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- Title
Changes in Cigarette Consumption With Reduced Nicotine Content Cigarettes Among Smokers With Psychiatric Conditions or Socioeconomic Disadvantage: 3 Randomized Clinical Trials.
- Authors
Higgins, Stephen T.; Tidey, Jennifer W.; Sigmon, Stacey C.; Heil, Sarah H.; Gaalema, Diann E.; Lee, Dustin; Hughes, John R.; Villanti, Andrea C.; Bunn, Janice Y.; Davis, Danielle R.; Bergeria, Cecilia L.; Streck, Joanna M.; Parker, Maria A.; Miller, Mollie E.; DeSarno, Michael; Priest, Jeff S.; Cioe, Patricia; MacLeod, Douglas; Barrows, Anthony; Markesich, Catherine
- Abstract
Key Points: Question: Does reducing the nicotine content of cigarettes decrease smoking rates and nicotine dependence severity among adults with psychiatric disorders or socioeconomic disadvantage? Findings: 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. Meaning: 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. 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]). 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. 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
- Subjects
MARYLAND; RHODE Island; SMOKING prevention; AFFECTIVE disorders; ANALYSIS of covariance; CONFIDENCE intervals; MENTAL illness; NARCOTICS; NICOTINE; RESEARCH funding; STATISTICAL sampling; STATISTICS; SUBSTANCE abuse; LOGISTIC regression analysis; DATA analysis; SOCIOECONOMIC factors; HARM reduction; TOBACCO products; RANDOMIZED controlled trials; DATA analysis software; DESCRIPTIVE statistics
- Publication
JAMA Network Open, 2020, Vol 3, Issue 10, pe2019311
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2020.19311