirror the perceptual experience and cravings associated with smoking, without tobacco. We believe NOVUS will prove instrumental in aiding smoking cessation with continued abstinence.

NOVUS relies upon Chemosensation, a sensory system unique to the skin and mucosa; anatomically separate from taste and smell. Physical and chemical stimuli interact with somatosensory nerve endings of the trigeminal, glossopharyngeal and vagus nerves specifically, located in the mouth, nose and airway via direct gating of TRP ion channel receptors which induce changes in ionic permeability leading to depolarization and subsequent action potential formation resulting in afferent signaling to the CNS initiating sensations and reflexes ultimately evoking the perception of flavor, touch, temperature and pain (Rose & Hickman,1967) (Ginzel,1975). These nerve endings are activated by a wide range of stimuli but have evolved to especially favor plant derived chemicals, with built-in redundancy and exquisite sensitivity (i.e. response thresholds being 1-2 log units higher than olfactory thresholds for the very same compounds) (Bryant & Silver 2000). Chemosensory nerve fibers are less discriminatory compared to olfaction; evolving instead as a sentinel, to ward off irritants and potential danger. Thus, CNS- mediated reflexes encompassing protective responses such as sneezing, coughing, mucous secretion, salivation, tearing, bronchospasm and respiratory suppression are triggered by the delicious stimulation to some, of capsaicin in chili peppers for example, to the tasteless/odorless yet lethal carbon monoxide found in cigarette smoke. Additionally, activation of the same sensory nerve endings also trigger reflexes linked to learning and memory evoking feelings of pleasure or dissatisfaction as evidenced through food and cigarette cravings. In short, the very same chemoreceptors that are activated by nicotine and cigarette smoke are activated by the innocuous proprietary blend of herbs and spices found in NOVUS, in effect mimicking the chemosensory experiential effects of smoking minus the tar, nicotine, and other hazardous byproducts of combustion from smoking tobacco.

NOVUS uses organic, botanical herbs and spices from natural sources of berries, seeds, fruits, rhizomes, leaves and gum from tree bark, that have been safely consumed by people in food and used in the healing Whole Systems of Ayurvedic and Traditional Chinese Medicine for centuries. The botanicals used in NOVUS are dissolved in ETOH for suspension, creating a botanical tincture. Tinctures are alcoholic or hydroalcoholic solutions made from botanicals. The amount of tincture and/or ETOH in each twig is miniscule resulting in approximately 50 microliters per inhalation. This is a trace amount, far less than a single bite of ingested food and is further limited by room temperature volatility and the fact that vapor delivery activates sensory receptors with lower amounts of spice constituents than required by food-borne or liquid spice extracts (R. von Borstel, 2012). When the NOVUS twig is drawn upon, vaporization of the proprietary tincture of herbs and spices in “Botanic Boost” stimulate sensory receptors in the mouth and throat inducing autonomic reflexes contributing to the subjective experience of smoking referred to as “throat hit” by smokers. Throat hit alone often satisfies the craving for a cigarette-long before tar, nicotine and the other hazardous byproducts of combustion from smoking tobacco even have a chance to enter the bloodstream and later the brain leading to a cascade of neurological events ultimately resulting in addiction.

“Botanic Boost” was created with the intent to mimic and satisfy the subjective experience of smoking without actually smoking utilizing afferent pharmacology. The environment or social setting in which people smoke is another important piece of that subjective experience. These are the cues or rituals that often lead to relapse and why so many current smoking cessation aids fail to satisfy the smoker. The mere act of holding a cigarette can reduce the craving to smoke, even in the absence of nicotine (Siegal et al, 2011). With this in mind, the NOVUS “twig” was created to specifically look and feel like a cigarette from its outer paper to inner wrap, once again to satisfy the tactile piece of the subjective experience of smoking, so craved by smokers. Plus it is completely biodegradable. NOVUS is not lit nor is it smoked. NOVUS is not a cigarette. There is no tar, nicotine, tobacco or toxic byproducts. NOVUS has no significant side effects. NOVUS is not a drug nor is it a gateway to other drugs. NOVUS is a novel approach to provide the satisfaction similar to a cigarette in a safe, natural and healthy alternative. Nothing in Novus is known to be detrimental or addictive. Further, nothing in the Botanic Boost formula and the tactile modality of the Novus is known to have the potential of negative reactions if used as part of an integrative smoking cessation program. Rather, Novus can provide satisfaction from craving for a cigarette associated with the subjective experience of smoking. Novus has not been reviewed or tested as a drug and does not fall under any FDA regulatory policies.

Smoking cessation would be easy if it were a simple matter of detoxification and NRT’s would indeed be far more effective than placebo if that were the case. The story is instead complicated by maladaptive forms of learning and behaviors hijacked by nicotine itself, leading to false memories fueled by environmental cues and alterations in the structure of the brain itself (Malenka, 2006). In reality, smoking cessation thus requires a combination of integrative approaches ideally including some form of supportive therapy (individual or group) and should be tailored to the patients’ motivational state, belief system and personal story. One size does not fit all however and there are still some patients who can quit “cold turkey;” but even they are often plagued by false memories, the temptation of ritual and the desire to smoke. Smoking cessation, as with all addiction, diagnoses and most things in life, fall within a spectrum. Regardless of methodology, a sustained response is the long-term goal; not an immediate cessation or a “quick-fix” which no doubt will be short lived. Unfortunately an integrative approach is rarely followed; and as with all forms of addiction, relapse rates in smoking cessation are high. We believe our technological approach can be the missing link for smoking cessation. NOVUS utilizes a fundamental sensory system appearing central to nicotine addiction; a sensory system not only under- appreciated in smoking cessation but addiction medicine in general.

Please contact the scientific team at Sentiens LLC, if you are interested in working with us in clinical trials using our patent-pending technology as an adjuvant to your smoking cessation programs.