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''' <big><span style="background-color: rgb(255, 255, 0);" data-mce-style="background-color: #ffff00;">[https://pubmed.ncbi.nlm.nih.gov/35302289/ Abuse Liability]</span>: The potential to develop a dependence or addiction to a substance.</big>''' | ''' <big><span style="background-color: rgb(255, 255, 0);" data-mce-style="background-color: #ffff00;">[https://pubmed.ncbi.nlm.nih.gov/35302289/ Abuse Liability]</span>: The potential to develop a dependence or addiction to a substance.</big>''' | ||
'''<big><span style="background-color: rgb(255, 255, 0);" data-mce-style="background-color: #ffff00;">Recommended Podcast</span>: [https://www.thestudiesshowpod.com/p/episode-40-addiction The Studies Show Episode 40: Addiction]</big>''' | |||
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='''Background Information'''= | |||
===2009 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2798587/ Abuse liability assessment of tobacco products including potential reduced exposure products]=== | |||
*" In the 2009 law giving FDA regulation over tobacco products, FDA is now required to evaluate new tobacco products including MRTP/PREPs to determine their risk for abuse and toxicity at the population level. This article describes the traditional tools and methods of ALA that can be used to evaluate new tobacco and nicotine products including MRTP/PREPs. Such ALA data could contribute to the scientific foundation on which future public policy decisions are based." | |||
**Citation: Carter LP, Stitzer ML, Henningfield JE, O'Connor RJ, Cummings KM, Hatsukami DK. Abuse liability assessment of tobacco products including potential reduced exposure products. Cancer Epidemiol Biomarkers Prev. 2009 Dec;18(12):3241-62. doi: 10.1158/1055-9965.EPI-09-0948. PMID: 19959676; PMCID: PMC2798587. | |||
***Acknowledgment: Supported by National Cancer Institute contract N01-PC-64402 - Laboratory Assessment of Tobacco Use Behavior and Exposure to Toxins Among Users of New Tobacco Products. This article is one in a series of articles on the methods and measures for the evaluation of potential reduced exposure products. Jack E. Henningfield provides consulting support to GlaxoSmithKline Consumer Healthcare through Pinney Associates on an exclusive basis regarding tobacco dependence treatment (GSK had no editorial input into this manuscript), has a financial interest in a potential new oral nicotine replacement therapy product, and serves an expert witness in litigation against the tobacco industry. Dorothy Hatsukami has received a research grant from NabiBiopharmaceuticals to conduct a trial on the nicotine vaccine. Mike Cummnings has received payments as a paid expert witness for plaintiffs in litigation against the tobacco industry and consulting and/or speaker fees from Novartis Corporation (to attend two meetings they have sponsored on the topic of smoking cessation) and Pfizer Corporation (to give talks to health professionals on the subject of smoking cessation). Maxine Stitzer has received funding from Pfizer for an investigator-initiated study. | |||
='''Smoking - Combustible Tobacco'''= | ='''Smoking - Combustible Tobacco'''= | ||
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**Citation: Browne M, Todd DG. Then and now: Consumption and dependence in e-cigarette users who formerly smoked cigarettes. Addict Behav. 2018 Jan;76:113-121. doi: 10.1016/j.addbeh.2017.07.034. Epub 2017 Jul 28. PMID: 28780356. | **Citation: Browne M, Todd DG. Then and now: Consumption and dependence in e-cigarette users who formerly smoked cigarettes. Addict Behav. 2018 Jan;76:113-121. doi: 10.1016/j.addbeh.2017.07.034. Epub 2017 Jul 28. PMID: 28780356. | ||
***Acknowledgement: Research was supported by block funding to the School of Health, Medical and Applied Sciences, Central Queensland University. No conflicts of interest to declare. | ***Acknowledgement: Research was supported by block funding to the School of Health, Medical and Applied Sciences, Central Queensland University. No conflicts of interest to declare. | ||
===2017 [https://pubmed.ncbi.nlm.nih.gov/28634710/ Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combustible cigarettes, and nicotine gum: implications for abuse liability]=== | |||
*"In summary, this study is the most robust assessment of the abuse liability of ECs published to date and uses approaches similar to those found in classic abuse liability studies of pharmaceutical products, including multiple instruments to measure the subjective effects of product use, as well as nicotine uptake. Under the set of study conditions described herein, use of the three Vuse Solo ECs tended to result in subjective measures responses and nicotine uptake that were between those measured with use of combustible cigarettes and nicotine gum. In general, the results are consistent with the conclusions of others that the abuse liability of ECs as a category is less than that of combustible cigarettes but greater than for nicotine gum, and likely other nicotine replacement products' | |||
**Citation: Stiles MF, Campbell LR, Graff DW, Jones BA, Fant RV, Henningfield JE. Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combustible cigarettes, and nicotine gum: implications for abuse liability. Psychopharmacology (Berl). 2017 Sep;234(17):2643-2655. doi: 10.1007/s00213-017-4665-y. Epub 2017 Jun 20. PMID: 28634710; PMCID: PMC5548902. | |||
***Acknowledgment: Funding; This study was funded by RJ Reynolds Vapor Company through its affiliate RJ Reynolds Tobacco Company. COI; MF Stiles, LR Campbell, and BA Jones are full-time employees of RAI Services Company, which provides support across the Reynolds American Inc. operating companies. DW Graff is a full-time employee of Celerion and provided the original draft of this manuscript. RV Fant and JE Henningfield are full-time employees of PinneyAssociates, which provides consulting services on tobacco harm minimization (including nicotine replacement therapy and digital vapor products) to Niconovum USA, RJ Reynolds Vapor Company, and RAI Services Company (all subsidiaries of Reynolds American Inc.) In the past 3 years, PinneyAssociates has consulted to GlaxoSmithKline Consumer Healthcare on smoking cessation and NJOY on electronic cigarettes. JE Henningfield also owns an interest in intellectual property for a novel nicotine medication, an option for which has been sold to Niconovum USA. Through PinneyAssociates, Fant and Henningfield also provide consulting services to pharmaceutical companies on abuse potential assessment and the regulation of substances with a potential for abuse. | |||
===2015 [https://pubmed.ncbi.nlm.nih.gov/25332459/ Development of a questionnaire for assessing dependence on electronic cigarettes among a large sample of ex-smoking E-cigarette users]=== | ===2015 [https://pubmed.ncbi.nlm.nih.gov/25332459/ Development of a questionnaire for assessing dependence on electronic cigarettes among a large sample of ex-smoking E-cigarette users]=== | ||
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**Citation: Etter JF. Explaining the effects of electronic cigarettes on craving for tobacco in recent quitters. Drug Alcohol Depend. 2015 Mar 1;148:102-8. doi: 10.1016/j.drugalcdep.2014.12.030. Epub 2015 Jan 3. PMID: 25592454. | **Citation: Etter JF. Explaining the effects of electronic cigarettes on craving for tobacco in recent quitters. Drug Alcohol Depend. 2015 Mar 1;148:102-8. doi: 10.1016/j.drugalcdep.2014.12.030. Epub 2015 Jan 3. PMID: 25592454. | ||
***Acknowledgment: This study was partly funded by the Swiss Tobacco Prevention Fund (Swiss Federal Office of Public Health), grant 12.000189 to JFE. The Swiss Tobacco Prevention Fund had no role in the design or conduct of the study, interpretation of the data or decision to submit the paper for publication... JFE was reimbursed by Dekang, a manufacturer of e-cigarettes and e-liquids for traveling to London and to China, to visit e-cigarette factories, but he received no honoraria for these meetings. JFE's salary is paid by the University of Geneva... Vincent Baujard, from the HON Foundation, Geneva, Switzerland developed the software for data collection. Thomas Eissenberg (Virginia Commonwealth University, USA), was a consultant for this study... | ***Acknowledgment: This study was partly funded by the Swiss Tobacco Prevention Fund (Swiss Federal Office of Public Health), grant 12.000189 to JFE. The Swiss Tobacco Prevention Fund had no role in the design or conduct of the study, interpretation of the data or decision to submit the paper for publication... JFE was reimbursed by Dekang, a manufacturer of e-cigarettes and e-liquids for traveling to London and to China, to visit e-cigarette factories, but he received no honoraria for these meetings. JFE's salary is paid by the University of Geneva... Vincent Baujard, from the HON Foundation, Geneva, Switzerland developed the software for data collection. Thomas Eissenberg (Virginia Commonwealth University, USA), was a consultant for this study... | ||
='''Heated Tobacco Product (HTP)'''= | |||
===2022 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9424205/ An abuse liability assessment of the glo tobacco heating product in comparison to combustible cigarettes and nicotine replacement therapy]=== | |||
*"These findings suggest that the abuse liability of the THPs lies between that of subjects usual brand cigarettes and the NRT." | |||
**Citation: Hardie G, Gale N, McEwan M, Oscar SM, Ziviani L, Proctor CJ, Murphy J. An abuse liability assessment of the glo tobacco heating product in comparison to combustible cigarettes and nicotine replacement therapy. Sci Rep. 2022 Aug 29;12(1):14701. doi: 10.1038/s41598-022-19167-8. Erratum in: Sci Rep. 2023 Jun 27;13(1):10441. doi: 10.1038/s41598-023-37432-2. PMID: 36038580; PMCID: PMC9424205. | |||
***Acknowledgment: The study was funded in full by British American Tobacco (Investments) Limited (BAT). GH, NG, and MMcE are current employees of BAT. JM was an employee of BAT at the time of the study conduct and is currently an employee of R. J. Reynolds Tobacco Company, a subsidiary of BAT. CJP was an employee of BAT at the time of study conduct and is currently contracted to BAT to provide consultancy on tobacco product science and regulation. SM and LZ are employees of CRC, the clinic who performed the trial. | |||
='''Nicotine Pouches'''= | ='''Nicotine Pouches'''= | ||
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**Citation: Campbell C, Jin T, Round EK, Schmidt E, Nelson P, Baxter S. Part one: abuse liability of Vuse Solo (G2) electronic nicotine delivery system relative to combustible cigarettes and nicotine gum. Sci Rep. 2022 Dec 21;12(1):22080. doi: 10.1038/s41598-022-26417-2. PMID: 36543869; PMCID: PMC9772348. | **Citation: Campbell C, Jin T, Round EK, Schmidt E, Nelson P, Baxter S. Part one: abuse liability of Vuse Solo (G2) electronic nicotine delivery system relative to combustible cigarettes and nicotine gum. Sci Rep. 2022 Dec 21;12(1):22080. doi: 10.1038/s41598-022-26417-2. PMID: 36543869; PMCID: PMC9772348. | ||
***Acknowledgment: C.C., T.J., E.S., E.R., and S.B. are full-time employees of RAI Services Company, and P.N. is a former full-time employee of RAI Services Company. RAI Services Company is a wholly owned subsidiary of Reynolds American Inc., which is an indirect, wholly owned subsidiary of British American Tobacco plc. | ***Acknowledgment: C.C., T.J., E.S., E.R., and S.B. are full-time employees of RAI Services Company, and P.N. is a former full-time employee of RAI Services Company. RAI Services Company is a wholly owned subsidiary of Reynolds American Inc., which is an indirect, wholly owned subsidiary of British American Tobacco plc. | ||
===2022 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9424205/ An abuse liability assessment of the glo tobacco heating product in comparison to combustible cigarettes and nicotine replacement therapy]=== | |||
*"These findings suggest that the abuse liability of the THPs lies between that of subjects usual brand cigarettes and the NRT." | |||
**Citation: Hardie G, Gale N, McEwan M, Oscar SM, Ziviani L, Proctor CJ, Murphy J. An abuse liability assessment of the glo tobacco heating product in comparison to combustible cigarettes and nicotine replacement therapy. Sci Rep. 2022 Aug 29;12(1):14701. doi: 10.1038/s41598-022-19167-8. Erratum in: Sci Rep. 2023 Jun 27;13(1):10441. doi: 10.1038/s41598-023-37432-2. PMID: 36038580; PMCID: PMC9424205. | |||
***Acknowledgment: The study was funded in full by British American Tobacco (Investments) Limited (BAT). GH, NG, and MMcE are current employees of BAT. JM was an employee of BAT at the time of the study conduct and is currently an employee of R. J. Reynolds Tobacco Company, a subsidiary of BAT. CJP was an employee of BAT at the time of study conduct and is currently contracted to BAT to provide consultancy on tobacco product science and regulation. SM and LZ are employees of CRC, the clinic who performed the trial. | |||
===2020 [https://pubmed.ncbi.nlm.nih.gov/33176942/ Abuse liability assessment of the JUUL system in four flavors relative to combustible cigarette, nicotine gum and a comparator electronic nicotine delivery system among adult smokers]=== | ===2020 [https://pubmed.ncbi.nlm.nih.gov/33176942/ Abuse liability assessment of the JUUL system in four flavors relative to combustible cigarette, nicotine gum and a comparator electronic nicotine delivery system among adult smokers]=== | ||
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**Citation: Stiles MF, Campbell LR, Jin T, Graff DW, Fant RV, Henningfield JE. Assessment of the abuse liability of three menthol Vuse Solo electronic cigarettes relative to combustible cigarettes and nicotine gum. Psychopharmacology (Berl). 2018 Jul;235(7):2077-2086. doi: 10.1007/s00213-018-4904-x. Epub 2018 May 3. PMID: 29725702; PMCID: PMC6015619. | **Citation: Stiles MF, Campbell LR, Jin T, Graff DW, Fant RV, Henningfield JE. Assessment of the abuse liability of three menthol Vuse Solo electronic cigarettes relative to combustible cigarettes and nicotine gum. Psychopharmacology (Berl). 2018 Jul;235(7):2077-2086. doi: 10.1007/s00213-018-4904-x. Epub 2018 May 3. PMID: 29725702; PMCID: PMC6015619. | ||
***Acknowledgement: ClinicalTrials.gov identifier: NCT02664012. MF Stiles, LR Campbell, and T Jin are full-time employees of RAI Services Company. RAI Services Company is a wholly owned subsidiary of Reynolds American Inc., which is a wholly owned subsidiary of British American Tobacco plc. DW Graff is a full-time employee of Celerion and provided the original draft of the manuscript. RV Fant and JE Henningfield are full-time employees of PinneyAssociates, which provides consulting services on smoking cessation and tobacco harm minimization (including nicotine replacement therapy and electronic vapor products) to Niconovum, USA, Inc., RJ Reynolds Vapor Company, and RAI Services Company (all subsidiaries of Reynolds American Inc.). JE Henningfield also owns an interest in intellectual property for a novel nicotine medication. Through PinneyAssociates, Fant and Henningfield provide consulting services to pharmaceutical companies on abuse potential assessment, and the regulation of substances with a potential for abuse. | ***Acknowledgement: ClinicalTrials.gov identifier: NCT02664012. MF Stiles, LR Campbell, and T Jin are full-time employees of RAI Services Company. RAI Services Company is a wholly owned subsidiary of Reynolds American Inc., which is a wholly owned subsidiary of British American Tobacco plc. DW Graff is a full-time employee of Celerion and provided the original draft of the manuscript. RV Fant and JE Henningfield are full-time employees of PinneyAssociates, which provides consulting services on smoking cessation and tobacco harm minimization (including nicotine replacement therapy and electronic vapor products) to Niconovum, USA, Inc., RJ Reynolds Vapor Company, and RAI Services Company (all subsidiaries of Reynolds American Inc.). JE Henningfield also owns an interest in intellectual property for a novel nicotine medication. Through PinneyAssociates, Fant and Henningfield provide consulting services to pharmaceutical companies on abuse potential assessment, and the regulation of substances with a potential for abuse. | ||
===2017 [https://pubmed.ncbi.nlm.nih.gov/28634710/ Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combustible cigarettes, and nicotine gum: implications for abuse liability]=== | |||
*"In summary, this study is the most robust assessment of the abuse liability of ECs published to date and uses approaches similar to those found in classic abuse liability studies of pharmaceutical products, including multiple instruments to measure the subjective effects of product use, as well as nicotine uptake. Under the set of study conditions described herein, use of the three Vuse Solo ECs tended to result in subjective measures responses and nicotine uptake that were between those measured with use of combustible cigarettes and nicotine gum. In general, the results are consistent with the conclusions of others that the abuse liability of ECs as a category is less than that of combustible cigarettes but greater than for nicotine gum, and likely other nicotine replacement products' | |||
**Citation: Stiles MF, Campbell LR, Graff DW, Jones BA, Fant RV, Henningfield JE. Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combustible cigarettes, and nicotine gum: implications for abuse liability. Psychopharmacology (Berl). 2017 Sep;234(17):2643-2655. doi: 10.1007/s00213-017-4665-y. Epub 2017 Jun 20. PMID: 28634710; PMCID: PMC5548902. | |||
***Acknowledgment: Funding; This study was funded by RJ Reynolds Vapor Company through its affiliate RJ Reynolds Tobacco Company. COI; MF Stiles, LR Campbell, and BA Jones are full-time employees of RAI Services Company, which provides support across the Reynolds American Inc. operating companies. DW Graff is a full-time employee of Celerion and provided the original draft of this manuscript. RV Fant and JE Henningfield are full-time employees of PinneyAssociates, which provides consulting services on tobacco harm minimization (including nicotine replacement therapy and digital vapor products) to Niconovum USA, RJ Reynolds Vapor Company, and RAI Services Company (all subsidiaries of Reynolds American Inc.) In the past 3 years, PinneyAssociates has consulted to GlaxoSmithKline Consumer Healthcare on smoking cessation and NJOY on electronic cigarettes. JE Henningfield also owns an interest in intellectual property for a novel nicotine medication, an option for which has been sold to Niconovum USA. Through PinneyAssociates, Fant and Henningfield also provide consulting services to pharmaceutical companies on abuse potential assessment and the regulation of substances with a potential for abuse. | |||
===2015 [https://pubmed.ncbi.nlm.nih.gov/25561385/ Dependence levels in users of electronic cigarettes, nicotine gums and tobacco cigarettes]=== | ===2015 [https://pubmed.ncbi.nlm.nih.gov/25561385/ Dependence levels in users of electronic cigarettes, nicotine gums and tobacco cigarettes]=== | ||
| Line 215: | Line 246: | ||
**Citation: Houtsmuller EJ, Fant RV, Eissenberg TE, Henningfield JE, Stitzer ML. Flavor improvement does not increase abuse liability of nicotine chewing gum. Pharmacol Biochem Behav. 2002 Jun;72(3):559-68. doi: 10.1016/s0091-3057(02)00723-2. PMID: 12175452. | **Citation: Houtsmuller EJ, Fant RV, Eissenberg TE, Henningfield JE, Stitzer ML. Flavor improvement does not increase abuse liability of nicotine chewing gum. Pharmacol Biochem Behav. 2002 Jun;72(3):559-68. doi: 10.1016/s0091-3057(02)00723-2. PMID: 12175452. | ||
***Acknowledgement: This study was supported by SmithKline Beecham Consumer Healthcare. | ***Acknowledgement: This study was supported by SmithKline Beecham Consumer Healthcare. | ||
===2000 [https://pubmed.ncbi.nlm.nih.gov/10823399/ A comparison of the abuse liability and dependence potential of nicotine patch, gum, spray and inhaler]=== | |||
*"We conclude that abuse liability from all four NRT products was low. Subjective dependence was moderate and did not differ across products. Behavioural dependence was modest and was positively related to rate of nicotine delivery." | |||
**Citation: West R, Hajek P, Foulds J, Nilsson F, May S, Meadows A. A comparison of the abuse liability and dependence potential of nicotine patch, gum, spray and inhaler. Psychopharmacology (Berl). 2000 Apr;149(3):198-202. doi: 10.1007/s002130000382. PMID: 10823399. | |||
***Acknowledgment: This study was funded by Pharmacia and Upjohn, Sweden. | |||
===1997 [https://pubmed.ncbi.nlm.nih.gov/9160851/ Nicotine nasal spray and vapor inhaler: abuse liability assessment]=== | |||
*"Overall, results are consistent with the conclusion that the nicotine nasal spray and vapor inhaler are of substantially lower abuse liability than cigarettes in experienced cigarette smokers receiving initial exposure to these products." | |||
**Citation: Schuh KJ, Schuh LM, Henningfield JE, Stitzer ML. Nicotine nasal spray and vapor inhaler: abuse liability assessment. Psychopharmacology (Berl). 1997 Apr;130(4):352-61. doi: 10.1007/s002130050250. PMID: 9160851. | |||
***Acknowledgment: This work was supported by USPHS research grant DA03893 and training grant T32 DA07209 from the National Institute on Drug Abuse and conducted in collaboration with the NIDA Intramural Research Program Addiction Research Center. The authors thank Pharmacia Upjohn who kindly donated pharmaceutical supplies and conducted blood assays for this study. | |||
='''Novel Oral Products (Chewable)'''= | |||
===2021 [https://pubmed.ncbi.nlm.nih.gov/33502815/ Characterization of the Abuse Potential in Adult Smokers of a Novel Oral Tobacco Product Relative to Combustible Cigarettes and Nicotine Polacrilex Gum]=== | |||
*"The test products, under the conditions of this study, carry lower abuse potential than own-brand cigarettes and similar to nicotine polacrilex gum." | |||
**Citation: Liu J, Wang J, Vansickel A, Edmiston J, Graff D, Sarkar M. Characterization of the Abuse Potential in Adult Smokers of a Novel Oral Tobacco Product Relative to Combustible Cigarettes and Nicotine Polacrilex Gum. Clin Pharmacol Drug Dev. 2021 Mar;10(3):241-250. doi: 10.1002/cpdd.909. Epub 2021 Jan 27. PMID: 33502815; PMCID: PMC7986766. | |||
***Acknowledgment: J.L., J.W., A.V., J.E., and M.S. are employees of Altria Client Services LLC. D.G. was an employee of Celerion, Inc., who was contracted by Altria Client Services LLC to perform the study and analyze the study data. | |||
='''VLNC - Very Low Nicotine Cigarettes'''= | ='''VLNC - Very Low Nicotine Cigarettes'''= | ||
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