Nicotine delivery, cardiovascular profile, and subjective effects of an oral tobacco product for smokers

Abstract

The tobacco industry markets potential reduced exposure products (PREPs) to smokers, including oral products that are intended to be used in situations where cigarettes cannot. For example, Ariva, marketed by Star Scientific, is a tablet made from compressed tobacco powder and is intended for "adult smokers in situations where they cannot or choose not to smoke." No objective data are available regarding Ariva's effects in smokers, including its nicotine delivery, cardiovascular profile, or subjective effects. In this single-session, clinical laboratory study, 10 overnight-abstinent cigarette smokers were administered one Ariva tablet, followed 90 min later by two Ariva tablets, followed 90 min later by three Ariva tablets. Participants allowed each dose to dissolve in their mouths according to package instructions. Blood was sampled, heart rate monitored, and subjective effects assessed regularly. Ariva delivered nicotine in a dose-dependent manner; mean (SD) nicotine levels increased from 2.4 ng/ml (0.9) at baseline, to 3.4 ng/ml (1.4) 45 min post-1 tablet, 7.3 ng/ml (4.0) 45 min post-2 tablets, and 9.7 ng/ml (4.4) 45 min post-3 tablets. Heart rate increased after tablet administration, independent of dose. The tablets also significantly decreased subjective ratings of craving and urge, and increased ratings of nausea. Based on this short-term laboratory evaluation, Ariva exposes users to nicotine and may suppress some symptoms of tobacco abstinence, though its nausea-inducing characteristics may limit initial acceptability.

A Prototypical First-Generation Electronic Cigarette Does Not Reduce Reports of Tobacco Urges or Withdrawal Symptoms among Cigarette Smokers

“…Self-reported smoking urges and withdrawal effects were consistent with previous research [7, 8], and reports of “desire or craving to smoke” on the MNWS and six QSU-B items (e.g., “I have a desire for a cigarette right now,” Figure 1) measured during deprivation sessions significantly decreased following smoking CCs but not ECs, suggesting that first-generation ECs may be less effective than CCs in managing self-reported smoking urges. This is consistent with previous studies comparing CCs to ECs delivering aerosol from a single nicotine concentration [2, 3, 12].…”

“…The Questionnaire of Smoking Urges-Brief (QSU-B) [7] was used to assess smoking urges, and the Visual Analog Scale-Smoking Effects (VAS-SE) [8] and Visual Analog Scale-Postsmoking (VAS-PS) assessed smoking or EC use effects. Cognitive tasks included the Digit Symbol Substitution Task (DSST) [9] and the Rapid Information Processing Task (RIP) [10].…”

Evaluating the acute effects of oral, non-combustible potential reduced exposure products marketed to smokers

“…“Mint” was chosen arbitrarily as the flavour for this study. One tablet produces a maximal plasma nicotine concentration of approximately 2.7 ng/ml nicotine 20 21…”

Acute electronic cigarette use: nicotine delivery and subjective effects in regular users

“…an 11 item visual analogue scale was used based on Blank et al, (2008). Participants rate each item by placing a cross through a 200 mm line where the far left indicates 'not at all' and the far right indicates 'extremely'.…”