As part of the ongoing research and testing of the science behind the products developed by Sentiens, the Company engaged a clinical research firm to test the satisfaction smokers felt from using BotanicBoost. There is a strong correlation identified from multiple peer reviewed research studies between smoker satisfaction, craving relief, and ultimately reduction or cessation. Thus the ability to prove efficacy in smoker satisfaction is a leading indicator to gauge the potential efficacy in reduction or cessation, before committing to the time and costs associated with these studies that are 12 months or longer across larger patient populations.
With issued patents on the core technology of BotanicBoost® and its use in simulating smoking, Sentiens began a formal clinical study to substantiate the positive and satisfying effects BotanicBoost® can have for smokers. These positive effects were previously highlighted in market research surveys performed by Sentiens. In an internal survey of consumers, over 71% who tried the Novus Twig® when they were craving a cigarette said that craving was reduced. The external clinical study was conducted by the Rose Research Center (RRC), which is led by Dr. Jed Rose, a luminary in the field and one of the original developers of the nicotine patch.
The research study was a randomized, double-blind, placebo-controlled, counterbalanced 2×2 design comparing the Sentiens BotanicBoost® product with placebo versions (without BotanicBoost®). The study was reviewed and approved by the Schulman Institutional Review Board (IRB). One of the delivery products was a heated device intended to deliver an aerosol of BotanicBoost, very similar to the eTwig by Novus. The other product is paper based and delivers BotanicBoost in an invisible vapor form, very similar to the Novus Twig.
Sixteen healthy, eligible, adult male and female current CC smokers were enrolled and asked to attend four laboratory sessions, all conducted after a one hour forced abstinence period from any tobacco/nicotine containing products. During the laboratory sessions subjects used either an active or placebo product for a maximum of three hours. Each subject tested both active and placebo of both delivery modalities in a random sequence over the course of their 4 visits. They also compared against their own brand of cigarette. The final results of this study provide third party clinical research data on BotanicBoost’s effectiveness, and support the prior marketing research done internally by Sentiens. In addition, the study provides data on safety and toxicity issues with subjects.
The study entitled “Evaluation of a Botanical Extract that Mimics the Respiratory Cues of Cigarette Smoke”, was published in the Journal of Smoking Cessation and can be accessed at www.cambridge.org/core/journals/journal-of-smoking-cessation. According to Rose Research, the satisfaction level of BotanicBoost® based products was greater than placebo at a statistically significant level. Further, the actual ratings compared equally or better than other products RRC has tested, including various e-cigarettes and other nicotine containing products for the industry. The researchers were surprised and impressed with the strong results especially in comparison to nicotine based products. Regarding the safety of BotanicBoost, they found no indications of any pulmonary or cardiovascular issues, or other adverse events. These results validate our own tests on both satisfaction and safety. They provide third party clinical research data on BotanicBoost’s effectiveness, and will be used to support future grant applications and intended FDA application in Phase 1. Below is an excerpt from a summary report of the results and conclusions.
Satisfaction ratings were significantly greater for the active eNovus (M=3.16, SD=1.05) than for the placebo eNovus (M=2.65 SD=1.20); t(15)=2.21, P=0.02. There was also a trend for the Novus (M=2.28, SD=1.43) to be rated higher than the Novus placebo (M=1.85, SD=1.23), with this comparison falling short of statistical significance; t(15)=1.70, P=0.06. No serious adverse events were observed, and there were no clinically significant changes in vital signs or pulmonary function associated with product use.
The active formulations of eNovus provided moderate levels of satisfaction to cigarette smokers, which were significantly higher than a flavored placebo. In a study of forty-one cigarette smokers using marketed nicotine-containing products for three days, Steinberg et al. (J Gen Int Med, published online 15 ay 2014; DOI: 10.1007/s11606-014-2889-7) reported mean satisfaction ratings of 5.0 for a popular brand of e-cigarette and 2.6 for the FDA-approved nicotine inhaler. Thus the eNovus and Novus products, despite the absence of nicotine, compared favorably with at least one marketed nicotine-containing product. The study results suggest that products containing BotanicBoost® might serve as effective substitutes for cigarette smoking, alone or in combination with other forms of nicotine replacement. Further studies will be needed to evaluate the acceptability of these products with longer-term use and potential efficacy in smoking cessation treatment.
Based on the positive results of this clinical study, Sentiens intends to continue to research the efficacy of BotanicBoost on craving alleviation and ultimately reduction or cessation of nicotine and smoking.
A copy of the final manuscript submitted for publication is available HERE.
 Rose, J., Willette, P., Loeback, T., & Botts, D. (2018). Evaluation of a Botanical Extract that Mimics the Respiratory Cues of Cigarette Smoke. Journal of Smoking Cessation, 1-6. doi:10.1017/jsc.2018.14