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Jennifer W Tidey - One of the best experts on this subject based on the ideXlab platform.

  • effects of reduced Nicotine Content cigarettes on fractional exhaled nitric oxide feno and self reported respiratory health outcomes among smokers with psychiatric conditions or socioeconomic disadvantage
    Nicotine & Tobacco Research, 2021
    Co-Authors: Anthony C Oliver, Jennifer W Tidey, Diann E Gaalema, Stacey C Sigmon, Sarah H Heil, Michael J Desarno, Dustin C Lee, Charles G Irvin, David A Kaminsky, Janice Y Bunn
    Abstract:

    INTRODUCTION This study examined whether exposure to reduced-Nicotine-Content cigarettes (RNCCs) for 12 weeks alters respiratory health using Fractional Exhaled Nitric Oxide (FeNO), a validated biomarker of respiratory epithelial health, and the Respiratory Health Questionnaire (RHQ), a subject-rated questionnaire on respiratory symptoms. Participants were 747 adult daily smokers enrolled in three double-blind, randomized clinical trials evaluating effects of cigarette Nicotine Content (0.4, 2.4, 15.8 mg Nicotine/g tobacco) in people with affective disorders, opioid use disorder (OUD), or socioeconomic disadvantage. METHOD FeNO levels and RHQ ratings were collected at baseline and Weeks 6 and 12 following randomization. Multiple regression was used to assess associations of FeNO and RHQ with smoking characteristics. Mixed-model repeated-measures ANOVA was used to evaluate effects of Nicotine Content on FeNO and RHQ outcomes over the 12-week study period. RESULTS FeNO levels but not RHQ ratings varied inversely with smoking characteristics at baseline (Ps<0.0001) in smokers with affective disorders and socioeconomic disadvantage but less so in those with OUD. Participants with affective disorders and socioeconomic disadvantage, but not those with OUD, who were assigned to RNCCs had higher FeNO levels at Week 12 than those assigned to the 15.8 mg/g dose (F[2,423]=4.51, p=0.01, Cohen d=0.21). No significant dose-related changes in RHQ scores were identified. CONCLUSION Use of RNCCs across a 12-week period attenuates smoking-related reductions in FeNO levels in smokers with affective disorders and socioeconomic disadvantage although not those with OUD. FeNO changes were not accompanied by changes in respiratory-health ratings. IMPLICATIONS Should a reduced Nicotine Content standard be implemented; these results suggest that reduced Nicotine Content in cigarettes will not exacerbate and instead may attenuate smoking-related decreases in FeNO. This is significant as NO is an important component in maintaining a healthy respiratory system and necessary to defend against infection. Furthermore, the results of the current study demonstrate that the adoption of the reduced Nicotine Content standard may result in beneficial impacts on respiratory epithelial health among vulnerable populations that are disproportionally affected by the adverse health outcomes precipitated by combustible tobacco use.

  • support for a Nicotine reduction policy among participants enrolled in a 20 week trial of very low Nicotine Content cigarettes
    Addictive Behaviors, 2021
    Co-Authors: Rachel L Denlingerapte, Joseph S Koopmeiners, Jennifer W Tidey, Lauren R Pacek, Tracy T Smith, Joni Jensen, Joseph F Mcclernon, Xianghua Luo, Suzanne M Colby, Herbert H Severson
    Abstract:

    Abstract Introduction The Food and Drug Administration is considering a policy to drastically reduce the allowable Nicotine Content of cigarettes. The current study examined whether the policy implementation approach, i.e., either immediately reducing Nicotine Content to very low levels or gradually reducing Nicotine Content over an extended period, influences policy support among people who smoke cigarettes. Methods Adults who smoked daily were randomly assigned (double-blind) to an immediate Nicotine reduction condition (0.4 mg/g Nicotine cigarettes), a gradual Nicotine reduction condition (15.5 to 0.4 mg/g), or a control condition (15.5 mg/g) for 20 weeks. Participants were asked if they would “support or oppose a law that reduced the amount of Nicotine in cigarettes, to make cigarettes less addictive.” Logistic regression analyses assessed if policy support was affected by treatment condition, demographic covariates, interest in quitting, and subjective cigarette effects. Results At Week 20 (N = 957 completers), 60.4% of participants supported the policy, 17.4% opposed, and 22.2% responded “Don’t know.” Policy support did not differ by treatment condition. Support was greater among those interested in quitting (OR = 3.37, 95% CI = 2.49, 4.55). Support was lower among males (OR = 0.49, 95% CI = 0.37, 0.67), those with greater dependence scores (OR = 0.92, 95% CI = 0.86, 0.99) and participants aged 18–24 (OR = 0.53, 95% CI = 0.28, 0.99). No other covariates were associated with policy support. Conclusions The majority of participants supported a Nicotine reduction policy. The implementation approach, immediate or gradual reduction, did not affect policy support. Participants interested in quitting smoking were more likely to support a Nicotine reduction policy.

  • changes in cigarette consumption with reduced Nicotine Content cigarettes among smokers with psychiatric conditions or socioeconomic disadvantage 3 randomized clinical trials
    JAMA Network Open, 2020
    Co-Authors: Stephen T Higgins, Jennifer W Tidey, John R. Hughes, Andrea C Villanti, Diann E Gaalema, Stacey C Sigmon, Sarah H Heil, Janice Y Bunn, Dustin Lee, Danielle R Davis
    Abstract:

    Importance This study is part of a programmatic effort evaluating the effects of reducing Nicotine Content of cigarettes to minimally addictive levels. Objective To examine whether very low-Nicotine-Content (VLNC) cigarettes decrease smoking rates and dependence severity among smokers with psychiatric disorders or socioeconomic disadvantage. Design, Setting, and Participants These 3 randomized clinical trials were performed at the University of Vermont, Brown University, and Johns Hopkins University between October 2016 and September 2019. Participants received 12 weeks of exposure to study cigarettes with Nicotine Content ranging from levels representative of commercial cigarettes (15.8 mg Nicotine/g tobacco) to less than a hypothesized addiction threshold (2.4 mg/g and 0.4 mg/g). Daily smokers from 3 at-risk populations participated: individuals with affective disorders, exemplifying smokers with mental illness; individuals with opioid use disorder, exemplifying smokers with substance use disorders; and women with high school educations or less, exemplifying smokers with socioeconomic disadvantage. Data were analyzed from September 2019 to July 2020. Interventions Random assignment to 1 of 3 study cigarettes provided weekly at no cost for 12 weeks. Main Outcomes and Measures The primary outcome was between-group differences in mean total cigarettes smoked daily (CPD) during week 12; secondary outcomes included CPD for study and nonstudy cigarettes and dependence severity across weeks analyzed using analysis of covariance, random coefficients growth modeling, or repeated measures analysis of variance. Results A total of 775 participants were included (mean [SD] age, 35.59 [11.05] years; 551 [71.10%] women [owing to 1 population being exclusively women]); participants smoked a mean (SD) of 17.79 (9.18) CPD at study intake. A total of 286 participants were randomized to 0.4 mg/g, 235 participants were randomized to 2.4 mg/g, and 254 participants were randomized to 15.8 mg/g. Participants randomized to VLNC cigarettes had decreased mean [SEM] total CPD during week 12 across populations (Cohen d = 0.61; P < .001). At week 12, mean (SEM) CPD decreased to 17.96 (0.98) CPD in the 0.4 mg/g group and to 19.53 (1.07) CPD in the 2.4 mg/g group, both of which were significantly different from the 15.8 mg/g group (25.08 [1.08] CPD at week 12) but not each other (0.4 mg/g adjusted mean difference: -7.54 [95%CI, -9.51 to -5.57]; 2.4 mg/g adjusted mean difference: -5.34 [95% CI, 7.41 to -3.26]). Several secondary outcomes differed across populations randomized to VLNCs, including mean total CPD across weeks, with linear trends lower in participants receiving 0.4 mg/g (-0.28 [95%CI, -0.39 to -0.18]; P < .001) and 2.4 mg/g (-0.13 [95%CI, -0.25 to -0.01]; P < .001) doses compared with those receiving the 15.8 mg/g dose (0.30 [95% CI, 0.19 to 0.41]). Fagerstrom Test of Nicotine Dependence mean total scores were significantly lower in participants who received VLNCs (Cohen d = 0.12; P < .001), with those who received the 0.4 mg/g dose (mean [SD] score, 3.99 [0.06]; P < .001 vs 15.8 mg/g) or 2.4 mg/g dose (mean [SD] score, 4.07 [0.06]; P = .01 vs 15.8 mg/g) differing from those who received the 15.8 mg/g dose (mean [SD] score, 4.31 [0.06]) but not from each other. Conclusions and Relevance These findings demonstrate that decreasing the Nicotine Content of cigarettes to very low levels reduced smoking rate and Nicotine-dependence severity in these high-risk populations, effects that may facilitate successful cessation. Trial Registration ClinicalTrials.gov Identifiers: NCT02232737, NCT02250664, NCT02250534.

  • smoking topography characteristics during a 6 week trial of very low Nicotine Content cigarettes in smokers with serious mental illness
    Nicotine & Tobacco Research, 2020
    Co-Authors: Rachel L Denlingerapte, Dorothy K Hatsukami, Eric C Donny, Suzanne M Colby, Patricia A Cioe, Christine Goodwin, Bruce R Lindgren, Nathan Rubin, Teresa Deatley, Jennifer W Tidey
    Abstract:

    INTRODUCTION A Nicotine-reduction policy could have major benefits for smokers with serious mental illness (SMI). However, potential unintended consequences, such as compensatory smoking, should be considered to ensure that such a policy does not negatively affect this population. The purpose of this secondary analysis was to examine the impact of smoking very low Nicotine Content (VLNC) cigarettes for 6 weeks on smoking topography characteristics, indicators of compensatory smoking, among smokers with SMI. AIMS AND METHODS After a baseline usual brand smoking phase, smokers with SMI (N = 58) were randomly assigned under double-blind conditions to receive either VLNC (0.4 mg Nicotine per g tobacco) or normal Nicotine Content (NNC; 15.8 mg Nicotine per g tobacco) research cigarettes for 6 weeks. During two study visits scheduled 6 weeks apart, participants smoked either their usual brand (baseline) or assigned study cigarettes (postrandomization) through a handheld smoking topography device. Univariate analysis of variance compared smoking topography indices with cigarette condition (VLNC vs. NNC) as the between-subjects factor with corresponding baseline topography results included as covariates. RESULTS At week 6, participants in the VLNC condition smoked fewer puffs per cigarette and had shorter interpuff intervals compared to participants in the NNC condition (ps < .05). There were no differences between research cigarette conditions at week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost. CONCLUSIONS Findings are consistent with acute VLNC cigarette topography studies and indicate that a Nicotine-reduction policy is unlikely to lead to compensation among smokers with SMI. IMPLICATIONS Given the high smoking rates among people with SMI, understanding how a Nicotine-reduction policy may affect this population is critically important. When considering the smoking topography results as a whole, smokers with SMI did not engage in compensatory smoking behavior when using VLNC cigarettes during a 6-week trial. Study findings suggest that compensatory smoking is not likely to occur among smokers with SMI if Nicotine Content is lowered to minimally addictive levels.

  • potential moderating effects of sex gender on the acute relative reinforcing and subjective effects of reduced Nicotine Content cigarettes in vulnerable populations
    Nicotine & Tobacco Research, 2020
    Co-Authors: Joanna M Streck, Jennifer W Tidey, Danielle R Davis, Diann E Gaalema, Stacey C Sigmon, Sarah H Heil, Cecilia L Bergeria, Janice Y Bunn, Raina D Pang, John R. Hughes
    Abstract:

    Author(s): Streck, Joanna M; Davis, Danielle R; Pang, Raina D; Sigmon, Stacey C; Bunn, Janice Y; Bergeria, Cecilia L; Tidey, Jennifer W; Heil, Sarah H; Gaalema, Diann E; Hughes, John R; Stitzer, Maxine L; Reed, Ellaina; Higgins, Stephen T | Abstract: IntroductionReports in relatively healthy smokers suggest men are more sensitive than women to the subjective effects of reduced Nicotine Content cigarettes (RNCCs). We know of no reports examining sex differences in the relative reinforcing effects of RNCCs, an important outcome in assessing smoking's addiction potential. The aim of the present study is to address this gap by examining sex/gender differences on reinforcing effects while examining whether sex differences in subjective effects are discernible in vulnerable populations.MethodsSecondary analysis of a within-subject, double-blinded experiment examining acute effects of cigarettes varying in Nicotine Content (0.4, 2.4, 5.2, 15.8 mg/g) among 169 adult smokers with psychiatric conditions or socioeconomic disadvantage. Effects of dose, sex, and their interaction were examined on reinforcing (concurrent-choice and Cigarette Purchase Task [CPT] testing), and subjective effects (Cigarette Evaluation Questionnaire [CEQ] and craving/withdrawal ratings).ResultsReducing Nicotine Content decreased the relative reinforcing effects of smoking in concurrent-choice and CPT testing (p's l .05) with no significant effects of sex nor dose × sex/gender interactions. Reducing Nicotine Content decreased CEQ ratings with only a single significant effect of sex (higher Psychological Reward scores among women than men, p = .02) and no significant dose × sex/gender interactions. Results on craving/withdrawal paralleled those on the CEQ.ConclusionsReducing Nicotine Content decreases the addiction potential of smoking independent of sex in populations highly vulnerable to smoking and addiction, with no indication that women are less sensitive to subjective effects of RNCCs or would benefit less from a policy reducing the Nicotine Content of cigarettes.ImplicationsA policy reducing the Nicotine Content of cigarettes has the potential to reduce the addiction potential of smoking across men and women who are especially vulnerable to smoking, addiction, and tobacco-related adverse health impacts.

Eric C Donny - One of the best experts on this subject based on the ideXlab platform.

  • reactions to reduced Nicotine Content cigarettes in a sample of young adult low frequency smokers
    Psychopharmacology, 2021
    Co-Authors: Maggie M Sweitzer, Lauren R Pacek, Eric C Donny, Rachel V Kozink, Erin N Locey, Scott H Kollins, Joseph F Mcclernon
    Abstract:

    Reducing Nicotine Content in cigarettes to ≤ 2.4 mg per g of tobacco [mg/g] reduces smoking behavior and toxicant exposure among adult daily smokers. However, cigarettes with similar Nicotine Content could support continued experimentation and smoking progression among young adults who smoke infrequently. This study evaluated the threshold for Nicotine in cigarettes that produces reactions associated with smoking progression in a sample of young adults who smoke infrequently. Young adults (n = 87, 18–25 years, 49% female) using tobacco products ≤ 15 days per month completed three counterbalanced, double-blinded sessions, each measuring positive and negative subjective reactions to fixed doses of smoke from investigational cigarettes containing one of three different Nicotine Contents: normal (NNC; 15.8 mg/g); very low (VLNC; 0.4 mg/g); and intermediate (INC; 2.4 mg/g). In a final session, participants chose one of the cigarettes to self-administer. Post-cigarette breath carbon monoxide was greater for VLNC than for NNC (p < 0.001). Positive reactions were greater for NNC than INC (p < 0.001) and for INC than VLNC (p = 0.001). Negative reactions were greater for NNC than INC and VLNC (both p < 0.001); INC and VLNC did not differ. Cigarette choices did not differ from an even distribution (43% NNC, 25% INC, 32% VLNC), but choice for NNC or INC was associated with higher ratio of positive to negative reactions during the NNC and INC fixed dose sessions, respectively (p < 0.001). Reducing Nicotine Content will likely lower the abuse liability of cigarettes for most young, low-frequency smokers. Additional work is needed to determine if compensatory smoking may lead to increased toxicant exposure, and if a subset of individuals choosing lower Nicotine cigarettes may continue to smoke regardless of Nicotine Content.

  • i actually finally feel like the cigarettes aren t controlling me interviews with participants smoking very low Nicotine Content cigarettes during a residential study
    Drug and Alcohol Dependence, 2021
    Co-Authors: Rachel L Denlingerapte, Neal L. Benowitz, Dorothy K Hatsukami, Eric C Donny, Cassidy M White, Matthew J Carpenter, Tracy T Smith
    Abstract:

    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.

  • smoking topography characteristics during a 6 week trial of very low Nicotine Content cigarettes in smokers with serious mental illness
    Nicotine & Tobacco Research, 2020
    Co-Authors: Rachel L Denlingerapte, Dorothy K Hatsukami, Eric C Donny, Suzanne M Colby, Patricia A Cioe, Christine Goodwin, Bruce R Lindgren, Nathan Rubin, Teresa Deatley, Jennifer W Tidey
    Abstract:

    INTRODUCTION A Nicotine-reduction policy could have major benefits for smokers with serious mental illness (SMI). However, potential unintended consequences, such as compensatory smoking, should be considered to ensure that such a policy does not negatively affect this population. The purpose of this secondary analysis was to examine the impact of smoking very low Nicotine Content (VLNC) cigarettes for 6 weeks on smoking topography characteristics, indicators of compensatory smoking, among smokers with SMI. AIMS AND METHODS After a baseline usual brand smoking phase, smokers with SMI (N = 58) were randomly assigned under double-blind conditions to receive either VLNC (0.4 mg Nicotine per g tobacco) or normal Nicotine Content (NNC; 15.8 mg Nicotine per g tobacco) research cigarettes for 6 weeks. During two study visits scheduled 6 weeks apart, participants smoked either their usual brand (baseline) or assigned study cigarettes (postrandomization) through a handheld smoking topography device. Univariate analysis of variance compared smoking topography indices with cigarette condition (VLNC vs. NNC) as the between-subjects factor with corresponding baseline topography results included as covariates. RESULTS At week 6, participants in the VLNC condition smoked fewer puffs per cigarette and had shorter interpuff intervals compared to participants in the NNC condition (ps < .05). There were no differences between research cigarette conditions at week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost. CONCLUSIONS Findings are consistent with acute VLNC cigarette topography studies and indicate that a Nicotine-reduction policy is unlikely to lead to compensation among smokers with SMI. IMPLICATIONS Given the high smoking rates among people with SMI, understanding how a Nicotine-reduction policy may affect this population is critically important. When considering the smoking topography results as a whole, smokers with SMI did not engage in compensatory smoking behavior when using VLNC cigarettes during a 6-week trial. Study findings suggest that compensatory smoking is not likely to occur among smokers with SMI if Nicotine Content is lowered to minimally addictive levels.

  • age moderates smokers subjective response to very low Nicotine Content cigarettes evidence from a randomized controlled trial
    Nicotine & Tobacco Research, 2019
    Co-Authors: Rachel N Cassidy, Joseph S Koopmeiners, Jennifer W Tidey, Dorothy K Hatsukami, Suzanne M Colby, Qing Cao, Francis J Mcclernon, Eric C Donny
    Abstract:

    Introduction Reducing the level of Nicotine in cigarettes is a regulatory strategy that has the potential to greatly improve public health. If Nicotine levels are reduced in all commercially available cigarettes, current smokers might find it easier to quit and young people might be less likely to become dependent. However, it is not yet known whether age moderates subjective or behavioral responses to low-Nicotine cigarettes. Methods Recently, a large, multisite randomized clinical trial was conducted to compare the effects of cigarettes differing in Nicotine Content (either usual-brand or research cigarettes containing 15.8, 5.2, 2.4, 1.3, or 0.4 mg Nicotine/g tobacco) across 6 weeks of exposure. In this secondary analysis, we tested whether age moderated smokers' subjective (measures of psychological reward, smoking satisfaction) and behavioral (cigarettes smoked per day, smoking topography, and Nicotine exposure) responses to cigarettes varying in Nicotine Content after 2 and 6 weeks of use, while controlling for baseline dependence and demographic factors. Results Results indicated that younger adults (age 18-24) who smoked cigarettes with 2.4-0.4 mg/g Nicotine reported significantly less smoking satisfaction and psychological reward, and smoked fewer cigarettes per day, than older adults (25+ years) after 2 weeks of use. No differences in topography were observed at either time point. After 6 weeks of use, differences had diminished on all measures. Conclusions The reduced positive effects of reduced-Nicotine Content cigarettes in young adults suggests that this regulatory policy may reduce smoking reinforcement in this vulnerable population. Implications As the FDA considers reducing the level of Nicotine in cigarettes to make them less addictive, understanding the potential impact of this policy on young people is of crucial importance. We found that young adults had significantly lower positive subjective effects to very-low Nicotine Content (VLNC) cigarettes and smoked fewer VLNC cigarettes than older adults after 2 weeks of use, indicating that this policy may reduce smoking reinforcement more quickly in young adults. These data add to the growing body of evidence on the potential for this policy to positively affect public health.

  • effects of reduced Nicotine Content cigarettes on individual withdrawal symptoms over time and during abstinence
    Experimental and Clinical Psychopharmacology, 2018
    Co-Authors: Sarah S Dermody, Jennifer W Tidey, Tracy T Smith, Neal L. Benowitz, Dorothy K Hatsukami, Joseph F Mcclernon, Ryan Vandrey, Xianghua Luo, Eric C Donny
    Abstract:

    In the United States, the Food and Drug Administration (FDA) has initiated a public dialogue about reducing the Nicotine Content of cigarettes. A reduced-Nicotine standard could increase withdrawal symptoms among current smokers. We examined the impact of switching smokers to cigarettes that varied in Nicotine Content on withdrawal symptoms over 6 weeks. A secondary analysis (N = 839) of a 10-site, double-blind clinical trial of nontreatment-seeking smokers was completed. Participants were instructed to smoke study cigarettes, containing 0.4 to 15.8 mg of Nicotine/g of tobacco, for 6 weeks and were then abstinent overnight. Using latent growth curves, trajectories of individual withdrawal symptoms were compared between the reduced Nicotine Content (RNC) conditions and a normal Nicotine Content (NNC) condition. Path analyses compared symptoms after overnight abstinence. Relative to NNC cigarettes, participants smoking RNC cigarettes had increased anger/irritability/frustration and increased appetite/weight gain during the initial weeks, but the symptoms resolved by Week 6. Individuals who were biochemically verified as adherent with using only the 0.4 mg/g cigarettes had higher sadness levels (Cohen's d = .40) at Week 6 compared with the NNC condition, although symptoms were mild. After a post-Week 6 overnight abstinence challenge, some RNC conditions relative to NNC condition exhibited reduced withdrawal. Individuals who were biochemically confirmed as adherent to the lowest Nicotine condition experienced only mild and transient symptom elevations. Thus, a reduced-Nicotine standard for cigarettes produced a relatively mild and temporary increase in withdrawal among nontreatment-seeking smokers (ClinicalTrials.gov No. NCT01681875). (PsycINFO Database Record

Neal L. Benowitz - One of the best experts on this subject based on the ideXlab platform.

  • i actually finally feel like the cigarettes aren t controlling me interviews with participants smoking very low Nicotine Content cigarettes during a residential study
    Drug and Alcohol Dependence, 2021
    Co-Authors: Rachel L Denlingerapte, Neal L. Benowitz, Dorothy K Hatsukami, Eric C Donny, Cassidy M White, Matthew J Carpenter, Tracy T Smith
    Abstract:

    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.

  • effects of very low Nicotine Content cigarettes on smoking behavior and biomarkers of exposure in menthol and non menthol smokers
    Nicotine & Tobacco Research, 2019
    Co-Authors: Rachel L Denlingerapte, Michael Kotlyar, Joseph S Koopmeiners, Jennifer W Tidey, Joshua O Ikuemonisan, Lauren R Pacek, Joni Jensen, Neal L. Benowitz, Tracy T Smith
    Abstract:

    Author(s): Denlinger-Apte, Rachel L; Kotlyar, Michael; Koopmeiners, Joseph S; Tidey, Jennifer W; Luo, Xianghua; Benowitz, Neal L; Jensen, Joni A; Ikuemonisan, Joshua O; Pacek, Lauren R; Smith, Tracy T; Vandrey, Ryan; Donny, Eric C; Hatsukami, Dorothy K | Abstract: INTRODUCTION:Because 30% of cigarettes sold in the United States are characterized as menthol cigarettes, it is important to understand how menthol preference may affect the impact of a Nicotine reduction policy. METHODS:In a recent trial, non-treatment-seeking smokers were randomly assigned to receive very low Nicotine cigarettes (VLNC; 0.4 mg Nicotine/g tobacco) or normal Nicotine cigarettes (NNC; 15.5 mg/g) for 20 weeks. On the basis of preference, participants received menthol or non-menthol cigarettes. We conducted multivariable regression analyses to examine whether menthol preference moderated the effects of Nicotine Content on cigarettes per day (CPD), breath carbon monoxide (CO), urinary total Nicotine equivalents (TNE), urinary 2-cyanoethylmercapturic acid (CEMA), and abstinence. RESULTS:At baseline, menthol smokers (n = 346) reported smoking fewer CPD (14.9 vs. 19.2) and had lower TNE (52.8 vs. 71.6 nmol/mg) and CO (17.7 vs. 20.5 ppm) levels than non-menthol smokers (n = 406; ps l .05). At week 20, significant interactions indicated that menthol smokers had smaller treatment effects than non-menthol smokers for CPD (-6.4 vs. -9.3), TNE (ratio of geometric means, 0.22 vs. 0.10) and CEMA (ratio, 0.56 vs. 0.37; ps l .05), and trended toward a smaller treatment effect for CO (-4.5 vs. -7.3 ppm; p = .06). Odds ratios for abstinence at week 20 were 1.88 (95% confidence interval [CI] = 0.8 to 4.4) for menthol and 9.11 (95% CI = 3.3 to 25.2) for non-menthol VLNC smokers (p = .02) relative to the NNC condition. CONCLUSIONS:Although menthol smokers experienced reductions in smoking, toxicant exposure, and increases in quitting when using VLNC cigarettes, the magnitude of change was smaller than that observed for non-menthol smokers. IMPLICATIONS:Results of this analysis suggest that smokers of menthol cigarettes may respond to a Nicotine reduction policy with smaller reductions in smoking rates and toxicant exposure than would smokers of non-menthol cigarettes.

  • association of reduced Nicotine Content cigarettes with smoking behaviors and biomarkers of exposure among slow and fast Nicotine metabolizers a nonrandomized clinical trial
    JAMA Network Open, 2018
    Co-Authors: Melissa Mercincavage, Neal L. Benowitz, Kirsten Lochbuehler, Paul E Wileyto, Rachel F Tyndale, Caryn Lerman, Andrew A Strasser
    Abstract:

    Importance The US Food and Drug Administration (FDA) has announced its intention to reduce the Nicotine Content in combustible cigarettes but must base regulation on public health benefits. Fast Nicotine metabolizers may be at risk for increased smoking following a national Nicotine reduction policy. We hypothesized that using reduced Nicotine Content (RNC) cigarettes would be associated with increases in smoking behaviors and exposure among smokers with a fast—but not slow—Nicotine-metabolite ratio (NMR). Objectives To examine the association of RNC cigarettes with smoking behaviors and biomarkers of exposure and to compare these associations in fast and slow metabolizers of Nicotine based on the NMR. Design, Setting, and Participants A 35-day, 3-period, within-participant nonrandomized clinical trial was conducted at an academic medical center in Philadelphia, Pennsylvania. A 5-day baseline period using the smokers’ preferred brand of cigarettes was followed by 2 consecutive 15-day periods using free investigational RNC cigarettes. A total of 100 daily, non–treatment-seeking, nonmenthol cigarette smokers (59 fast, 41 slow metabolizers) were recruited from December 24, 2013, to December 2, 2015. Data analysis was performed from December 12, 2016, to January 3, 2018. Interventions Two 15-day periods using cigarettes containing 5.2 mg (RNC1) and 1.3 mg (RNC2) of Nicotine per gram of tobacco. Main Outcomes and Measures Smoking behaviors (number of cigarettes per day [CPD], total puff volume) and biomarkers of exposure (carbon monoxide [CO], urine total Nicotine equivalents [TNE], and 4-[methylnitrosamino]-1-[3-pyridyl]-1-butanol [NNAL]). Results Smokers (73 [73.0%] men; 74 [74.0%] white; mean [SD] age, 43.02 [12.13] years; mean [SD] CPD, 17.31 [5.72]) consumed 2.62 (95% CI, 1.54-3.70) more CPD during the RNC1 period vs their preferred brand during baseline (P  Conclusions and Relevance Both RNC cigarettes were associated with decreased puffing and urinary biomarker exposure but not with decreased daily cigarette consumption or CO levels. The NMR did not moderate associations at the Nicotine levels tested, suggesting that fast metabolizers may not be at greater risk of increasing use or exposure from these products should the FDA mandate an RNC standard for cigarettes. Trial Registration ClinicalTrials.gov identifier:NCT01898507

  • effects of reduced Nicotine Content cigarettes on individual withdrawal symptoms over time and during abstinence
    Experimental and Clinical Psychopharmacology, 2018
    Co-Authors: Sarah S Dermody, Jennifer W Tidey, Tracy T Smith, Neal L. Benowitz, Dorothy K Hatsukami, Joseph F Mcclernon, Ryan Vandrey, Xianghua Luo, Eric C Donny
    Abstract:

    In the United States, the Food and Drug Administration (FDA) has initiated a public dialogue about reducing the Nicotine Content of cigarettes. A reduced-Nicotine standard could increase withdrawal symptoms among current smokers. We examined the impact of switching smokers to cigarettes that varied in Nicotine Content on withdrawal symptoms over 6 weeks. A secondary analysis (N = 839) of a 10-site, double-blind clinical trial of nontreatment-seeking smokers was completed. Participants were instructed to smoke study cigarettes, containing 0.4 to 15.8 mg of Nicotine/g of tobacco, for 6 weeks and were then abstinent overnight. Using latent growth curves, trajectories of individual withdrawal symptoms were compared between the reduced Nicotine Content (RNC) conditions and a normal Nicotine Content (NNC) condition. Path analyses compared symptoms after overnight abstinence. Relative to NNC cigarettes, participants smoking RNC cigarettes had increased anger/irritability/frustration and increased appetite/weight gain during the initial weeks, but the symptoms resolved by Week 6. Individuals who were biochemically verified as adherent with using only the 0.4 mg/g cigarettes had higher sadness levels (Cohen's d = .40) at Week 6 compared with the NNC condition, although symptoms were mild. After a post-Week 6 overnight abstinence challenge, some RNC conditions relative to NNC condition exhibited reduced withdrawal. Individuals who were biochemically confirmed as adherent to the lowest Nicotine condition experienced only mild and transient symptom elevations. Thus, a reduced-Nicotine standard for cigarettes produced a relatively mild and temporary increase in withdrawal among nontreatment-seeking smokers (ClinicalTrials.gov No. NCT01681875). (PsycINFO Database Record

  • reducing Nicotine exposure results in weight gain in smokers randomised to very low Nicotine Content cigarettes
    Tobacco Control, 2017
    Co-Authors: Laura E Rupprecht, Mustafa Alabsi, Joseph S Koopmeiners, Rachel L Denlingerapte, Neal L. Benowitz, Dorothy K Hatsukami, Sarah S Dermody, David J Drobes, Jason A Oliver, Joseph F Mcclernon
    Abstract:

    Background The Food and Drug Administration can reduce the Nicotine Content in cigarettes to very low levels. This potential regulatory action is hypothesised to improve public health by reducing smoking, but may have unintended consequences related to weight gain. Methods Weight gain was evaluated from a double-blind, parallel, randomised clinical trial of 839 participants assigned to smoke 1 of 6 investigational cigarettes with Nicotine Content ranging from 0.4 to 15.8 mg/g or their own usual brand for 6 weeks. Additional analyses evaluated weight gain in the lowest Nicotine Content cigarette groups (0.4 and 0.4 mg/g, high tar) to examine the effect of study product in compliant participants as assessed by urinary biomarkers. Differences in outcomes due to gender were also explored. Findings There were no significant differences in weight gain when comparing the reduced Nicotine conditions with the 15.8 mg/g control group across all treatment groups and weeks. However, weight gain at week 6 was negatively correlated with Nicotine exposure in the 2 lowest Nicotine Content cigarette conditions. Within the 2 lowest Nicotine Content cigarette conditions, male and female smokers biochemically verified to be compliant on study product gained significantly more weight than non-compliant smokers and control groups. Conclusions The effect of random assignment to investigational cigarettes with reduced Nicotine on weight gain was likely obscured by non-compliance with study product. Men and women who were compliant in the lowest Nicotine Content cigarette conditions gained 1.2 kg over 6 weeks, indicating weight gain is a likely consequence of reduced exposure to Nicotine. Trial registration number NCT01681875, Post-results.

Dorothy K Hatsukami - One of the best experts on this subject based on the ideXlab platform.

  • i actually finally feel like the cigarettes aren t controlling me interviews with participants smoking very low Nicotine Content cigarettes during a residential study
    Drug and Alcohol Dependence, 2021
    Co-Authors: Rachel L Denlingerapte, Neal L. Benowitz, Dorothy K Hatsukami, Eric C Donny, Cassidy M White, Matthew J Carpenter, Tracy T Smith
    Abstract:

    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.

  • smoking topography characteristics during a 6 week trial of very low Nicotine Content cigarettes in smokers with serious mental illness
    Nicotine & Tobacco Research, 2020
    Co-Authors: Rachel L Denlingerapte, Dorothy K Hatsukami, Eric C Donny, Suzanne M Colby, Patricia A Cioe, Christine Goodwin, Bruce R Lindgren, Nathan Rubin, Teresa Deatley, Jennifer W Tidey
    Abstract:

    INTRODUCTION A Nicotine-reduction policy could have major benefits for smokers with serious mental illness (SMI). However, potential unintended consequences, such as compensatory smoking, should be considered to ensure that such a policy does not negatively affect this population. The purpose of this secondary analysis was to examine the impact of smoking very low Nicotine Content (VLNC) cigarettes for 6 weeks on smoking topography characteristics, indicators of compensatory smoking, among smokers with SMI. AIMS AND METHODS After a baseline usual brand smoking phase, smokers with SMI (N = 58) were randomly assigned under double-blind conditions to receive either VLNC (0.4 mg Nicotine per g tobacco) or normal Nicotine Content (NNC; 15.8 mg Nicotine per g tobacco) research cigarettes for 6 weeks. During two study visits scheduled 6 weeks apart, participants smoked either their usual brand (baseline) or assigned study cigarettes (postrandomization) through a handheld smoking topography device. Univariate analysis of variance compared smoking topography indices with cigarette condition (VLNC vs. NNC) as the between-subjects factor with corresponding baseline topography results included as covariates. RESULTS At week 6, participants in the VLNC condition smoked fewer puffs per cigarette and had shorter interpuff intervals compared to participants in the NNC condition (ps < .05). There were no differences between research cigarette conditions at week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost. CONCLUSIONS Findings are consistent with acute VLNC cigarette topography studies and indicate that a Nicotine-reduction policy is unlikely to lead to compensation among smokers with SMI. IMPLICATIONS Given the high smoking rates among people with SMI, understanding how a Nicotine-reduction policy may affect this population is critically important. When considering the smoking topography results as a whole, smokers with SMI did not engage in compensatory smoking behavior when using VLNC cigarettes during a 6-week trial. Study findings suggest that compensatory smoking is not likely to occur among smokers with SMI if Nicotine Content is lowered to minimally addictive levels.

  • age moderates smokers subjective response to very low Nicotine Content cigarettes evidence from a randomized controlled trial
    Nicotine & Tobacco Research, 2019
    Co-Authors: Rachel N Cassidy, Joseph S Koopmeiners, Jennifer W Tidey, Dorothy K Hatsukami, Suzanne M Colby, Qing Cao, Francis J Mcclernon, Eric C Donny
    Abstract:

    Introduction Reducing the level of Nicotine in cigarettes is a regulatory strategy that has the potential to greatly improve public health. If Nicotine levels are reduced in all commercially available cigarettes, current smokers might find it easier to quit and young people might be less likely to become dependent. However, it is not yet known whether age moderates subjective or behavioral responses to low-Nicotine cigarettes. Methods Recently, a large, multisite randomized clinical trial was conducted to compare the effects of cigarettes differing in Nicotine Content (either usual-brand or research cigarettes containing 15.8, 5.2, 2.4, 1.3, or 0.4 mg Nicotine/g tobacco) across 6 weeks of exposure. In this secondary analysis, we tested whether age moderated smokers' subjective (measures of psychological reward, smoking satisfaction) and behavioral (cigarettes smoked per day, smoking topography, and Nicotine exposure) responses to cigarettes varying in Nicotine Content after 2 and 6 weeks of use, while controlling for baseline dependence and demographic factors. Results Results indicated that younger adults (age 18-24) who smoked cigarettes with 2.4-0.4 mg/g Nicotine reported significantly less smoking satisfaction and psychological reward, and smoked fewer cigarettes per day, than older adults (25+ years) after 2 weeks of use. No differences in topography were observed at either time point. After 6 weeks of use, differences had diminished on all measures. Conclusions The reduced positive effects of reduced-Nicotine Content cigarettes in young adults suggests that this regulatory policy may reduce smoking reinforcement in this vulnerable population. Implications As the FDA considers reducing the level of Nicotine in cigarettes to make them less addictive, understanding the potential impact of this policy on young people is of crucial importance. We found that young adults had significantly lower positive subjective effects to very-low Nicotine Content (VLNC) cigarettes and smoked fewer VLNC cigarettes than older adults after 2 weeks of use, indicating that this policy may reduce smoking reinforcement more quickly in young adults. These data add to the growing body of evidence on the potential for this policy to positively affect public health.

  • effect of immediate vs gradual reduction in Nicotine Content of cigarettes on biomarkers of smoke exposure a randomized clinical trial
    JAMA, 2018
    Co-Authors: Dorothy K Hatsukami, Mustafa Alabsi, Steven G Carmella, Rachel L Denlingerapte, Joni Jensen, Sharon S Allen, Paul M Cinciripini, Xianghua Luo, Menglan Chen, David J Drobes
    Abstract:

    Importance The optimal temporal approach for reducing Nicotine to minimally or nonaddictive levels in all cigarettes sold in the United States has not been determined. Objectives To determine the effects of immediate vs gradual reduction in Nicotine Content to very low levels and as compared with usual Nicotine level cigarettes on biomarkers of toxicant exposure. Design, Setting, and Participants A double-blind, randomized, parallel-design study with 2 weeks of baseline smoking and 20 weeks of intervention was conducted at 10 US sites. A volunteer sample of daily smokers with no intention to quit within 30 days was recruited between July 2014 and September 2016, with the last follow-up completed in March 2017. Interventions (1) Immediate reduction to 0.4 mg of Nicotine per gram of tobacco cigarettes; (2) gradual reduction from 15.5 mg to 0.4 mg of Nicotine per gram of tobacco cigarettes with 5 monthly dose changes; or (3) maintenance on 15.5 mg of Nicotine per gram of tobacco cigarettes. Main Outcomes and Measures Between-group differences in 3 co-primary biomarkers of smoke toxicant exposure: breath carbon monoxide (CO), urine 3-hydroxypropylmercapturic acid (3-HPMA, metabolite of acrolein), and urine phenanthrene tetraol (PheT, indicator of polycyclic aromatic hydrocarbons) calculated as area under the concentration-time curve over the 20 weeks of intervention. Results Among 1250 randomized participants (mean age, 45 years; 549 women [44%]; 958 [77%] completed the trial), significantly lower levels of exposure were observed in the immediate vs gradual reduction group for CO (mean difference, −4.06 parts per million [ppm] [95% CI, −4.89 to −3.23];P  Conclusions and Relevance Among smokers, immediate reduction of Nicotine in cigarettes led to significantly greater decreases in biomarkers of smoke exposure across time compared with gradual reduction or a control group, with no significant differences between gradual reduction and control. Trial Registration clinicaltrials.gov Identifier:NCT02139930

  • adolescent smokers response to reducing the Nicotine Content of cigarettes acute effects on withdrawal symptoms and subjective evaluations
    Drug and Alcohol Dependence, 2018
    Co-Authors: Rachel N Cassidy, Jennifer W Tidey, Suzanne M Colby, Kristina M Jackson, Patricia A Cioe, Suchitra Krishnansarin, Dorothy K Hatsukami
    Abstract:

    Abstract Background Mandating a reduction in the Nicotine Content of cigarettes to a minimally addictive level could dramatically reduce smoking rates in the US. However, little is known about the effects of reduced Nicotine Content cigarettes in adolescents. Methods Following overnight abstinence, adolescent daily smokers (ages 15–19, n = 50) reported on their craving, withdrawal, and positive and negative affect pre- and post- ad lib smoking of one cigarette containing varying Nicotine Content (15.8, 5.2, 1.3 and 0.4 mg/g of tobacco) in the laboratory and reported their subjective evaluations of each cigarette. Carbon monoxide (CO) boost from pre- to post-cigarette was calculated to determine if lower-Nicotine cigarettes led to differential acute changes in toxicant exposure. Results All four Nicotine cigarette types significantly reduced abstinence-induced craving, withdrawal, and negative affect (all p’s  Conclusions These results suggest that lower Nicotine cigarettes might result in reduced abuse liability compared to higher Nicotine Content cigarettes due to reduced positive subjective effects, while still reducing withdrawal, in adolescents. These results highlight the potential feasibility of this policy approach and support continued research on how a Nicotine reduction policy may affect adolescent smoking patterns.

Rachel L Denlingerapte - One of the best experts on this subject based on the ideXlab platform.

  • support for a Nicotine reduction policy among participants enrolled in a 20 week trial of very low Nicotine Content cigarettes
    Addictive Behaviors, 2021
    Co-Authors: Rachel L Denlingerapte, Joseph S Koopmeiners, Jennifer W Tidey, Lauren R Pacek, Tracy T Smith, Joni Jensen, Joseph F Mcclernon, Xianghua Luo, Suzanne M Colby, Herbert H Severson
    Abstract:

    Abstract Introduction The Food and Drug Administration is considering a policy to drastically reduce the allowable Nicotine Content of cigarettes. The current study examined whether the policy implementation approach, i.e., either immediately reducing Nicotine Content to very low levels or gradually reducing Nicotine Content over an extended period, influences policy support among people who smoke cigarettes. Methods Adults who smoked daily were randomly assigned (double-blind) to an immediate Nicotine reduction condition (0.4 mg/g Nicotine cigarettes), a gradual Nicotine reduction condition (15.5 to 0.4 mg/g), or a control condition (15.5 mg/g) for 20 weeks. Participants were asked if they would “support or oppose a law that reduced the amount of Nicotine in cigarettes, to make cigarettes less addictive.” Logistic regression analyses assessed if policy support was affected by treatment condition, demographic covariates, interest in quitting, and subjective cigarette effects. Results At Week 20 (N = 957 completers), 60.4% of participants supported the policy, 17.4% opposed, and 22.2% responded “Don’t know.” Policy support did not differ by treatment condition. Support was greater among those interested in quitting (OR = 3.37, 95% CI = 2.49, 4.55). Support was lower among males (OR = 0.49, 95% CI = 0.37, 0.67), those with greater dependence scores (OR = 0.92, 95% CI = 0.86, 0.99) and participants aged 18–24 (OR = 0.53, 95% CI = 0.28, 0.99). No other covariates were associated with policy support. Conclusions The majority of participants supported a Nicotine reduction policy. The implementation approach, immediate or gradual reduction, did not affect policy support. Participants interested in quitting smoking were more likely to support a Nicotine reduction policy.

  • i actually finally feel like the cigarettes aren t controlling me interviews with participants smoking very low Nicotine Content cigarettes during a residential study
    Drug and Alcohol Dependence, 2021
    Co-Authors: Rachel L Denlingerapte, Neal L. Benowitz, Dorothy K Hatsukami, Eric C Donny, Cassidy M White, Matthew J Carpenter, Tracy T Smith
    Abstract:

    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.

  • very low Nicotine Content cigarettes disrupt the feedback loop of affective states and smoking behavior
    Nicotine & Tobacco Research, 2020
    Co-Authors: Jason D Robinson, Mustafa Alabsi, Lauren R Pacek, Rachel L Denlingerapte, Joseph F Mcclernon, David J Drobes, George Kypriotakis, Scott J Leischow, Herbert H Severson, Tracy T Smith
    Abstract:

    Introduction Smoking 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 methods Participants (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. Results We 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. Conclusions Our 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. Implications These 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.

  • smoking topography characteristics during a 6 week trial of very low Nicotine Content cigarettes in smokers with serious mental illness
    Nicotine & Tobacco Research, 2020
    Co-Authors: Rachel L Denlingerapte, Dorothy K Hatsukami, Eric C Donny, Suzanne M Colby, Patricia A Cioe, Christine Goodwin, Bruce R Lindgren, Nathan Rubin, Teresa Deatley, Jennifer W Tidey
    Abstract:

    INTRODUCTION A Nicotine-reduction policy could have major benefits for smokers with serious mental illness (SMI). However, potential unintended consequences, such as compensatory smoking, should be considered to ensure that such a policy does not negatively affect this population. The purpose of this secondary analysis was to examine the impact of smoking very low Nicotine Content (VLNC) cigarettes for 6 weeks on smoking topography characteristics, indicators of compensatory smoking, among smokers with SMI. AIMS AND METHODS After a baseline usual brand smoking phase, smokers with SMI (N = 58) were randomly assigned under double-blind conditions to receive either VLNC (0.4 mg Nicotine per g tobacco) or normal Nicotine Content (NNC; 15.8 mg Nicotine per g tobacco) research cigarettes for 6 weeks. During two study visits scheduled 6 weeks apart, participants smoked either their usual brand (baseline) or assigned study cigarettes (postrandomization) through a handheld smoking topography device. Univariate analysis of variance compared smoking topography indices with cigarette condition (VLNC vs. NNC) as the between-subjects factor with corresponding baseline topography results included as covariates. RESULTS At week 6, participants in the VLNC condition smoked fewer puffs per cigarette and had shorter interpuff intervals compared to participants in the NNC condition (ps < .05). There were no differences between research cigarette conditions at week 6 for cigarette volume, puff volume, puff duration, peak flow rate, or carbon monoxide boost. CONCLUSIONS Findings are consistent with acute VLNC cigarette topography studies and indicate that a Nicotine-reduction policy is unlikely to lead to compensation among smokers with SMI. IMPLICATIONS Given the high smoking rates among people with SMI, understanding how a Nicotine-reduction policy may affect this population is critically important. When considering the smoking topography results as a whole, smokers with SMI did not engage in compensatory smoking behavior when using VLNC cigarettes during a 6-week trial. Study findings suggest that compensatory smoking is not likely to occur among smokers with SMI if Nicotine Content is lowered to minimally addictive levels.

  • effects of very low Nicotine Content cigarettes on smoking behavior and biomarkers of exposure in menthol and non menthol smokers
    Nicotine & Tobacco Research, 2019
    Co-Authors: Rachel L Denlingerapte, Michael Kotlyar, Joseph S Koopmeiners, Jennifer W Tidey, Joshua O Ikuemonisan, Lauren R Pacek, Joni Jensen, Neal L. Benowitz, Tracy T Smith
    Abstract:

    Author(s): Denlinger-Apte, Rachel L; Kotlyar, Michael; Koopmeiners, Joseph S; Tidey, Jennifer W; Luo, Xianghua; Benowitz, Neal L; Jensen, Joni A; Ikuemonisan, Joshua O; Pacek, Lauren R; Smith, Tracy T; Vandrey, Ryan; Donny, Eric C; Hatsukami, Dorothy K | Abstract: INTRODUCTION:Because 30% of cigarettes sold in the United States are characterized as menthol cigarettes, it is important to understand how menthol preference may affect the impact of a Nicotine reduction policy. METHODS:In a recent trial, non-treatment-seeking smokers were randomly assigned to receive very low Nicotine cigarettes (VLNC; 0.4 mg Nicotine/g tobacco) or normal Nicotine cigarettes (NNC; 15.5 mg/g) for 20 weeks. On the basis of preference, participants received menthol or non-menthol cigarettes. We conducted multivariable regression analyses to examine whether menthol preference moderated the effects of Nicotine Content on cigarettes per day (CPD), breath carbon monoxide (CO), urinary total Nicotine equivalents (TNE), urinary 2-cyanoethylmercapturic acid (CEMA), and abstinence. RESULTS:At baseline, menthol smokers (n = 346) reported smoking fewer CPD (14.9 vs. 19.2) and had lower TNE (52.8 vs. 71.6 nmol/mg) and CO (17.7 vs. 20.5 ppm) levels than non-menthol smokers (n = 406; ps l .05). At week 20, significant interactions indicated that menthol smokers had smaller treatment effects than non-menthol smokers for CPD (-6.4 vs. -9.3), TNE (ratio of geometric means, 0.22 vs. 0.10) and CEMA (ratio, 0.56 vs. 0.37; ps l .05), and trended toward a smaller treatment effect for CO (-4.5 vs. -7.3 ppm; p = .06). Odds ratios for abstinence at week 20 were 1.88 (95% confidence interval [CI] = 0.8 to 4.4) for menthol and 9.11 (95% CI = 3.3 to 25.2) for non-menthol VLNC smokers (p = .02) relative to the NNC condition. CONCLUSIONS:Although menthol smokers experienced reductions in smoking, toxicant exposure, and increases in quitting when using VLNC cigarettes, the magnitude of change was smaller than that observed for non-menthol smokers. IMPLICATIONS:Results of this analysis suggest that smokers of menthol cigarettes may respond to a Nicotine reduction policy with smaller reductions in smoking rates and toxicant exposure than would smokers of non-menthol cigarettes.