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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: 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. | **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. | ***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)'''= | ='''Novel Oral Products (Chewable)'''= | ||
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