Tobacco Harm Reduction with Vaporised Nicotine (THRiVe): The Study Protocol of an Uncontrolled Feasibility Study of Novel Nicotine Replacement Products among People Living with HIV Who Smoke.
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ABSTRACT:
SUBMITTER: Bell S
PROVIDER: S-EPMC5551237 | biostudies-other | 2017 Jul
REPOSITORIES: biostudies-other
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Project description:People living with HIV (PLHIV) have high rates of tobacco smoking. Nicotine vaping products (NVPs) may promote tobacco smoking cessation and/or harm reduction. This study aimed to trial the feasibility of NVPs for promoting tobacco smoking cessation among PLHIV. The Tobacco Harm Reduction with Vaporised Nicotine (THRiVe) study was a mixed-methods trial among 29 PLHIV who used tobacco daily. Participants trialled a 12-week intervention of NVPs. This study reports descriptive analyses of quantitative data on tobacco abstinence and associated adverse events. Short-term abstinence (7-day point prevalence; i.e., no tobacco use for 7 days) was achieved by 35% of participants at Week 12 and 31% reported short-term abstinence at Week 24. Sustained medium-term abstinence (8 weeks' abstinence) was achieved by 15% of participants at Week 12 and 31% at Week 24. Most adverse events were mild. NVPs may represent a feasible and potentially effective short-to-medium term tobacco smoking cessation aid and/or harm reduction strategy among PLHIV.
| S-EPMC9908735 | biostudies-literature
Project description:ObjectivesAlthough tobacco is the leading preventable cause of death in the USA, it is routinely sold in pharmacies. In 2008, San Francisco became the first city in the USA to pass a tobacco-free pharmacy ordinance. Over the next decade, 171 municipalities enacted similar policies, and in 2018, Massachusetts banned tobacco sales in pharmacies. Our objective was to assess the perceived effects of tobacco-free pharmacy policies on displays, sales, customer visits and counselling.DesignObservational study and survey.SettingIn 2017, we visited Walgreens and CVS stores in San Francisco and nearby San Jose, which allows tobacco sales, to assess placement of tobacco and over-the-counter tobacco cessation products (nicotine replacement therapy or NRT). We surveyed an employee at each site regarding the impact that tobacco-free pharmacy policies had had on customer traffic and sales of NRT.ParticipantsWe obtained display data from 72 pharmacies and collected surveys from 55 employees (76% response rate).ResultsA majority of respondents at tobacco-free pharmacies (55%) reported that the policy had not affected customer visits. In comparison, 70% of respondents at tobacco-selling pharmacies believed that eliminating tobacco sales would reduce the number of customers visiting their stores. Pharmacies that were tobacco free and those that sold tobacco reported comparable displays, sales and counselling for NRT.ConclusionsPharmacies operating under tobacco-free policies did not report reduced customer visits. Greater awareness of this outcome could help pharmacies implement public health recommendations to eliminate tobacco sales.
| S-EPMC6588971 | biostudies-literature
Project description:Nicotine pouches to be put under the upper lip are a new category of products that are being rapidly developed and marketed as consumer goods with little research or regulatory oversight. We have identified research gaps in assessing their harm and benefit potential, and possible regulatory science approaches to inform the policies that can allow a maximization of the category's public health potential while minimizing unintended consequences. Implications: This commentary presents a potential blueprint for a comprehensive assessment of the nicotine pouches category. Data from the proposed research areas can better inform the regulatory policy decisions around the category, with the aim to maximize the category's tobacco harm reduction potential while minimizing unintended harms.
| S-EPMC8887571 | biostudies-literature
Project description:Most people start experimenting with tobacco products or e-cigarettes in early adolescence and become habitual smokers in late adolescence or adulthood. These studies investigated if exposure to tobacco smoke or nicotine during early and mid-adolescence affects nicotine intake in late adolescence and early adulthood. Male and female rats were exposed to tobacco smoke from low- and high-nicotine SPECTRUM cigarettes or nicotine (0.3 mg/kg, twice a day) from postnatal day (P) 24-42. The self-administration sessions started at P55. The rats self-administered nicotine for 14-15 days under a fixed-ratio 1 schedule, and on the first day, the maximum number of infusions was twenty. Exposure to smoke from high, but not low, nicotine cigarettes during adolescence increased nicotine self-administration in female but not male rats. Adolescent treatment with nicotine facilitated nicotine self-administration. On the first day of nicotine self-administration, nicotine-treated rats reached the maximum number of infusions before the saline-treated control rats. Nicotine intake was also higher in the nicotine-treated female rats than in the saline-treated females. There was no sex difference in nicotine intake in controls when the data from the studies were combined. Smoke exposure led to a dose-dependent increase in plasma nicotine and cotinine levels in adolescent rats. Exposure to smoke from high-nicotine cigarettes and 0.3 mg/kg of nicotine led to plasma nicotine and cotinine levels that are similar to those in tobacco users. These findings indicate that in females, but not males, exposure to nicotine during adolescence may facilitate smoking and e-cigarette use later in life.
| S-EPMC7660018 | biostudies-literature
Project description:Second Hand Smoke (SHS) has always been primarily linked with indoor pollution. To date nicotine was the favoured marker for SHS alongside measurements of particulate matter (PM) levels. As nicotine is mainly found in the gas-phase and reactive in the outdoor environment it is not ideal as a marker for the SHS-driven particulate component in PM. Nicotelline, a minor tobacco alkaloid that is stable, found almost exclusively in the particle phase and easy to quantify even at low concentrations, is being proposed as a better marker. It is the first study using bisulfate-treated quartz fiber filters to show that airborne nicotine (gas+particle phase) is directly proportional to airborne nicotelline in countries that have different climates. The analytical method developed has been validated to show that the use of untreated filters is suitable for the quantification of nicotelline even at low concentrations. Although nicotelline exhibits a seasonal and geographical variation, this is the first comprehensive study which demonstrates the ubiquitous presence of nicotelline in PM from outdoor air samples collected in the USA (0.1-285.6 pgm-3), UK (2.3-9.1 pgm-3), Hong Kong (3.8-109.3 pgm-3) and Malta (4.2-280.8 pgm-3). From the nicotelline apportionment factor of 1589 ng/mg of tobacco smoke PM we estimate the fraction of outdoor airborne PM derived from SHS to be in the range of 0.03-0.08%. While it is unlikely for tobacco smoke-related toxics in outdoor PM to be considered a major health hazard, in heavily polluted microenvironments this marker would be useful in tracing the presence of SHS and emerging Third Hand Smoke components that form or are found in airborne and settled PM that could induce serious health effects.
| S-EPMC7987222 | biostudies-literature
Project description:While much is known about the demand for cigarettes, research on the demand for non-cigarette tobacco products and the cross-price impacts among those products is limited. This study aims to comprehensively examine the own- and cross-price elasticities of demand for tobacco and nicotine replacement products (NRPs) in the U.S. We analyzed market-level quarterly data on sales and prices of 15 different types of tobacco products and NRPs from 2007 to 2014, compiled from retail store scanner data. Fixed effects models with controls were used to estimate their own-price elasticities and cross-price elasticities between cigarettes and the other 14 products. Our results show that, except for cigars, the demand for combustible tobacco products was generally elastic, with the estimated own-price elasticity >1 (10% increase in prices reduces sales by >10%). The own-price elasticities for smokeless tobacco products were smaller than those for combustible tobacco, although not always significant. The demand for electronic cigarettes and NRPs was found to be elastic. The cross-price elasticities with respect to cigarettes were positive for cigarillos, little cigars, loose tobacco, pipe tobacco, electronic cigarettes and NRPs, but only results for little cigars, loose tobacco, pipe tobacco, and dissolvable lozenges were consistently significant. Our findings suggest demand for tobacco products and NRPs was responsive to changes in their own prices. Substitutions or positive cross-price impacts between cigarettes and certain other products exist. It is important that tobacco control policies take into account both own- and cross-price impacts among tobacco products and NRTs.
| S-EPMC6195827 | biostudies-literature
Project description:BackgroundIntroduction of new tobacco products in the United States, including those that may be lower on the risk continuum than traditional combustible cigarettes, requires premarket authorization by the US Food and Drug Administration and information on the potential impact of the products on consumer behaviors. Efficient recruitment and data capture processes are needed to collect relevant information in a near-to-real-world environment.ObjectiveThe aim of this pilot study was to develop and test a protocol for an actual use study of a new tobacco product. The product included in this study was a commercially available oral nicotine pouch. Through the process of study design and execution, learnings were garnered to inform the design, execution, analysis, and report writing of future full-scale actual use studies with tobacco products.MethodsA small sample (n=100) of healthy adult daily smokers of 7 or more cigarettes per day were recruited to participate in an 8-week prospective observational study conducted at 4 geographically dispersed sites in the United States. A smartphone-based customized electronic diary (eDiary) was employed to capture daily tobacco product use, including 1 week of baseline smoking and 6 weeks during which participants were provided with oral nicotine pouches for use as desired.ResultsOnline screening procedures with follow-up telephone interviews and on-site enrollment were successfully implemented. Of 100 participants, 97 completed the study, with more than half (59/99, 60%) identifying as dual- or poly-users of cigarettes and other types of tobacco products at baseline. There was more than 90% (91-93/99, 92%-94%) compliance with daily eDiary reporting, and the majority (92/99, 93%) of participants expressed satisfaction with the study processes. Product use data from the eDiary indicated that after an initial period of trial use, pouches per day increased among those continuing to use the products, while per day average cigarette consumption decreased for 82% (79/97) of all study participants. At the end of the week 6, 16% (15/97) of participants had reduced their cigarette consumption by more than half.ConclusionsThe design of this study, including recruiting, enrollment, eDiary use, and oversight, was successfully implemented through the application of a detailed protocol, a user-friendly eDiary, electronically administered questionnaires, and remote monitoring procedures. High-resolution information was obtained on prospective changes in tobacco product use patterns in the context of availability of a new tobacco product. Future, larger actual use studies will provide important evidence supporting the role that alternatives to combustible cigarettes may play in smoking reduction and/or cessation and lowering the population health burden of tobacco and nicotine-containing products.
| S-EPMC9440415 | biostudies-literature
Project description:Many countries, including the UK, recommend nicotine replacement therapy (NRT) for smoking cessation during pregnancy. However, adherence to NRT is generally low, smoking lapse or relapse is common and using NRT to reduce the harm from the number of cigarettes smoked is only advocated in non-pregnant smokers. Two focus groups were conducted with 13 professionals involved in antenatal stop smoking services (SSS). The data were analysed thematically. Two themes were extracted that describe health professionals' attitudes towards using NRT either during lapses or to reduce smoking in women who cannot quit (harm reduction). These are presented around a social-ecological framework describing three hierarchical levels of influence within smoking cessation support: (1) Organizational: providing NRT during lapses could be expensive for SSS though harm reduction could result in services helping a wider range of clients. (2) Interpersonal: participants felt using NRT for harm reduction was not compatible with cessation-orientated messages practitioners conveyed to clients. (3) Individual: practitioners' advice regarding using NRT during smoking lapses varied; many were generally uncomfortable about concurrent smoking and NRT use and had strong reservations about recommending NRT when smoking during all but the briefest lapses. Further evidence is required to guide policy and practice.
| S-EPMC6926779 | biostudies-literature
Project description:In the USA, new regulations require the collection of information on tobacco constituents by brand and variety and publication of this information in a way not likely to be misconstrued by consumers. Understanding of such information becomes increasingly important as new tobacco products are marketed and modifications are made to reduce the toxicity of some products. This pilot study assessed the current knowledge of tobacco control professionals regarding the relative harmfulness of several tobacco products, and evaluated an online educational intervention aimed at improving understanding of variations in nicotine and tobacco-specific N-nitrosamines (TSNAs).Fifty-two tobacco control professionals participated in an online intervention which presented and discussed the results of constituent analyses of Camel Snus and Marlboro Snus compared to several conventional smokeless tobacco products. Comparisons with cigarettes were also discussed. Pre- and post-intervention questions assessed understanding of the concepts.Pre-intervention responses demonstrated that 31% did not know that cigarettes are more harmful than smokeless tobacco, 67% did not know that smokeless products higher in nicotine are likely to be more effective substitutes for cigarettes, 52% did not know TSNAs are the major carcinogens in tobacco and 81% did not know new snus products tend to be lower in TSNAs than conventional spit tobacco. After intervention participation, knowledge increased on all points except one where pretest results were 100% correct.Public education campaigns are urgently needed for tobacco control professionals and consumers to increase awareness and understanding of the continuum of risk among tobacco products.
| S-EPMC4119095 | biostudies-literature
Project description:IntroductionMost pregnant women with substance use problems smoke, and few will quit during their pregnancy. Tobacco treatment is often overlooked, with the focus usually placed on other substance use. Additionally, few targeted effective treatments for this group exist. To address this, the feasibility of an intensive tobacco treatment incorporating contingency management (CM) that featured non-face-to-face delivery was examined.MethodsA single-arm pre-post design feasibility trial was conducted in three antenatal services that support women who use substances in metropolitan Australia. Participants were over the age of 15, had <33-week gestation, and smoked tobacco daily. They received financial incentives for daily carbon monoxide-verified smoking abstinence or reduction through an internet-based CM programme, nicotine replacement therapy (NRT) posted to women and partners or household members who smoked and telephone-delivered behavioral counseling from study enrolment to birth.ResultsOf the 101 referrals, 46 women (46%) consented. The mean (SD) age was 31(±6) years, and the gestation period was 22(±6) weeks. Nineteen (41%) of those enrolled were retained for 12-week postpartum. Of 46 women, 32 (70%) utilized CM; 32 (70%) used NRT for ≥2 weeks; 23 (50%) attended ≥1 counseling session; and 15 (22%) received NRT for partners/household members. Fifteen (33%) were verified abstinent from tobacco at delivery after a median (IQR) period of abstinence of 65(36-128) days. All non-smokers at birth utilized NRT and financial incentives, and 9/15 (60%) utilized counseling. Four (9%) were abstinent at 12-week postpartum. Median cigarettes smoked/day reduced from baseline to delivery (10(6-20) to 1(0-6) p =< 0.001). Women who quit smoking had more education (72% vs. 33% p =< 0.02), completed more CO samples (median (IQR) 101(59-157) vs. 2(0-20) p =< 0.001), and received more incentives (median (IQR) $909($225-$1980) vs. $34($3-$64) p =< 0.001). Intervention acceptability was rated favorably by participants (9 items rated 0-10 with scores >5 considered favorable).DiscussionThis study demonstrated the feasibility and acceptability of a consumer-informed, non-face-to-face intensive tobacco treatment, highlighting the potential of remotely delivered technology-based CM to reduce the health impact of tobacco smoking in high-priority populations. The intervention demonstrates scale-up potential. Future studies should extend treatment into the postpartum period, utilizing new technologies to enhance CM delivery and improve counseling provision and partner support.Clinical trial registrationhttps://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374196, ACTRN1261800056224.
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