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1.
Contemp Clin Trials ; : 107662, 2024 Aug 12.
Article in English | MEDLINE | ID: mdl-39142511

ABSTRACT

BACKGROUND: Mitigating attrition is a key component to reduce selection bias in longitudinal randomized controlled trials (RCTs). Few studies of electronic nicotine delivery systems (ENDS) allow for the examination of long-term retention. This analysis explores the relationship between attrition, baseline measures, and condition assigned for a RCT involving ENDS differing in nicotine delivery over a 24-week intervention period. METHODS: Participants (N = 520) who smoked ≥10 cigarettes per day [CPD] for ≥1 year and reported interest in reducing but not quitting were randomized to 1 of 4 conditions: an ENDS containing 0, 8, or 36 mg/ml liquid nicotine (administered double-blind) or a cigarette-shaped plastic tube. Cox proportional hazards regression models were fit to examine attrition over time and predictors of attrition including baseline characteristics and condition. A stepwise approach was used to determine the final model; alpha was set at 0.05. RESULTS: Attrition did not differ significantly by condition (223/520), and most (69%) were lost-to-follow-up. Only age, education level, and household income were significantly predictive of attrition. For every additional year of age, attrition risk fell by 3%. Holding a bachelor's degree or higher was associated with reduced attrition risk. Those with the lowest income (<$10 K) were more likely to be withdrawn compared to those earning $10 K-39 K, and those with the highest income ($100 K+) were more likely to be withdrawn compared with the latter bracket and those earning $70-99 K. CONCLUSION: ENDS nicotine content did not drive differential attrition in this trial, and targeted retention efforts is needed for specific subgroups. Trial Registration #: NCT02342795.

2.
Chem Res Toxicol ; 37(7): 1121-1128, 2024 Jul 15.
Article in English | MEDLINE | ID: mdl-38953874

ABSTRACT

Implementation of the Tobacco Control Act in 2009 banned characterizing flavors in cigarettes (except menthol and tobacco), but substitution has occurred by the continued availability of alternative flavored products (i.e., flavored little cigars). Little is known about how flavorants in noncigarette tobacco products impact human health. Thus, we investigated the impact of flavorants on free radical production in the mainstream smoke of little cigars. Gas- and particulate-phase free radical yields in mainstream smoke generated from 12 commercial little cigar brands and research little cigars and cigarettes were measured via electron paramagnetic resonance spectroscopy using the International Organization of Standardization (ISO) smoking protocol. Flavorants were extracted from unsmoked little cigars and analyzed by gas chromatography-mass spectroscopy. Gas- and particulate-phase radical yields from little cigars ranged from 13.5 to 97.6 and 0.453-1.175 nmol/unit, respectively. Comparatively, research cigarettes yielded an average of 4.9 nmol gas-phase radicals/unit and 0.292 nmol particulate-phase radicals/unit. From the products, 66 flavorants were identified, with each brand containing 4-24 individual flavorants. The free radical content was strongly correlated with the number of flavorants present in each cigar (r = 0.74, p = 0.01), indicating that highly flavored little cigars may produce higher levels of toxic free radicals. The presence of the flavorant ethyl methylphenylglycidate (strawberry) was associated with >2-fold higher levels of GP radicals (p = 0.001). Our results show that free radical delivery from little cigars is greater than that from research cigarettes and provide empirical evidence for the harmfulness of flavored tobacco products. Additionally, it demonstrates that flavorants present in combustible tobacco products can influence the levels of free radicals produced. Therefore, future tobacco product standards should consider little cigars.


Subject(s)
Flavoring Agents , Smoke , Tobacco Products , Flavoring Agents/analysis , Flavoring Agents/chemistry , Free Radicals/analysis , Free Radicals/chemistry , Tobacco Products/analysis , Smoke/analysis
3.
Tob Control ; 2024 Mar 18.
Article in English | MEDLINE | ID: mdl-38471776

ABSTRACT

BACKGROUND: Research is needed to understand the acceptability of electronic nicotine delivery systems (ENDS) as a smoking reduction aid. This study examines the acceptability of ENDS by liquid nicotine concentration and flavour among people who smoke using ENDS to reduce their smoking. METHODS: People who smoke cigarettes but were naïve to ENDS participated in a double-blind randomised controlled trial to reduce conventional cigarette smoking. Participants were randomised to either a control cigarette substitute (CS) or one of three ENDS groups; 0 mg/mL, 8 mg/mL or 36 mg/mL nicotine concentration. ENDS flavour was chosen by the participant (tobacco or menthol). Participants reported their CS, ENDS and cigarettes per day (CPD) from the past 7 days at 1-month, 3-month and 6-month follow-up visits. Participants also reported side effects and measures of satisfaction, psychological reward, aversion and craving relief. Outcome variables were modelled using linear mixed effects by the following groups: liquid nicotine concentration, flavour and a flavour-nicotine concentration interaction. RESULTS: Participants (n=520) were 41.2% male, 67.3% white, had a mean age of 46.2 years and smoked a mean of 18.6 CPD (SD=7.74) at baseline. All flavour and concentration groups decreased CPD from baseline to all follow-up visits with the 36 mg/mL experiencing the greatest reduction, compared with the 0 mg/mL and 8 mg/mL groups. All groups except the 36 mg/mL group decreased their product use over time. The use of menthol flavour was associated with fewer side effects at 3 months (p=0.02) and lesser aversion at 1 month (p=0.03) compared with tobacco-flavoured ENDS. The 36 mg/mL group experienced the greatest craving relief and greatest aversion compared with other groups. CONCLUSIONS: Both nicotine concentration and flavour appear to have independent, as well as interactive, effects that influence ENDS acceptability among people who use cigarettes.

4.
Am J Infect Control ; 52(5): 509-516, 2024 May.
Article in English | MEDLINE | ID: mdl-38218328

ABSTRACT

BACKGROUND: The COVID-19 vaccine was initially offered to frontline health care workers (HCWs), due to the high risk of contracting COVID-19 through occupational exposure to patients. Low HCW vaccine uptake can impact overall community-level vaccine uptake. This study used the Diffusion of Innovation (DOI) Theory to understand factors related to COVID-19 vaccine uptake in HCWs. METHODS: We surveyed Pennsylvanian HCWs (excluding Philadelphia) from August 2022 to February 2023. Survey questions inquired about demographics, COVID-19 vaccination status, reasons for receiving/declining the COVID-19 vaccine, and sources of information about the vaccine. RESULTS: Participants (n = 3,490) were 85% female, 89% White, and 93% (n = 3,255) reported receiving at least one dose of a COVID-19 vaccine. HCWs were categorized into adopter categories of the DOI Theory: innovators (56%), early adopters (9%), early majority (11%), late majority (7%), and laggards (17%). The major reason that prompted participants to get the vaccine was to protect them against COVID-19 infection (78%), while the major reason for declining the vaccine was due to concern about possible side effects from the vaccine (78%). CONCLUSIONS: We applied the DOI Theory to characterize adopters and identify factors related to COVID-19 vaccine uptake in HCWs. As updated COVID-19 vaccines are approved for the United States market, our findings may be used to improve vaccine education and communication among HCWs to support vaccine uptake.

5.
Nicotine Tob Res ; 26(3): 397-401, 2024 Feb 22.
Article in English | MEDLINE | ID: mdl-37434562

ABSTRACT

INTRODUCTION: IQOS was authorized by the U.S. Food and Drug Administration (FDA) as a modified-risk tobacco product. We conducted a pharmacokinetic study evaluating the nicotine delivery and subjective effects of IQOS use among current menthol cigarette smokers to better understand if IQOS is an acceptable cigarette alternative in light of the proposed menthol cigarette ban. AIMS AND METHODS: Participants were adult smokers of >4 menthol cigarettes per day. After 14-hour nicotine abstinence, participants were provided an IQOS device and menthol heatstick to puff every 20 seconds for a total of 14 puffs. Blood samples were collected at baseline and during active use to calculate nicotine boost from baseline to peak concentration. Nicotine withdrawal symptoms were collected before and after IQOS use. In addition, a modified Product Evaluation Scale for IQOS was collected after use. RESULTS: Participants (n = 8) were a mean age of 43.9 years, 63% were female, 88% identified as White, and they smoked a mean of 17.1 menthol cigarettes per day. After IQOS use, the mean nicotine boost obtained was 15.96 ng/mL (SD = 6.91) (range 9.31 to 30.55 ng/mL). Most (75%) participants reported enjoying use of the product "a lot" or greater and more than half (62.5%) reported reduced cigarette cravings. Most participants reported no side effects after use; however, two experienced dry mouth, three experienced dizziness, one experienced throat irritation, and one experienced headache. CONCLUSION: We found that directed use (14 puffs) of menthol IQOS delivered a mean nicotine boost of 15.96 ng/mL which reduced craving for a cigarette. The majority of participants enjoyed use of IQOS and reported mild side effects. IMPLICATIONS: Menthol IQOS delivered a sufficient dose of nicotine perceived as satisfying by menthol cigarette smokers and it reduced craving with mild side effects. Menthol IQOS has potential to serve as a less harmful alternative for menthol cigarette smokers. The availability of modified risk products like IQOS should be considered by FDA's Comprehensive Plan for Tobacco and Nicotine Regulation.


Subject(s)
Electronic Nicotine Delivery Systems , Tobacco Products , Adult , Female , Humans , Male , Nicotine , Menthol/adverse effects , Hot Temperature , Tobacco Products/adverse effects
6.
Subst Use Misuse ; 59(4): 601-607, 2024.
Article in English | MEDLINE | ID: mdl-38115560

ABSTRACT

OBJECTIVES: Dual use of combustible cannabis and nicotine is related to worse mental health symptoms (MHS); however, little is known about MHS among those who vape cannabis and nicotine. The current study aimed to determine if dual use of cannabis and nicotine vapes is associated with worse MHS compared to single use and to identify correlates of MHS for dual users. METHODS: We used Amazon Mechanical Turk to survey adults (N = 492) who used nicotine or cannabis vapes in the past 30 days on stress, anxiety, depression, vape use behaviors and sociodemographic information. We conducted hierarchical linear regressions to compare MHS between dual vs. single substance vape use and to identify correlates of MHS, including sociodemographic variables and vape use characteristics. RESULTS: The final sample was 37.6% female, 87.6% White, and 11% Hispanic/Latinx with a mean age of 34.15 years. After controlling for sociodemographic characteristics and combustible product use, dual users had significantly higher mean MHS severity than single users. For dual users, younger age and being married were associated with higher symptoms of depression and stress. Holding a medical cannabis card was associated with higher anxiety symptoms. CONCLUSION: The findings suggest that dual use of cannabis and nicotine vapes is associated with worse MHS severity compared to single substance use.


Subject(s)
Cannabis , Electronic Nicotine Delivery Systems , Hallucinogens , Vaping , Adult , Humans , Female , Male , Nicotine/adverse effects , Vaping/psychology , Mental Health
8.
Psychooncology ; 32(8): 1147-1162, 2023 08.
Article in English | MEDLINE | ID: mdl-37226331

ABSTRACT

OBJECTIVES: Continued smoking after cancer diagnosis is associated with worse outcomes, however, many persons diagnosed with cancer who smoke are unable to quit successfully. Effective interventions are needed to promote quitting in this population. The purpose of this systematic review is to understand the most effective interventions for smoking cessation among persons with cancer and to identify gaps in knowledge and methodology to suggest directions for future research. METHODS: Three electronic databases (The Cochrane Central Register of Controlled trials, MEDLINE, and EMBASE) were searched for studies of smoking cessation interventions among persons with cancer, published up to 1 July 2021. Title and abstract screening, full-text review, and data extraction was completed by two independent reviewers, via Covalence software, with any discordance resolved by a third reviewer. A quality assessment was completed using the Cochrane Risk of Bias Tool Version 2. RESULTS: Thirty-six articles were included in the review, including 17 randomized-controlled trials (RCTs) and 19 non-RCT studies. Of the 36 studies, 28 (77.8%) utilized an intervention that included both counseling and medication, with 24 (85.7%) providing medication to participants at no cost. Abstinence rates in the RCT intervention groups (n = 17) ranged from 5.2% to 75%, while the non-RCTs found abstinence rates ranging from 15% to 46%. Overall, studies met a mean of 2.28 out of seven quality items, ranging from 0 to 6. CONCLUSIONS: Our study highlights the importance of utilizing intensive combined behavioral and pharmacological interventions for persons with cancer. While combined therapy interventions seem to be the most effective, more research is needed, as current studies have several quality issues, including the lack of biochemical verification for abstinence.


Subject(s)
Neoplasms , Smoking Cessation , Humans , Smoking Cessation/psychology , Behavior Therapy , Counseling
9.
Drug Alcohol Depend ; 243: 109708, 2023 02 01.
Article in English | MEDLINE | ID: mdl-36608485

ABSTRACT

BACKGROUND: Most adults who regularly use e-cigarettes or Electronic Nicotine Delivery Systems (ENDS) desire to discontinue use. ENDS use can result symptoms of nicotine withdrawal and dependence which can make it more difficult to discontinue use. Brief, valid assessment of nicotine dependence among adults who use ENDS is needed to guide treatment for nicotine dependence in this group. We sought to develop a brief, valid instrument to measure nicotine dependence among adults seeking to discontinue ENDS in a busy Quitline. METHODS: In this cross-sectional design, we examined content, construct, and concurrent validity of the Roswell ENDS Nicotine Dependence Scale (Roswell eND Scale) and the Penn State E-Cigarette Dependence Index (Penn State eCDI). Participants who called the New York Quitline from November 2019 to June 2020 seeking to discontinue ENDS use were invited to participate. Construct validity was examined with exploratory and confirmatory factor analyses. Instrument and factor scores were then correlated with cotinine, a biomarker of nicotine exposure. RESULTS: All participants (n = 209) were highly dependent and co-used combustible cigarettes to varying degrees. Both instruments demonstrated content validity and construct validity, however only the 5-item Roswell eND Scale demonstrated criterion-related validity by showing a significant positive correlation with salivary cotinine levels. CONCLUSIONS: The 5-item Roswell eND Scale can briefly and effectively assess nicotine dependence among treatment-seeking adults who co-use ENDS and cigarettes. These preliminary psychometric findings have the potential to be generalizable to other adults seeking to discontinue ENDS use, many of whom currently or formerly smoked cigarettes.


Subject(s)
Electronic Nicotine Delivery Systems , Tobacco Products , Tobacco Use Disorder , Vaping , Humans , Adult , Tobacco Use Disorder/diagnosis , Nicotine , Cotinine , Cross-Sectional Studies
11.
Nicotine Tob Res ; 25(3): 372-378, 2023 02 09.
Article in English | MEDLINE | ID: mdl-35752091

ABSTRACT

INTRODUCTION: How nicotine dependence will be affected when current smokers initiate electronic cigarette (e-cigarette) use to reduce cigarette smoking is unknown. This study evaluated cigarette, e-cigarette, and total nicotine dependence more than 6 months among smokers reducing cigarette consumption by replacing with e-cigarettes. AIMS AND METHODS: Adult cigarette smokers were randomized to one of four conditions (36 mg/ml e-cigarette, 8 mg/ml e-cigarette, 0 mg/ml e-cigarette, or cigarette-substitute [CS] [provided at no cost]) and instructed to reduce their cigarette smoking by 75% at 1 month. Participants completed follow-up at 1, 3, and 6 months. The Penn State Nicotine Dependence Index (PSNDI) measured dependence on cigarettes (PSCDI) and e-cigarettes (PSECDI). Urine cotinine measured total nicotine exposure. Linear mixed effects models for each outcome were conducted and included interaction terms between visit and condition. RESULTS: Participants (n = 520) were 58.8% female, 67.3% White, and 48.0 years old. At baseline, the median number of cigarettes smoked per day was 17.3 and the mean PSCDI score was 13.4, with no significant differences between conditions. Participants in the e-cigarette conditions reported significantly lower PSCDI scores, compared with baseline, and with the CS condition at all follow-up visits. Those in the 36 mg/ml e-cigarette condition reported greater PSECDI scores at 6 months, compared with baseline and the 0 mg/ml and 8 mg/ml conditions. At all follow-up visits, there were no differences in total nicotine exposure compared to baseline, nor between any conditions. CONCLUSIONS: E-cigarette use was associated with reduced cigarette dependence, compared to the CS, without significant increases in total nicotine exposure. IMPLICATIONS: Initiation of electronic cigarette use while continuing to smoke could potentially increase nicotine dependence. In this randomized trial aimed at helping smokers to reduce their cigarette intake, we found that use of an e-cigarette was associated with a reduction in cigarette dependence and an increase in e-cigarette dependence (in the condition with the highest nicotine concentration only), with no long term increase in total nicotine dependence or nicotine exposure.


Subject(s)
Cigarette Smoking , Electronic Nicotine Delivery Systems , Smoking Cessation , Tobacco Products , Tobacco Use Disorder , Adult , Humans , Female , Male , Tobacco Use Disorder/prevention & control , Nicotine , Smokers , Nicotiana
12.
PLoS One ; 17(11): e0275522, 2022.
Article in English | MEDLINE | ID: mdl-36322562

ABSTRACT

BACKGROUND: The U.S. Food and Drug Administration and the government of New Zealand have proposed a reduction of the nicotine content in cigarettes to very low levels. This study examined the potential effects of this regulation in smokers with affective disorders. METHODS: In a randomized controlled parallel group trial conducted at two sites in the USA (Penn State University, Hershey, PA and Massachusetts General Hospital, Boston, MA) 188 adult smokers with a current (n = 118) or lifetime (n = 70) anxiety or unipolar mood disorder, not planning to quit in the next 6 months, were randomly assigned (1:1) to smoke either Usual Nicotine Content (UNC) (11.6 mg nicotine/cigarette) research cigarettes, or Reduced Nicotine Content (RNC) research cigarettes where the nicotine content per cigarette was progressively reduced to 0.2 mg in five steps over 18 weeks. Participants were then offered the choice to either receive assistance to quit smoking, receive free research cigarettes, or resume using their own cigarette brand during a 12-week follow-up period. Main outcomes were biomarkers of nicotine and toxicant exposure, smoking behavior and dependence and severity of psychiatric symptoms. The pre-registered primary outcome was plasma cotinine. RESULTS: A total of 143 (76.1%) randomized participants completed the randomized phase of the trial, 69 (73.4%) in the RNC group and 74 (78.8%) in the UNC group. After switching to the lowest nicotine content cigarettes, compared to smokers in the UNC group, at the last randomized visit the RNC group had significantly lower plasma cotinine (metabolite of nicotine): difference between groups, -175.7, 95% CI [-218.3, -133.1] ng/ml. Urine NNAL (metabolite of NNK, a lung carcinogen), exhaled carbon-monoxide, cigarette consumption, and cigarette dependence were also significantly lower in the RNC group than the UNC group. No between-group differences were found on a range of other biomarkers (e.g. 8-isoprostanes) or health indicators (e.g. blood pressure), or on 5 different psychiatric questionnaires, including the Kessler K6 measure of psychological distress. At the end of the subsequent 12-week treatment choice phase, those randomized to the RNC group were more likely to have quit smoking, based on initial intent-to-treat sample, n = 188 (18.1% RNC v 4.3% UNC, p = 0.004). CONCLUSION: Reducing nicotine content in cigarettes to very low levels reduces some toxicant exposures and cigarette addiction and increases smoking cessation in smokers with mood and/or anxiety disorders, without worsening mental health. TRIAL REGISTRATION: TRN: NCT01928758, registered August 21, 2013.


Subject(s)
Nicotine , Tobacco Products , Adult , Humans , Nicotine/adverse effects , Smokers/psychology , Cotinine , Tobacco Products/adverse effects , Anxiety Disorders , Biomarkers , Hazardous Substances , Smoking/adverse effects
13.
Brain Res Bull ; 189: 131-138, 2022 10 15.
Article in English | MEDLINE | ID: mdl-36038015

ABSTRACT

BACKGROUND: Menthol upregulates nicotinic acetylcholine receptors and is associated with tobacco dependence. The effects of menthol when smoking cigarettes with varying low nicotine content up to 98 % (e.g., non-addicting) less than commercial cigarettes is not well understood. The U.S. Food and Drug Administration is considering two tobacco product standards in cigarettes including banning menthol and reducing nicotine content. These new standards have the potential to significantly reduce smoking initiation and maintenance by limiting the mechanistic effects of nicotine and menthol on the brain. METHODS: We conducted two parallel randomized clinical trials of gradually reduced nicotine in cigarettes from 11.6 mg down to 0.2 mg nicotine/cigarette (very low nicotine content; VLNC) vs. usual nicotine content (11.6 mg; UNC) over an 18-week period in people who smoke cigarettes with low socioeconomic status (SES) and mental health conditions. RESULTS: Compared to UNC, VLNC was associated with significant reductions in cotinine, cigarettes per day, expired carbon monoxide levels, nicotine dependence and symptomology. These associations did not differ between menthol and non-menthol cigarettes, except people who smoke menthol cigarettes had less of a cotinine reduction in the SES trial. The pooled odds ratio of being adherent with using only VLNC study cigarettes in the gradual nicotine reduction arm for people who smoke non-menthol vs. menthol cigarettes was 2.6 (95 % CI:1.0, 6.4; p-value: 0.04). CONCLUSIONS: When nicotine is lowered to non-addicting levels, the results indicate an independent effect of menthol on the need to sustain nicotine intake in addicted people who smoke cigarettes.


Subject(s)
Receptors, Nicotinic , Smoking Cessation , Tobacco Use Disorder , Carbon Monoxide , Cotinine , Humans , Menthol , Nicotine , Randomized Controlled Trials as Topic , Smoking Cessation/methods
14.
Article in English | MEDLINE | ID: mdl-36012024

ABSTRACT

Background: Electronic delivery systems (e.g., vapes, e-cigarettes) are now popular modes of cannabis and nicotine administration that are often used by the same individuals; however, we still know little about dual nicotine and cannabis vaping. Materials & Methods: An online convenience sample of adult nicotine and/or cannabis vape users residing in the United States completed a 60 min survey on sociodemographic characteristics, cannabis and/or nicotine vape use behaviors and dependence, reasons for vape use, and perceptions of benefits and harms. After data cleaning, we compared dual vs. nicotine-only and cannabis-only vape users with univariate statistics and step-wise hierarchical linear regression analyses. Additionally, we assessed the factor structure, internal consistency, and criterion and convergent validity of the Penn State Cannabis Vaping Dependence Index (PSCVDI). Results: The final sample included 357 dual, 40 cannabis, and 106 nicotine vape users. Compared to nicotine- and cannabis-only vapers, dual vapers started using their nicotine and cannabis vapes at a younger age (p < 0.001), used them for more years (p < 0.001), and were less likely to use their nicotine vape to replace combustible cigarettes (p = 0.047). Dual users vs. single-substance users did not have significantly higher nicotine or cannabis vape dependence scores after controlling for sociodemographic and use behaviors. The PSCVDI showed adequate validity for measuring cannabis vape dependence. Conclusions: This survey is the first to highlight important differences in vape use behaviors and reasons for use between dual vs. cannabis- and nicotine-only vape users.


Subject(s)
Cannabis , Electronic Nicotine Delivery Systems , Hallucinogens , Tobacco Products , Vaping , Adult , Humans , Nicotine , Smokers , United States/epidemiology , Vaping/epidemiology
15.
Brain Res Bull ; 188: 30-37, 2022 10 01.
Article in English | MEDLINE | ID: mdl-35901983

ABSTRACT

BACKGROUND: Many smokers report attempting to quit each year, yet most relapse, in part due to exposure to smoking-related cues. It is hypothesized that extinction of the cue-drug association could be facilitated through random nicotine delivery (RND), thus making it easier for smokers to quit. The current study aimed to evaluate the effects of RND on smoking cessation-related outcomes including cigarettes per day (CPD) and exhaled carbon monoxide (CO). METHODS: Participants were current smokers (>9 CPD) interested in quitting. Novel trans-mucosal, orally dissolving nicotine films, developed by Bionex Pharmaceuticals, were used in the study. The pharmacokinetic profile of these films was assessed in single (Experiment 1) and multiple-dose (Experiment 2) administrations prior to the smoking cessation study (Experiment 3). In Experiment 3, participants were randomized 1:1:1 to recieve 4 nicotine films per day of either: placebo delivery (0 mg), steady-state delivery (2 mg), or random nicotine delivery (RND) (0 mg or 4 mg). After two weeks, participants were advised to quit (target quit date, TQD) and were followed up 4 weeks later to collect CPD and CO and to measure dependence (Penn State Cigarette Dependence Index; PSCDI) and craving (Questionnaire of Smoking Urges; QSU-Brief). Means and frequencies were used to describe the data and repeated measures ANOVA was used to determine differences between groups. RESULTS: The pharmacokinetic studies (Experiment 1 and 2) demonstrated that the films designed for this study delivered nicotine as expected, with the 4 mg film delivering a nicotine boost of approximately 12.4 ng/mL across both the single and the multiple dose administration studies. The films reduced craving for a cigarette and were well-tolerated, overall, and caused no changes in blood pressure or heart rate. Using these films in the cessation study (Experiment 3) (n = 45), there was a significant overall reduction in cigarettes smoked per day (CPD) and in exhaled CO, with no significant differences across groups (placebo, steady-state, RND). In addition, there were no group differences in dependence or craving. Adverse events included heartburn, hiccups, nausea, and to a lesser extent, vomiting and anxiety and there were no differences across groups. CONCLUSION: Overall, this pilot study found that RND via orally dissolving films was feasible and well tolerated by participants. However, RND participants did not experience a greater reduction in self-reported CPD and exhaled CO, compared with participants in the steady-state and placebo delivery groups. Future studies to evaluate optimal RND parameters with larger sample sizes are needed to fully understand the effect of RND on smoking cessation-related outcomes.


Subject(s)
Electronic Nicotine Delivery Systems , Smoking Cessation , Tobacco Products , Humans , Nicotine , Pilot Projects , Smoke
16.
Article in English | MEDLINE | ID: mdl-35409717

ABSTRACT

Continued smoking after a cancer diagnosis is causally associated with increased risks of all-cause and cancer-specific mortality, and of smoking-related second primary cancers. Patient navigation provides individualized assistance to address barriers to smoking cessation treatment and represents a promising bridge to smoking cessation in persons with cancer who smoke cigarettes. We conducted a single-arm interventional cohort study of current smokers identified through prospective health record screening and recruited from Penn State Cancer Institute outpatient clinics. Consented participants received two telephone intervention sessions and gain-framed messaging-based smoking cessation educational materials designed for persons with cancer. The primary study outcome was the feasibility of the patient navigation-based intervention; the secondary outcome was the engagement in smoking cessation treatment at the two-month follow-up. Of 1168 unique screened Cancer Institute patients, 134 (11.5%) were identified as current cigarette smokers. Among 67 patients approached at outpatient clinics, 24 (35.8%) were interested in participating, 12 (17.9%) were enrolled, eight (11.9%) completed the intervention sessions and study assessments, and six engaged in smoking cessation treatment. The participants expressed satisfaction with the intervention sessions (median = 8.5, scale 0-10). The low recruitment rates preclude patient navigation as a feasible method for connecting cancer patients to smoking cessation treatment resources.


Subject(s)
Neoplasms , Patient Navigation , Smoking Cessation , Cohort Studies , Feasibility Studies , Humans , Prospective Studies , Smoking Cessation/methods
17.
Prev Chronic Dis ; 19: E06, 2022 02 03.
Article in English | MEDLINE | ID: mdl-35113784

ABSTRACT

INTRODUCTION: Research on electronic cigarette (e-cigarette) quit intentions and attempts is limited despite the potential health benefits of quitting, especially for long-term users. The current study aimed to investigate perceptions of harm and addictiveness and tobacco use characteristics associated with quit variables among users of a popular e-cigarette brand, JUUL. METHODS: We surveyed 301 US adult JUUL users on their tobacco use characteristics, perceptions of JUUL harm and addictiveness, and quit variables at 3 time points, from July 2019 to April 2020. We used logistic regression models to assess demographic characteristics, smoking characteristics, and perceptions of JUUL harm and addictiveness as correlates of e-cigarette quit intentions, attempts, importance, and confidence. RESULTS: Twenty-three percent of the sample had intentions to quit using JUUL within the year, and 22.6% reported making a lifetime quit attempt. The average rating of quit importance was 4.1 and quit confidence was 5.8 on a Likert scale of 1 to 10. More than 90% of the sample indicated that JUUL was at least moderately addictive, whereas less than one-quarter indicated that JUUL was as harmful or more harmful than smoking. Higher levels of perceived JUUL addictiveness were associated with more quit intentions, attempts, and importance. Higher levels of perceived JUUL harm compared with smoking were associated with more quit importance. CONCLUSION: Our findings suggest that a small proportion of adult JUUL users are interested in quitting. Self-reported perceptions of JUUL's addiction potential may be related to more quit attempts. Findings highlight the need for evidence-based information on e-cigarette addictiveness and effective strategies for cessation.


Subject(s)
Electronic Nicotine Delivery Systems , Smoking Cessation , Vaping , Adult , Humans , Intention , Smoking
18.
Addict Behav ; 127: 107220, 2022 04.
Article in English | MEDLINE | ID: mdl-34979427

ABSTRACT

Some electronic cigarette (e-cigarette) users are interested in quitting e-cigarette use, though few studies have assessed what factors contribute to this interest. This study aimed to identify factors associated with e-cigarette quitting interest and quitting behaviors in exclusive, long-term e-cigarette users. These e-cigarette users were surveyed in January 2017 (baseline) and June 2019 (follow-up), with an average follow-up period of 2.4 years. At baseline, the sample had been e-cigarette users for an average of 5.6 years. Among the 221 participants, 205 (92.8%) did not intend to quit using e-cigarettes at baseline. At follow-up, 196 (88.7%) continued exclusive e-cigarette use, 17 (7.7%) quit e-cigarettes, 8 (3.6%) became dual users, and none became exclusive smokers. At baseline, 16 users intended to quit e-cigarettes, 2 (12.5%) of whom quit at follow-up. Predictors of quitting e-cigarettes included no previous cigarette smoking (ß = -3.7, OR = 0.021, p < .01), lower Penn State Electronic Cigarette Dependence Index score (ß = -0.21, OR = 0.81, p = .011), and lower number of devices used per day (ß = -1.9, OR = 0.15, p = .015). Intending to quit e-cigarettes at baseline was not predictive of quitting at follow-up. At follow-up, 57 (25.8%) had tried to quit in the past. Overall predictors of trying to quit included interest in quitting at baseline (ß = 1.7, OR = 5.3, p < .01) and using a drip-fed atomizer (ß = 1.0, OR = 2.7, p = .022). These results suggest that long-term exclusive e-cigarette users generally have little interest in stopping e-cigarette use, and that type of device used, smoking history, e-cigarette dependence, number of devices used, and intention to quit are associated with e-cigarette quitting behaviors.


Subject(s)
Electronic Nicotine Delivery Systems , Smoking Cessation , Tobacco Products , Vaping , Humans , Smokers
19.
Nicotine Tob Res ; 24(7): 955-961, 2022 06 15.
Article in English | MEDLINE | ID: mdl-34850164

ABSTRACT

INTRODUCTION: The extent to which use of electronic nicotine delivery systems (ENDS) for smoking reduction leads to cigarette abstinence in smokers with no plans to quit smoking is unclear. This exploratory analysis examined the effects of ENDS delivering different amounts of nicotine on cigarette abstinence up to 24-week follow-up, in comparison to placebo or a behavioral substitute. METHODS: This four-arm parallel-group, randomized, placebo-controlled trial took place at two academic medical centers in the United States (Penn State Hershey and Virginia Commonwealth University). Participants were current adult smokers (N = 520) interested in reducing but not planning to quit. They received brief advice and were randomized to one of four 24-week conditions, receiving either an eGo-style ENDS paired with 0, 8, or 36 mg/ml nicotine liquid (double-blind) or a cigarette-shaped tube, as a cigarette substitute (CS). Self-reported daily cigarette consumption and exhaled carbon monoxide (CO) were measured at all study visits. Outcomes included intent-to-treat, self-reported 7-day cigarette abstinence, biochemically confirmed by exhaled CO at 24 weeks after randomization. RESULTS: At 24 weeks, significantly more participants in the 36 mg/ml condition (14/130, 10.8%) than in the 0 mg/ml condition (1/130, 0.8%) and the CS condition (4/130, 3.1%) were abstinent (relative risk = 14 [95% CI = 1.9-104.9] and 3.5 [95% CI = 1.2-10.4], respectively). The abstinence rate in the 8 mg/ml condition was 4.6% (6/130). CONCLUSIONS: When smokers seeking to reduce smoking tried ENDS, few quit smoking in the short term. However, if smokers continued to use an ENDS with cigarette-like nicotine delivery, a greater proportion completely switched to ENDS, as compared with placebo or a cigarette substitute. IMPLICATIONS: The extent to which use of electronic nicotine delivery systems (ENDS) for smoking reduction leads to cigarette abstinence in smokers with no plans to quit smoking was unclear. This randomized trial found that ENDS with nicotine delivery approaching that of a cigarette are more effective in helping ambivalent smokers to quit cigarette smoking.


Subject(s)
Electronic Nicotine Delivery Systems , Smoking Cessation , Tobacco Products , Adult , Humans , Nicotine , Smokers , United States
20.
Exp Clin Psychopharmacol ; 30(6): 947-958, 2022 Dec.
Article in English | MEDLINE | ID: mdl-34110883

ABSTRACT

Regulations limiting the sale of flavored e-cigarette products are controversial for their potential to interfere with e-cigarette use as a cessation aid in addition to curbing youth use. Limited research suggests that flavor might enhance the addictive potential of e-cigarettes; however, the acute effects of flavored aerosols on brain function among humans have not been assessed. The present study aimed to isolate and compare the neural substrates of flavored and unflavored e-cigarette aerosols on brain function among nine female daily smokers. Participants inhaled aerosolized e-liquid with 36 mg/mL of nicotine with and without a strawberry-vanilla flavor while undergoing functional magnetic resonance imaging. We used general linear modeling to compare whole-brain mean neural activation and seed-to-voxel task-based functional connectivity between the flavored and unflavored inhalation runs. Contrary to our hypothesis, the flavored aerosol was associated with weaker activation than the unflavored aerosol in the brain stem and bilateral parietal-temporal-occipital region of the cortex. Instead, the flavor engaged taste-related brain regions while suppressing activation of the neural circuits typically engaged during smoking and nicotine administration. Alternatively, functional connectivity between subcortical dopaminergic brain seeds and cortical brain regions involved in motivation and reward salience were stronger during the flavored compared to unflavored aerosol run. The findings suggest that fruity and dessert-flavored e-cigarettes may dampen the reward experience of aerosol inhalation for smokers who initiate e-cigarette use by inhibiting activation of dopaminergic brain circuits. These preliminary findings may have implications for understanding how regulations on flavored e-cigarettes might impact their use as cessation aids. (PsycInfo Database Record (c) 2022 APA, all rights reserved).


Subject(s)
Electronic Nicotine Delivery Systems , Tobacco Products , Adolescent , Humans , Female , Smokers , Nicotine , Taste , Magnetic Resonance Imaging , Flavoring Agents , Brain
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