Changes in Cigarette Consumption With Reduced Nicotine Content Cigarettes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage: 3 Randomized Clinical Trials.
Changes in Cigarette Consumption With Reduced Nicotine Content Cigarettes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage: 3 Randomized Clinical Trials.
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DOI：
10.1001/jamanetworkopen.2020.19311
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发表时间：
2020-10-01
影响因子：
13.8
通讯作者：
Harfmann RF
中科院分区：
文献类型：
--
作者：
Higgins ST;Tidey JW;Sigmon SC;Heil SH;Gaalema DE;Lee D;Hughes JR;Villanti AC;Bunn JY;Davis DR;Bergeria CL;Streck JM;Parker MA;Miller ME;DeSarno M;Priest JS;Cioe P;MacLeod D;Barrows A;Markesich C;Harfmann RF
降低香烟的尼古丁含量是否会降低患有精神疾病或社会经济劣势的成年人的吸烟率和尼古丁依赖严重程度？这 3 项随机临床试验包括 775 名患有情感障碍、阿片类药物使用障碍或社会经济劣势的参与者，发现减少尼古丁含量可显着降低每日吸烟总量和尼古丁依赖严重程度。这些结果进一步表明，将卷烟中的尼古丁含量降低到较低水平有可能使烟草使用、成瘾以及吸烟引起的发病率和死亡率高风险人群受益。这 3 项随机临床试验研究了尼古丁含量极低的香烟在降低患有情感障碍、阿片类药物使用障碍或社会经济劣势的吸烟者吸烟率方面的功效。这项研究是一项计划工作的一部分，旨在评估将香烟中的尼古丁含量降低到最低成瘾水平的效果。研究极低尼古丁含量 (VLNC) 卷烟是否会降低患有精神疾病或社会经济劣势的吸烟者的吸烟率和依赖性严重程度。这 3 项随机临床试验于 2016 年 10 月至 2019 年 9 月在佛蒙特大学、布朗大学和约翰·霍普金斯大学进行。参与者接受为期 12 周的研究香烟暴露，尼古丁含量范围从商业香烟的代表水平（15.8 毫克尼古丁/克烟草）到低于假设的成瘾阈值（2.4 毫克/克和 0.4 毫克/克）。来自 3 个高危人群的日常吸烟者参与了研究：患有情感障碍的人，例如患有精神疾病的吸烟者；患有阿片类药物使用障碍的个体，例如患有物质使用障碍的吸烟者；以及受过高中或以下教育的女性，是处于社会经济劣势的吸烟者的例证。数据分析时间为 2019 年 9 月至 2020 年 7 月。每周免费随机分配 3 支研究香烟中的 1 支，持续 12 周。主要结果是第 12 周期间每日平均吸烟总量 (CPD) 的组间差异；次要结局包括研究和非研究香烟的 CPD 以及使用协方差分析、随机系数增长模型或重复测量方差分析分析的数周依赖性严重程度。共有 775 名参与者（平均 [SD] 年龄，35.59 [11.05] 岁；551 名 [71.10%] 女性[由于 1 人全部为女性]）；参与者在研究期间的平均吸烟量 (SD) 为 17.79 (9.18) CPD。共有 286 名参与者被随机分配至 0.4 mg/g，235 名参与者被随机分配至 2.4 mg/g，254 名参与者被随机分配至 15.8 mg/g。随机接受 VLNC 香烟的参与者在第 12 周期间各人群的平均 [SEM] 总 CPD 均有所下降（Cohen d = 0.61；P < .001）。第12周时，0.4 mg/g组的平均（SEM）CPD下降至17.96（0.98）CPD，2.4 mg/g组下降至19.53（1.07）CPD，两者均与15.8 mg/g组（第12周时为25.08 [1.08] CPD）有显着差异，但彼此没有差异（0.4 mg/g调整后的平均差异： -7.54 [95% CI，-9.51 至 -5.57]；2.4 mg/g 调整后平均差：-5.34 [95% CI，7.41 至 -3.26]）。随机分配至 VLNC 的人群中的几个次要结局存在差异，包括数周内的平均总 CPD，接受 0.4 mg/g（-0.28 [95%CI，-0.39 至 -0.18]；P < .001）和 2.4 mg/g（-0.13 [95%CI，-0.25 至 -0.01]；P < .001）的受试者的线性趋势较低； P < .001) 剂量与接受 15.8 mg/g 剂量的患者相比 (0.30 [95% CI, 0.19 至 0.41])。接受 VLNC 的参与者的尼古丁依赖性 Fagerström 测试平均总分显着较低 (Cohen d = 0.12；P < .001)，而接受 0.4 mg/g 剂量的参与者则显着较低 (平均 [SD] 分数，3.99 [0.06]；P < .001 vs 15.8 mg/g) 或 2.4 mg/g 剂量（平均 [SD] 评分，4.07 [0.06]；P = .01 vs 15.8 mg/g）与接受 15.8 mg/g 剂量的患者（平均 [SD] 评分，4.31 [0.06]）不同，但彼此没有差异。这些发现表明，将香烟的尼古丁含量降低到非常低的水平可以降低这些高危人群的吸烟率和尼古丁依赖的严重程度，这些影响可能有助于成功戒烟。 ClinicalTrials.gov 标识符：NCT02232737、NCT02250664、NCT02250534
Does reducing the nicotine content of cigarettes decrease smoking rates and nicotine dependence severity among adults with psychiatric disorders or socioeconomic disadvantage? These 3 randomized clinical trials including 775 participants with affective disorders, opioid use disorder, or socioeconomic disadvantage found that reducing nicotine content significantly decreased total cigarettes smoked daily and nicotine dependence severity. These results further demonstrate that reducing nicotine content of cigarettes to low levels has potential to benefit populations at high risk for tobacco use, addiction, and smoking-attributable morbidity and mortality. These 3 randomized clinical trials examine the efficacy of very low-nicotine-content cigarettes in reducing smoking rates among smokers with affective disorders, opioid use disorders, or socioeconomic disadvantage. This study is part of a programmatic effort evaluating the effects of reducing nicotine content of cigarettes to minimally addictive levels. To examine whether very low-nicotine-content (VLNC) cigarettes decrease smoking rates and dependence severity among smokers with psychiatric disorders or socioeconomic disadvantage. 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. Random assignment to 1 of 3 study cigarettes provided weekly at no cost for 12 weeks. 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. 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]). Fagerström 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. 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. ClinicalTrials.gov Identifiers: NCT02232737, NCT02250664, NCT02250534
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DOI：
10.1158/1055-9965.epi-12-1439
发表时间：
2013-06
期刊：
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology
影响因子：
--
作者：
Hatsukami DK;Hertsgaard LA;Vogel RI;Jensen JA;Murphy SE;Hecht SS;Carmella SG;al'Absi M;Joseph AM;Allen SS
通讯作者：
Allen SS
DOI：
10.1158/1055-9965.epi-11-0644
发表时间：
2012-05
期刊：
Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology
影响因子：
--
作者：
Benowitz NL;Dains KM;Hall SM;Stewart S;Wilson M;Dempsey D;Jacob P 3rd
通讯作者：
Jacob P 3rd
影响因子：
--
作者：
Hser, YI;Hoffman, V;Anglin, MD
通讯作者：
Anglin, MD
影响因子：
6
作者：
Hatsukami, Dorothy K.;Kotlyar, Michael;Hecht, Stephen S.
通讯作者：
Hecht, Stephen S.
影响因子：
25.8
作者：
Higgins, Stephen T.;Heil, Sarah H.;Tursi, Lauren
通讯作者：
Tursi, Lauren