Smoking abstinence and cessation-related outcomes one month after an immediate versus gradual reduction in nicotine content of cigarettes

Elias M. Klemperer; Xianghua Luo; Joni Jensen; Mustafa al'Absi; Paul M. Cinciripini; Jason D. Robinson; David J. Drobes; Joseph McClernon; Andrew A. Strasser; Lori S Strayer; Ryan Vandrey; Neal L. Benowitz; Eric C. Donny; Dorothy K. Hatsukami

doi:10.1016/j.ypmed.2022.107175

Smoking abstinence and cessation-related outcomes one month after an immediate versus gradual reduction in nicotine content of cigarettes

Elias M. Klemperer, Xianghua Luo, Joni Jensen, Mustafa al'Absi, Paul M. Cinciripini, Jason D. Robinson, David J. Drobes, Joseph McClernon, Andrew A. Strasser, Lori S Strayer, Ryan Vandrey, Neal L. Benowitz, Eric C. Donny, Dorothy K. Hatsukami

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

Abstract

The United States Food and Drug Administration has the authority to reduce the nicotine content in cigarettes to minimal or non-addictive levels and could do so immediately or gradually over time. A large clinical trial compared the two approaches. This secondary analysis assesses abstinence and cessation-related outcomes one month after the trial concluded, when participants no longer had access to very low nicotine content (VLNC) research cigarettes. Smokers not interested in quitting (N = 1250) were recruited for the parent trial from 2014 to 2016 across 10 sites throughout the US and randomized to a 20-week study period during which they immediately switched to VLNC cigarettes, gradually transitioned to VLNC cigarettes with five monthly dose reductions, or smoked normal nicotine research cigarettes (control). At the one-month follow-up, both immediate and gradual reduction resulted in greater mean cigarette-free days (4.7 and 4.6 respectively) than the control group (3.2, both p < .05). Immediate reduction resulted in fewer mean cigarettes per day (CPD = 10.3) and lower Fagerström Test for Cigarette Dependence (FTCD = 3.7) than the gradual (CPD = 11.7, p = .001; FTCD = 3.8, p = .039) and control (CPD = 13.5, p < .001; FTCD = 4.0, p < .001) groups. Compared to controls, gradual reduction resulted in reduced CPD (p = .012) but not FTCD (p = .13). Differences in CO-verified 7-day point-prevalence abstinence were not significant. Findings demonstrate that switching to VLNC cigarettes resulted in reduced smoking and nicotine dependence severity that was sustained for at least a month after the VLNC trial period in smokers who were not interested in cessation. The greatest harm reduction endpoints were observed in those who immediately transitioned to VLNC cigarettes.

Original language	English (US)
Article number	107175
Journal	Preventive medicine
Volume	165
Issue number	Pt B
DOIs	https://doi.org/10.1016/j.ypmed.2022.107175
State	Published - Dec 2022

Bibliographical note

Funding Information:
The authors were supported by grant numbers U54DA031659 (DKH, XL) and U54DA036114 (EMK) from the National Institute on Drug Abuse and the Food and Drug Administration as well as P20GM103644 from National Institute of General Medical Sciences (EMK) and P30CA07759 from National Cancer Institute (XL).

Funding Information:
EMK, XL, JJ, MA PMC, JDR, LGS, ECD, and DKH have nothing to disclose. DJD has served as a paid expert witness in litigation against tobacco companies. JM has provided consulting and marketing research services to GlaxoSmithKline Consumer Healthcare on smoking cessation behavioral support programs. AAS has received grant support through the Pfizer GRAND grant funding program. RV has received compensation for consulting or scientific advisory board service to Canopy Health Innovations Inc., MyMD Pharmaceuticals, Mira Therapeutics Inc., Syqe Medical Ltd., Radicle Science LLC, and WebMD. NLB serves as a consultant to Pfizer and Achieve Life Sciences, companies that market or are developing smoking cessation medications, and has been a paid expert witness in litigation against tobacco companies.

Publisher Copyright:
© 2022 Elsevier Inc.

Keywords

Cigarette smoking
Harm reduction
Nicotine reduction
Smoking cessation
Tobacco regulatory science
Very low nicotine content cigarettes
Nicotine/adverse effects
United States
Humans
Tobacco Use Disorder
Tobacco Products
Smoking Cessation/methods
Smoking

PubMed: MeSH publication types

Randomized Controlled Trial
Journal Article
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, P.H.S.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.ypmed.2022.107175

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Klemperer, E. M., Luo, X., Jensen, J., al'Absi, M., Cinciripini, P. M., Robinson, J. D., Drobes, D. J., McClernon, J., Strasser, A. A., Strayer, L. S., Vandrey, R., Benowitz, N. L., Donny, E. C., & Hatsukami, D. K. (2022). Smoking abstinence and cessation-related outcomes one month after an immediate versus gradual reduction in nicotine content of cigarettes. Preventive medicine, 165(Pt B), Article 107175. https://doi.org/10.1016/j.ypmed.2022.107175

Klemperer, EM, Luo, X, Jensen, J, al'Absi, M, Cinciripini, PM, Robinson, JD, Drobes, DJ, McClernon, J, Strasser, AA, Strayer, LS, Vandrey, R, Benowitz, NL, Donny, EC & Hatsukami, DK 2022, 'Smoking abstinence and cessation-related outcomes one month after an immediate versus gradual reduction in nicotine content of cigarettes', Preventive medicine, vol. 165, no. Pt B, 107175. https://doi.org/10.1016/j.ypmed.2022.107175

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abstract = "The United States Food and Drug Administration has the authority to reduce the nicotine content in cigarettes to minimal or non-addictive levels and could do so immediately or gradually over time. A large clinical trial compared the two approaches. This secondary analysis assesses abstinence and cessation-related outcomes one month after the trial concluded, when participants no longer had access to very low nicotine content (VLNC) research cigarettes. Smokers not interested in quitting (N = 1250) were recruited for the parent trial from 2014 to 2016 across 10 sites throughout the US and randomized to a 20-week study period during which they immediately switched to VLNC cigarettes, gradually transitioned to VLNC cigarettes with five monthly dose reductions, or smoked normal nicotine research cigarettes (control). At the one-month follow-up, both immediate and gradual reduction resulted in greater mean cigarette-free days (4.7 and 4.6 respectively) than the control group (3.2, both p < .05). Immediate reduction resulted in fewer mean cigarettes per day (CPD = 10.3) and lower Fagerstr{\"o}m Test for Cigarette Dependence (FTCD = 3.7) than the gradual (CPD = 11.7, p = .001; FTCD = 3.8, p = .039) and control (CPD = 13.5, p < .001; FTCD = 4.0, p < .001) groups. Compared to controls, gradual reduction resulted in reduced CPD (p = .012) but not FTCD (p = .13). Differences in CO-verified 7-day point-prevalence abstinence were not significant. Findings demonstrate that switching to VLNC cigarettes resulted in reduced smoking and nicotine dependence severity that was sustained for at least a month after the VLNC trial period in smokers who were not interested in cessation. The greatest harm reduction endpoints were observed in those who immediately transitioned to VLNC cigarettes.",

keywords = "Cigarette smoking, Harm reduction, Nicotine reduction, Smoking cessation, Tobacco regulatory science, Very low nicotine content cigarettes, Nicotine/adverse effects, United States, Humans, Tobacco Use Disorder, Tobacco Products, Smoking Cessation/methods, Smoking",

author = "Klemperer, {Elias M.} and Xianghua Luo and Joni Jensen and Mustafa al'Absi and Cinciripini, {Paul M.} and Robinson, {Jason D.} and Drobes, {David J.} and Joseph McClernon and Strasser, {Andrew A.} and Strayer, {Lori S} and Ryan Vandrey and Benowitz, {Neal L.} and Donny, {Eric C.} and Hatsukami, {Dorothy K.}",

note = "Funding Information: The authors were supported by grant numbers U54DA031659 (DKH, XL) and U54DA036114 (EMK) from the National Institute on Drug Abuse and the Food and Drug Administration as well as P20GM103644 from National Institute of General Medical Sciences (EMK) and P30CA07759 from National Cancer Institute (XL). Funding Information: EMK, XL, JJ, MA PMC, JDR, LGS, ECD, and DKH have nothing to disclose. DJD has served as a paid expert witness in litigation against tobacco companies. JM has provided consulting and marketing research services to GlaxoSmithKline Consumer Healthcare on smoking cessation behavioral support programs. AAS has received grant support through the Pfizer GRAND grant funding program. RV has received compensation for consulting or scientific advisory board service to Canopy Health Innovations Inc., MyMD Pharmaceuticals, Mira Therapeutics Inc., Syqe Medical Ltd., Radicle Science LLC, and WebMD. NLB serves as a consultant to Pfizer and Achieve Life Sciences, companies that market or are developing smoking cessation medications, and has been a paid expert witness in litigation against tobacco companies. Publisher Copyright: {\textcopyright} 2022 Elsevier Inc.",

year = "2022",

month = dec,

doi = "10.1016/j.ypmed.2022.107175",

language = "English (US)",

volume = "165",

journal = "Preventive medicine",

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T1 - Smoking abstinence and cessation-related outcomes one month after an immediate versus gradual reduction in nicotine content of cigarettes

AU - Klemperer, Elias M.

AU - Luo, Xianghua

AU - Jensen, Joni

AU - al'Absi, Mustafa

AU - Cinciripini, Paul M.

AU - Robinson, Jason D.

AU - Drobes, David J.

AU - McClernon, Joseph

AU - Strasser, Andrew A.

AU - Strayer, Lori S

AU - Vandrey, Ryan

AU - Benowitz, Neal L.

AU - Donny, Eric C.

AU - Hatsukami, Dorothy K.

N1 - Funding Information: The authors were supported by grant numbers U54DA031659 (DKH, XL) and U54DA036114 (EMK) from the National Institute on Drug Abuse and the Food and Drug Administration as well as P20GM103644 from National Institute of General Medical Sciences (EMK) and P30CA07759 from National Cancer Institute (XL). Funding Information: EMK, XL, JJ, MA PMC, JDR, LGS, ECD, and DKH have nothing to disclose. DJD has served as a paid expert witness in litigation against tobacco companies. JM has provided consulting and marketing research services to GlaxoSmithKline Consumer Healthcare on smoking cessation behavioral support programs. AAS has received grant support through the Pfizer GRAND grant funding program. RV has received compensation for consulting or scientific advisory board service to Canopy Health Innovations Inc., MyMD Pharmaceuticals, Mira Therapeutics Inc., Syqe Medical Ltd., Radicle Science LLC, and WebMD. NLB serves as a consultant to Pfizer and Achieve Life Sciences, companies that market or are developing smoking cessation medications, and has been a paid expert witness in litigation against tobacco companies. Publisher Copyright: © 2022 Elsevier Inc.

PY - 2022/12

Y1 - 2022/12

N2 - The United States Food and Drug Administration has the authority to reduce the nicotine content in cigarettes to minimal or non-addictive levels and could do so immediately or gradually over time. A large clinical trial compared the two approaches. This secondary analysis assesses abstinence and cessation-related outcomes one month after the trial concluded, when participants no longer had access to very low nicotine content (VLNC) research cigarettes. Smokers not interested in quitting (N = 1250) were recruited for the parent trial from 2014 to 2016 across 10 sites throughout the US and randomized to a 20-week study period during which they immediately switched to VLNC cigarettes, gradually transitioned to VLNC cigarettes with five monthly dose reductions, or smoked normal nicotine research cigarettes (control). At the one-month follow-up, both immediate and gradual reduction resulted in greater mean cigarette-free days (4.7 and 4.6 respectively) than the control group (3.2, both p < .05). Immediate reduction resulted in fewer mean cigarettes per day (CPD = 10.3) and lower Fagerström Test for Cigarette Dependence (FTCD = 3.7) than the gradual (CPD = 11.7, p = .001; FTCD = 3.8, p = .039) and control (CPD = 13.5, p < .001; FTCD = 4.0, p < .001) groups. Compared to controls, gradual reduction resulted in reduced CPD (p = .012) but not FTCD (p = .13). Differences in CO-verified 7-day point-prevalence abstinence were not significant. Findings demonstrate that switching to VLNC cigarettes resulted in reduced smoking and nicotine dependence severity that was sustained for at least a month after the VLNC trial period in smokers who were not interested in cessation. The greatest harm reduction endpoints were observed in those who immediately transitioned to VLNC cigarettes.

AB - The United States Food and Drug Administration has the authority to reduce the nicotine content in cigarettes to minimal or non-addictive levels and could do so immediately or gradually over time. A large clinical trial compared the two approaches. This secondary analysis assesses abstinence and cessation-related outcomes one month after the trial concluded, when participants no longer had access to very low nicotine content (VLNC) research cigarettes. Smokers not interested in quitting (N = 1250) were recruited for the parent trial from 2014 to 2016 across 10 sites throughout the US and randomized to a 20-week study period during which they immediately switched to VLNC cigarettes, gradually transitioned to VLNC cigarettes with five monthly dose reductions, or smoked normal nicotine research cigarettes (control). At the one-month follow-up, both immediate and gradual reduction resulted in greater mean cigarette-free days (4.7 and 4.6 respectively) than the control group (3.2, both p < .05). Immediate reduction resulted in fewer mean cigarettes per day (CPD = 10.3) and lower Fagerström Test for Cigarette Dependence (FTCD = 3.7) than the gradual (CPD = 11.7, p = .001; FTCD = 3.8, p = .039) and control (CPD = 13.5, p < .001; FTCD = 4.0, p < .001) groups. Compared to controls, gradual reduction resulted in reduced CPD (p = .012) but not FTCD (p = .13). Differences in CO-verified 7-day point-prevalence abstinence were not significant. Findings demonstrate that switching to VLNC cigarettes resulted in reduced smoking and nicotine dependence severity that was sustained for at least a month after the VLNC trial period in smokers who were not interested in cessation. The greatest harm reduction endpoints were observed in those who immediately transitioned to VLNC cigarettes.

KW - Cigarette smoking

KW - Harm reduction

KW - Nicotine reduction

KW - Smoking cessation

KW - Tobacco regulatory science

KW - Very low nicotine content cigarettes

KW - Nicotine/adverse effects

KW - United States

KW - Humans

KW - Tobacco Use Disorder

KW - Tobacco Products

KW - Smoking Cessation/methods

KW - Smoking

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VL - 165

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Smoking abstinence and cessation-related outcomes one month after an immediate versus gradual reduction in nicotine content of cigarettes

Abstract

Bibliographical note

Keywords

PubMed: MeSH publication types

UN SDGs

Publisher link

Find It

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