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BACKGROUND: This clinical experiment tested the effects of exposure to e-cigarettes with WS-23 or menthol cooling additives on user appeal and sensory attributes, and, secondarily, whether WS-23 effects generalised across base characterising flavour, nicotine concentration, or nicotine/tobacco product use status. METHODS: In this within-participant double-blind experiment, adult tobacco/nicotine users administered standardised puffs of 18 different e-cigarette solutions in randomised sequences using a pod-style device. Each of three base characterising e-cigarette flavour solutions ('bold tobacco', 'mango,' 'wintergreen') in both 2% and 4% concentrations of nicotine benzoate salt were manipulated by adding either: (1) Menthol (0.5%), (2) WS-23 (0.75%) or (3) No cooling agent. After each administration, participants rated 3 appeal and 5 sensory attributes (0-100 scales). RESULTS: Participants (n=84; M(SD)=38.6 (13.6) years old) were either exclusive e-cigarette (25.0%), cigarette (36.9%) or dual (38.1%) users. WS-23 versus no coolant products produced higher liking, willingness to use again, smoothness, and coolness and lower disliking, bitterness, and harshness ratings (|B|difference range: 4.8 to 20.1; ps<0.005). Menthol (vs no coolant) increased willingness to use again and reduced harshness and coolness (ps<0.05). Flavours with WS-23 (vs menthol) were rated as smoother, cooler and less harsh (ps<0.05). Coolant effects did not differ by base flavour, nicotine concentration, or tobacco use status. CONCLUSIONS: Adding synthetic coolant WS-23 to e-cigarettes appears to make the vaping user experience more appealing, regardless of characterising base flavour. Regulatory agencies should be aware that the manufacturing process of adding synthetic coolants may increase the attractiveness of various e-cigarette products.Cite Now.
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Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI) are debilitating diseases that affect millions of individuals and have notoriously limited treatment options. One emerging therapy, non-invasive 40 Hz sensory therapy delivered through light and sound has previously shown promise in improving cognition in Alzheimer Disease (AD) rodent models. Small studies in humans have proven safe and tolerable, however exploration of feasibility and utility is limited. The purpose of this study is to examine the feasibility of this treatment in a human population through a smart tablet application that emits light and sound waves at 40 Hz to the user over the span of 1 h a day. Confirmation of entrainment of 40 Hz stimulation in the cerebral cortex was performed via EEG. 27 preliminary subjects with subjective cognitive complaints, Mild Cognitive Impairment, or AD were enrolled in the study; 11 participants completed 6 months of therapy. Of those that discontinued treatment, other health issues and difficulties with compliance were the most common causes. Participants were followed with Montreal Cognitive Assessment (MOCA) and Boston Cognitive Assessment (BOCA). For participants with subjective cognitive complaints, 2 of the 4 had improved MOCA score and 1 of 4 had improved BOCA score. For the participant with MCI, his MOCA score improved. For AD participants, 2 out of 6 had improved MOCA score and 3 of the 6 stayed stable, while 3 of 6 BOCA score improved. 4 of 11 participants specifically increased their MOCA scores in the Memory Index section. Of the 8 participants/caregivers able to speak to perceived usefulness of the study, 6 spoke to at least some level of benefit. Of these 6, 2 enrolled with subjective cognitive complaint, 1 had MCI, and 3 had AD. The therapy did not have reported side effects. However, those who did not finish the study experienced issues obtaining and operating a smart tablet independently as well as complying with the therapy. Overall, further exploration of this treatment modalities efficacy is warranted.
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OBJECTIVES: Various organic acids are used to create nicotine salt formulations, which may improve the appeal and sensory experience of vaping electronic cigarettes (e-cigarettes). This clinical experiment examined the effects of partially and highly protonated forms of two nicotine salt formulations (nicotine lactate and benzoate) versus free-base (no acid additive) on the appeal and sensory attributes of e-cigarettes. METHODS: Current adult tobacco product users (n=116) participated in an online remote double-blind within-subject randomised experiment involving standardised self-administration of e-cigarette solutions varying in nicotine formulation (free-base, 50% nicotine lactate -1:2 lactic acid to nicotine molar ratio, 100% nicotine lactate - 1:1 ratio, 50% nicotine benzoate and 100% nicotine benzoate). Each formulation had equivalent nicotine concentrations (27.0-33.0 mg/mL) and was administered in four flavours in a pod-style device. After each administration, participants rated appeal (liking, disliking and willingness to use again) and sensory attributes (0-100 scale). RESULTS: Compared with free-base nicotine, 50% and 100% nicotine lactate and benzoate yielded higher appeal, smoothness and sweetness and lower harshness and bitterness. Dose-response analyses found 100% vs 50% nicotine salt improved appeal, smoothness, bitterness and harshness for nicotine lactate and sweetness, smoothness and harshness for nicotine benzoate. Solutions with higher pH were associated with worse appeal and sensory attributes across nicotine formulations. Nicotine formulation effects did not differ by tobacco use status and flavours. CONCLUSION: Restricting benzoic acid or lactic acid additives or setting minimal pHs in e-cigarettes merits consideration in regulations designed to reduce vaping among populations deterred from using e-cigarettes with aversive sensory properties. TRIAL REGISTRATION NUMBER: This study was registered under ClinicalTrials.gov Identifier: NCT03742817 under the title 'Effects of e-Cigarettes on Perceptions and Behavior'.