TY - JOUR
T1 - Cumulative vulnerabilities as a potential moderator of response to reduced nicotine content cigarettes
AU - Higgins, Stephen T.
AU - DeSarno, Michael
AU - Bunn, Janice Y.
AU - Gaalema, Diann E.
AU - Leventhal, Adam M.
AU - Davis, Danielle R.
AU - Streck, Joanna M.
AU - Harfmann, Roxanne F.
AU - Markesich, Catherine
AU - Orr, Eva
AU - Sigmon, Stacey C.
AU - Heil, Sarah H.
AU - Tidey, Jennifer W.
AU - Lee, Dustin
AU - Hughes, John R.
N1 - Funding Information:
This project was supported by Tobacco Centers of Regulatory Science (TCORS) awards U54DA036114 from the National Institute on Drug Abuse and Food and Drug Administration (FDA) and U54CA180908 from the National Cancer Institute and FDA. Preparation of the report was also supported in part by a Centers of Biomedical Research Excellence award P20GM103644 from the National Institute on General Medical Sciences. The content of this report is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or Food and Drug Administration. Funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Funding Information:
This project was supported by Tobacco Centers of Regulatory Science (TCORS) awards U54DA036114 from the National Institute on Drug Abuse and Food and Drug Administration (FDA) and U54CA180908 from the National Cancer Institute and FDA. Preparation of the report was also supported in part by a Centers of Biomedical Research Excellence award P20GM103644 from the National Institute on General Medical Sciences and Health Resources and Services Administration (HRSA) center (grant number UD9RH33633 ) from the U.S. Department of Health and Human Services . The content of this report is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, Food and Drug Administration or Health Resources and Services Administration . Funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
Publisher Copyright:
© 2021
PY - 2021/11
Y1 - 2021/11
N2 - Risk for smoking increases in a summative manner corresponding to the number of co-occurring vulnerabilities present (cumulative vulnerability). We examined whether cumulative vulnerabilities moderate response to reduced nicotine content cigarettes in a secondary analysis of results from 775 participants in three 12-week randomized clinical trials examining research cigarettes varying in nicotine content (0.4, 2.4, 15.8 mg nicotine/g tobacco). Participants were categorized as having 0–1, 2–3, or ≥ 4 cumulative vulnerabilities. Vulnerabilities included: rural residence, current substance use disorder, current affective disorder, low educational attainment, poverty, unemployment, physical disability. The primary outcome was total cigarettes per day (CPD) during Week 12; secondary outcomes included CPD across weeks, toxin exposure, dependence severity, craving/withdrawal (17 dependent measures). Results were analyzed using repeated measures analysis of covariance and growth-curve modeling. Total CPD during Week 12 increased as cumulative-vulnerability increased (P = 0.004), and decreased as nicotine content decreased (P < 0.001), with no significant interaction of cumulative vulnerability and dose (P = 0.67). Effects on other outcomes generally followed that same pattern. The only exception across the other outcomes was on Questionnaire-on-Smoking-Urges Factor-2 ratings for usual-brand cigarettes where cumulative vulnerability, dose, and time interacted (P = 0.007), with craving at the 0.4 and 2.4 mg/g doses decreasing over time, but inconsistently across vulnerability categories. Overall, we saw little evidence that cumulative vulnerabilities moderate response to reduced nicotine content cigarettes suggesting that a policy reducing nicotine content in cigarettes to minimally addictive levels could benefit even highly vulnerable smokers including those residing in rural or other regions with overrepresentation of co-occurring vulnerabilities. Clinicaltrials.gov identifiers: NCT02232737, NCT02250664, NCT02250534.
AB - Risk for smoking increases in a summative manner corresponding to the number of co-occurring vulnerabilities present (cumulative vulnerability). We examined whether cumulative vulnerabilities moderate response to reduced nicotine content cigarettes in a secondary analysis of results from 775 participants in three 12-week randomized clinical trials examining research cigarettes varying in nicotine content (0.4, 2.4, 15.8 mg nicotine/g tobacco). Participants were categorized as having 0–1, 2–3, or ≥ 4 cumulative vulnerabilities. Vulnerabilities included: rural residence, current substance use disorder, current affective disorder, low educational attainment, poverty, unemployment, physical disability. The primary outcome was total cigarettes per day (CPD) during Week 12; secondary outcomes included CPD across weeks, toxin exposure, dependence severity, craving/withdrawal (17 dependent measures). Results were analyzed using repeated measures analysis of covariance and growth-curve modeling. Total CPD during Week 12 increased as cumulative-vulnerability increased (P = 0.004), and decreased as nicotine content decreased (P < 0.001), with no significant interaction of cumulative vulnerability and dose (P = 0.67). Effects on other outcomes generally followed that same pattern. The only exception across the other outcomes was on Questionnaire-on-Smoking-Urges Factor-2 ratings for usual-brand cigarettes where cumulative vulnerability, dose, and time interacted (P = 0.007), with craving at the 0.4 and 2.4 mg/g doses decreasing over time, but inconsistently across vulnerability categories. Overall, we saw little evidence that cumulative vulnerabilities moderate response to reduced nicotine content cigarettes suggesting that a policy reducing nicotine content in cigarettes to minimally addictive levels could benefit even highly vulnerable smokers including those residing in rural or other regions with overrepresentation of co-occurring vulnerabilities. Clinicaltrials.gov identifiers: NCT02232737, NCT02250664, NCT02250534.
KW - Cigarette smoking
KW - Cumulative vulnerability
KW - Nicotine dependence
KW - Reduced nicotine content cigarettes
KW - Toxin exposure
KW - Vulnerable populations
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U2 - 10.1016/j.ypmed.2021.106714
DO - 10.1016/j.ypmed.2021.106714
M3 - Article
C2 - 34242666
AN - SCOPUS:85110389996
VL - 152
JO - Preventive Medicine
JF - Preventive Medicine
SN - 0091-7435
M1 - 106714
ER -