"I actually finally feel like the cigarettes aren't controlling me." - Interviews with participants smoking very low nicotine content cigarettes during a residential study.
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ABSTRACT: Background
The U.S. Food and Drug Administration (FDA) is considering a low-nicotine product standard for cigarettes. The purpose of this qualitative study was to explore participants' experiences after 72 hours of exclusively smoking very low nicotine content (VLNC) cigarettes.Methods
We conducted a residential study during which participants who smoked cigarettes (N = 16) stayed in a smoking-friendly hotel for 5 days/4 nights. Participants only had access to VLNC cigarettes and were told the cigarettes had 97% less nicotine compared to conventional cigarettes. We conducted individual interviews with participants to assess their initial expectations about VLNC cigarettes, subjective experiences when smoking VLNC cigarettes, opinions regarding a low-nicotine product standard, and predicted use behavior if only VLNC cigarettes were available. Interviews were transcribed verbatim and analyzed using thematic analysis methods.Results
Several participants expected, prior to trying VLNC cigarettes, to compensate for the reduced nicotine levels by smoking more cigarettes but were surprised when they did not increase their smoking. A subset of participants reported experiencing minor withdrawal symptoms, such as irritability and fatigue. Several participants reported feeling less dependent after exclusively smoking VLNC cigarettes. Most participants said they would smoke VLNC cigarettes if they were the only cigarettes available to purchase. Some also said that smoking VLNC cigarettes could help people taper down or quit smoking.Conclusions
Health communication strategies are needed to inform people who smoke about what to expect from a low-nicotine product standard for cigarettes in order to maximize the public health impact of the policy and increase support.
SUBMITTER: Denlinger-Apte RL
PROVIDER: S-EPMC7855643 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The reduction of the nicotine content of cigarettes to nonaddicting levels is a potential federal regulatory intervention to reduce the prevalence of cigarette smoking and related disease. Many clinical trials on the effects and safety of nicotine reduction are ongoing. An important methodologic concern is noncompliance with reduced nicotine content cigarettes in the context of freely available conventional cigarettes. We propose two approaches using biomarkers to estimate noncompliance in smokers of very low nicotine content (VLNC) cigarettes in a clinical trial.Data from 50 subjects in a study of gradual nicotine reduction were analyzed. Using plasma cotinine concentrations measured at baseline and while smoking VLNC cigarettes, we compared within-subject ratios of plasma cotinine comparing usual brand to VLNC in relation to nicotine content of these cigarettes. In another approach, we used nicotine pharmacokinetic data to estimate absolute plasma cotinine/cigarettes per day (CPD) threshold values for compliance based on the nicotine content of VLNC.The two approaches showed concordance, indicating at least 60% noncompliance with smoking VLNC. In a sensitivity analysis assuming extreme compensation and extreme values for nicotine metabolic parameters, noncompliance was still at least 40%, much higher than self-reported noncompliance.Biomarker analysis demonstrates a high degree of noncompliance with smoking VLNC cigarettes, indicating that smokers are supplementing these with conventional cigarettes.We propose a practical approach to assessing compliance with smoking VLNC in clinical trials of nicotine reduction.
| S-EPMC4323626 | biostudies-literature
Project description:There has been long-standing interest in a reduced-nicotine product standard for combusted tobacco, which is within the regulatory purview of the Food and Drug Administration (FDA). In weighing whether to establish this standard, it is important to consider potential responses among people who are at elevated risk for tobacco-related health harms. In this narrative review, we summarize studies of very low nicotine content (VLNC) cigarettes conducted between 2010 and 2021 in groups that the FDA has identified as vulnerable populations. Studies conducted to date in adults with mental health conditions, adults with opioid use disorder, socioeconomically-disadvantaged adults, and youth or young adults indicate that immediate switching to VLNC cigarettes decreases smoking, with minimal or no unintended negative consequences. Few studies have investigated the effects of VLNC cigarettes in racial or ethnic minorities, people who smoke menthol cigarettes, and pregnant women, but initial findings suggest that responses of these individuals are similar to responses observed in other vulnerable populations. We are not aware of studies that have investigated VLNC cigarettes in military/veteran populations, sexual or gender minority individuals, or people living in underserved rural environments. Future research directions include understanding how to promote cessation in the context of a reduced-nicotine standard, and how to correct VLNC misperceptions in vulnerable populations. Nevertheless, the evidence to date indicates that a reduced-nicotine standard is likely to have the same beneficial effects on smoking reductions as it does in less vulnerable populations, which should provide some confidence in pursuing this regulatory approach.
| S-EPMC9699899 | biostudies-literature
Project description:BackgroundReducing the nicotine content in cigarettes could improve public health by reducing smoking and toxicant exposure, but may also have unintended consequences on alcohol use. The primary objective of this study was to examine the effect of reducing the nicotine content in cigarettes on alcohol outcomes. The secondary aim was to examine whether the effects of these cigarettes on alcohol outcomes were mediated by changes in nicotine exposure, smoking behavior, or withdrawal.MethodsBetween June 2013 and July 2014, we conducted a 7-arm, double-blind, randomized clinical trial at 10 U.S.-based sites. Daily smokers not currently interested in quitting (n = 839) were assigned to equally sized groups to smoke for 6 weeks cigarettes containing either normal nicotine content (NNC; 15.8 mg/g, 9 mg tar), moderate nicotine content (5.2 mg/g nicotine, 9 mg tar), or very low nicotine content (VLNC; 0.4 to 2.4 mg/g, 9 to 13 mg tar). This investigation focused on a subsample of current drinkers (n = 403). Each reduced nicotine content cigarette condition was compared to the NNC control condition with respect to trajectories over the 6-week period of average daily alcohol use and occurrence of binge drinking. Moderating variables were considered. Mediation analyses tested potential explanatory processes including changes in nicotine exposure, cigarettes per day, and withdrawal.ResultsOver time, reduced nicotine exposure and smoking rate mediated effects of VLNC cigarette use on reduced alcohol use. There was no evidence of compensatory drinking in response to nicotine reduction or nicotine withdrawal, even among subgroups expected to be at greater risk (e.g., relatively heavier drinkers, highly nicotine-dependent individuals).ConclusionsThe findings suggest that compensatory drinking is unlikely to occur in response to switching to VLNC cigarettes. In contrast, reducing the nicotine content of cigarettes may reduce alcohol use (clinicalTrials.gov number, NCT01681875).
| S-EPMC5347256 | biostudies-literature
Project description:IntroductionMany people incorrectly think that very low nicotine content (VLNC) cigarettes are less carcinogenic than current cigarettes. This risk misperception by people who smoke could reduce motivation to quit under a nicotine reduction policy. We qualitatively examined perspectives on campaign messages designed to reduce misperceptions.Aims and methodsAdults who smoke from North Carolina participated in online interviews. After being introduced to the idea of a VLNC policy, participants were shown VLNC messages and asked about their perceptions on the clarity, understandability, persuasiveness, and meaning of the messages. We conducted a thematic content analysis of the transcripts.ResultsThirty adults who smoke cigarettes participated (15 females, 13 males, 2 nonbinary) with a mean age of 43 years. Central themes that emerged were: (1) Confusion about the proposed VLNC cigarette policy affected how messages were interpreted; (2) Messages that promote self-efficacy for quitting rather than guilt or fear were better received; and (3) Direct and succinct messages were seen as more able to grab attention and inform people who smoke. Some participant concerns focused on whether VLNC cigarettes would relieve their nicotine cravings and whether they would need to smoke more VLNC cigarettes to feel satisfied.ConclusionCampaign messages to educate the public about the harmful effects of smoking VLNC cigarettes may be more effective if people who smoke are informed about the policy's rationale to understand why nicotine is removed rather than the other harmful chemicals. Messages should also acknowledge the difficulty of quitting and be short and direct to capture attention.ImplicationsAdults who smoke have some confusion about nicotine reduction in cigarettes and this affects how they perceive potential communication campaign messages about the risk of smoking VLNC cigarettes. In our qualitative research, we found that adults who smoke prefer messages about VLNC cigarettes that acknowledge the challenge of quitting and that are direct and succinct. With further development, campaign messages may be able to reduce misperceptions about VLNC cigarettes and maximize the public health benefit of a nicotine reduction policy.
| S-EPMC9653078 | biostudies-literature
Project description:SignificanceThe US Food and Drug Administration (FDA) is considering a very low nicotine content (VLNC) product standard to substantially reduce nicotine in cigarettes. We examined whether learning about a potential VLNC standard increased smokers' interest in illicit purchases of cigarettes with regular nicotine content if such a standard were adopted.MethodsParticipants were a national convenience sample of 1712 US adult smokers. In an online experiment, we randomly assigned smokers to view information about a new VLNC standard (experimental condition) or no information (control condition). The experimental condition explained that a VLNC standard would remove 95% of the nicotine in cigarettes and would require stores to only sell VLNC cigarettes. Then, the survey assessed smokers' interest in purchasing regular cigarettes from three illicit sources.ResultsSmokers who learned about the VLNC standard were more likely to be very or extremely interested in purchasing regular cigarettes illicitly from a Web site compared to smokers in the control group (24% vs. 16%, p < .001). They were also more interested in illicitly buying cigarettes from a street vendor (19% vs. 13%, p < .001) and a store on an Indian reservation (28% vs. 22%, p < .05), compared to the control. The impact of learning about the VLNC standard on interest in illicit purchases did not differ by smoking frequency or current e-cigarette use.ConclusionsA VLNC standard could increase smokers' interest in illicit purchases of regular nicotine cigarettes. To prevent VLNC-induced illicit trade from undermining public health, FDA should consider proven measures such as track and trace for these products.ImplicationsLittle is known about how a VLNC cigarette standard would affect consumer interest in regular content cigarettes purchased from illicit sources (eg, the Internet). We found that smokers informed about a potential VLNC product standard had greater interest in illicit cigarette purchases, compared to controls. This suggests the importance of proactive measures accompanying a VLNC standard, such as track-and-trace cigarette packaging regulations and communication campaigns, in order to maximize the standard's public health impact.
| S-EPMC6939751 | biostudies-literature
Project description:IntroductionThe U.S. Food and Drug Administration (FDA) has proposed lowering the nicotine content of cigarettes to a minimally addictive level to increase smoking cessation and reduce initiation. This study has two aims: (1) to determine when cigarette manufacturers had the technical capability to reduce cigarette nicotine content and (2) to estimate the lost public health benefits of implementing a standard in 1965, 1975, or 1985.MethodsTo determine the technical capability of cigarette companies, we reviewed public patents and internal cigarette company business records using the Truth Tobacco Industry Documents. To evaluate the impact of a very low nicotine content cigarette (VLNC) standard on smoking attributable deaths (SADs) and life-years lost (LYLs), we applied a validated (CISNET) model that uses past smoking data, along with estimates of the potential impact of VLNCs derived from expert elicitation.ResultsCigarette manufacturers recognized that cigarettes were deadly and addictive before 1964. Manufacturers have had the technical capability to lower cigarette nicotine content for decades. Our model projected that a standard implemented in 1965 could have averted 21 million SADs (54% reduction) and 272 million LYLs (64% reduction) from 1965 to 2064, a standard implemented in 1975 could have averted 18.9 million SADs and 245.4 million LYLs from 1975 to 2074, and a standard implemented in 1985 could have averted 16.3 million SADs and 211.5 million LYLs from 1985 to 2084.ConclusionsMillions of premature deaths could have been averted if companies had only sold VLNCs decades ago. FDA should act immediately to implement a VLNC standard.ImplicationsPrior research has shown that a mandated reduction in the nicotine content of cigarettes could reduce the prevalence of smoking and improve public health. Here we report that cigarette manufacturers have had the ability to voluntarily implement such a standard for decades. We use a well-validated model to demonstrate that millions of smoking attributable deaths and life-years lost would have been averted if the industry had implemented such a standard.
| S-EPMC7885770 | biostudies-literature
Project description:BackgroundThe US Food and Drug Administration recently issued an advanced notice of proposed rule-making for reducing the nicotine content in cigarettes to a minimally addictive level. Very little is known about whether use of very low nicotine content (VLNC) cigarettes affects support for a nicotine reduction policy.ObjectiveThis study examined the effects of using VLNC versus usual brand (UB) cigarettes on support for a nicotine reduction policy and determined whether participant characteristics and responses to VLNC cigarettes were associated with policy support.MethodsParticipants from a cigarette trial who were assigned to either 0.4 mg nicotine/g tobacco research cigarettes or their UB for 6 weeks were asked about their support for the policy. χ2 tests were used to compare support for the policy between cigarette conditions and logistic regression analyses were conducted to assess covariates associated with policy support.FindingsPolicy support did not differ by condition. After 6 weeks of using VLNC cigarettes, 50% of participants supported the policy, 26% opposed and 24% responded 'Don't Know'. Support was higher among those adherent to smoking only VLNC cigarettes (65%) compared with those who were non-adherent (44%). Older participants and those interested in quitting had increased odds of support. Cigarette satisfaction, perceived harm and perceived nicotine content were not significantly associated with support.ConclusionsSmoking VLNC cigarettes did not affect support for a nicotine reduction policy. Understanding predictors of policy support and opposition will help public health officials to maximise the public health acceptance and impact of this policy (ClinicalTrials.gov Identifier: NCT01681875 Post-Results).
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Project description:IntroductionSmoking to reduce negative affect has been identified as a key motivational feature of tobacco use. Our recent work suggests that smoking very low nicotine content (VLNC) cigarettes reduces the relationship between negative affect and smoking behavior over a 6-week period. Here, we sought to extend our findings by evaluating whether a gradual or immediate approach to switching to VLNC cigarettes led to a differential reduction in the relationship between affect and smoking behavior over a longer (20-week) period.Aims and methodsParticipants (n = 1250) were adult smokers from 10 US sites randomized to one of three groups: gradual nicotine reduction (15.5, 11.7, 5.2, 2.4, and 0.4 mg of nicotine per gram of tobacco [mg/g]), immediate nicotine reduction (0.4 mg/g), or standard nicotine content cigarettes (15.5 mg/g; control), for 20 weeks. We examined whether the relationship between affect-both negative and positive-and cigarettes per day differed as a function of reduction group.ResultsWe found that both negative and positive affect were associated with cigarette consumption in the control group, but not in the gradual or immediate reduction groups across the 20 weeks of exposure.ConclusionsOur results extend previous findings that switching to VLNC cigarettes disrupts the relationship between affect and cigarette consumption by showing that either gradually or immediately reducing cigarette nicotine content achieves this disruption. These findings provide further evidence that switching to VLNC cigarettes reduces nicotine-related reinforcement of cigarette smoking.ImplicationsThese findings support the notion that switching to very low nicotine content cigarettes reduces the association between affect and smoking behavior, and that either a gradual or immediate nicotine reduction approach achieves this reduction. This provides further evidence that switching to very low nicotine content cigarettes weakens reinforcement mechanisms associated with nicotine dependence.
| S-EPMC7364840 | biostudies-literature
Project description:The present systematic review examines whether very low nicotine content (VLNC) cigarettes ameliorate withdrawal-induced impairments in behavioral/cognitive performance. PubMed, PsycInfo, and Web of Science were searched for performance effects of VLNC cigarettes. For inclusion, reports had to be in English, published in a peer-reviewed journal through June 2017, examine VLNC cigarettes (<0.2mg nicotine yield), include ≥2hour smoking abstinence or reduced nicotine exposure, and examine performance. 19 of 1243 articles reviewed met inclusion criteria. Poorer performance after smoking VLNC versus normal nicotine content (NNC) cigarettes was observed across 7 of 10 domains, including reaction time (8/11), short-term memory (3/10), sustained attention (4/6), inhibitory control (1/4), long-term memory (3/3 studies), and response variability (2/2). In two studies, combining VLNC smoking with nicotine replacement therapy (NRT) resulted in performance that was comparable to performance after NNC smoking. VLNC versus NNC differences were not discerned in motor control/functioning (0/2), visuospatial processing (0/2), learning (0/1), or verbal fluency (0/1). Eleven of nineteen (58%) studies were rated of Good or Excellent quality. Overall, VLNC cigarettes may not fully ameliorate withdrawal-induced disruptions in performance, although this varies by domain, with the strongest evidence for reaction time. Importantly, combining VLNC cigarettes with NRT appears to ameliorate withdrawal that is not reduced by VLNC cigarettes alone. As only 19 studies were identified, many domains are under-investigated. A more thorough evaluation of the extent to which VLNC cigarettes affect withdrawal-impaired performance may be warranted.
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