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© 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Smokeless (Spit) Tobacco Use: Comprehensive Treatment Model Lowell C. Dale,

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1 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Smokeless (Spit) Tobacco Use: Comprehensive Treatment Model Lowell C. Dale, MD Jon O. Ebbert, MD, MSc Assistant Professors of Medicine Mayo Clinic College of Medicine Nicotine Dependence Center Lowell C. Dale, MD Jon O. Ebbert, MD, MSc Assistant Professors of Medicine Mayo Clinic College of Medicine Nicotine Dependence Center

2 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Goals & Objectives Review ST definitions & products Review ST definitions & products Discuss the prevalence of ST use Discuss the prevalence of ST use Describe ST pharmacology Describe ST pharmacology Discuss ST dependence measures and withdrawal Discuss ST dependence measures and withdrawal Review recommended treatments for ST use Review recommended treatments for ST use Review ST definitions & products Review ST definitions & products Discuss the prevalence of ST use Discuss the prevalence of ST use Describe ST pharmacology Describe ST pharmacology Discuss ST dependence measures and withdrawal Discuss ST dependence measures and withdrawal Review recommended treatments for ST use Review recommended treatments for ST use

3 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED ST Definitions & Products

4 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Spit Tobacco - Definitions “Smokeless” - industry term“Smokeless” - industry term –Implies safety –Could be replaced with “spit” Chewing tobaccoChewing tobacco –Loose leaf (i.e., Redman) –Plugs –Twists SnuffSnuff –Moist (i.e., Copenhagen, Skoal) –Dry (i.e., Honest, Honey bee, Navy, Square)

5 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Smokeless Brand Used Most Often in Last Month 78.5% National Household Survey on Drug Abuse, 2000

6 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Preferred Snuff Products National Household Survey on Drug Abuse, 2001

7 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Chewing Tobacco Products

8 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Prevalence of ST Use

9 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Background - Prevalence In the U.S., 1991: In the U.S., 1991: 5.3 million people regularly used ST 5.3 million people regularly used ST By the year 2001, among individuals > 12 years of age: By the year 2001, among individuals > 12 years of age: 7.3 million regular ST users [ Results from the 2001 National Household Survey on Drug Abuse: Volume I. Summary of National Findings (Office of Applied Studies, NHSDA Series H-17, DHHS Publication No. SMA 02-3758). Rockville, MD.] 7.3 million regular ST users [ Results from the 2001 National Household Survey on Drug Abuse: Volume I. Summary of National Findings (Office of Applied Studies, NHSDA Series H-17, DHHS Publication No. SMA 02-3758). Rockville, MD.] In the U.S., 1991: In the U.S., 1991: 5.3 million people regularly used ST 5.3 million people regularly used ST By the year 2001, among individuals > 12 years of age: By the year 2001, among individuals > 12 years of age: 7.3 million regular ST users [ Results from the 2001 National Household Survey on Drug Abuse: Volume I. Summary of National Findings (Office of Applied Studies, NHSDA Series H-17, DHHS Publication No. SMA 02-3758). Rockville, MD.] 7.3 million regular ST users [ Results from the 2001 National Household Survey on Drug Abuse: Volume I. Summary of National Findings (Office of Applied Studies, NHSDA Series H-17, DHHS Publication No. SMA 02-3758). Rockville, MD.]

10 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Background - Prevalence Among individuals > 12 years of age: Among individuals > 12 years of age: 6.3% males 6.3% males 0.4% females [[Results from the 2001 National Household Survey on Drug Abuse: Volume I. Summary of National Findings (Office of Applied Studies, NHSDA Series H-17, DHHS Publication No. SMA 02-3758). Rockville, MD.] 0.4% females [[Results from the 2001 National Household Survey on Drug Abuse: Volume I. Summary of National Findings (Office of Applied Studies, NHSDA Series H-17, DHHS Publication No. SMA 02-3758). Rockville, MD.] Highest rates of current ST use are found in American Indians and Alaska Natives. Highest rates of current ST use are found in American Indians and Alaska Natives. Northern Plains Native Americans: 25% prevalence of adult men [USDHHS, 1998] Northern Plains Native Americans: 25% prevalence of adult men [USDHHS, 1998] Among individuals > 12 years of age: Among individuals > 12 years of age: 6.3% males 6.3% males 0.4% females [[Results from the 2001 National Household Survey on Drug Abuse: Volume I. Summary of National Findings (Office of Applied Studies, NHSDA Series H-17, DHHS Publication No. SMA 02-3758). Rockville, MD.] 0.4% females [[Results from the 2001 National Household Survey on Drug Abuse: Volume I. Summary of National Findings (Office of Applied Studies, NHSDA Series H-17, DHHS Publication No. SMA 02-3758). Rockville, MD.] Highest rates of current ST use are found in American Indians and Alaska Natives. Highest rates of current ST use are found in American Indians and Alaska Natives. Northern Plains Native Americans: 25% prevalence of adult men [USDHHS, 1998] Northern Plains Native Americans: 25% prevalence of adult men [USDHHS, 1998]

11 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Past Month Tobacco Use among Persons Aged 12 or Older: 2001

12 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Background - Prevalence ST use is higher in rural areas than in urban areas [Centers for Disease Control and Prevention, 1993 #1820] ST use is higher in rural areas than in urban areas [Centers for Disease Control and Prevention, 1993 #1820] Use is reported to be higher in small towns than in large cities [Marcus, 1989 #909] Use is reported to be higher in small towns than in large cities [Marcus, 1989 #909] The highest prevalence of ST use (after Alaska Natives) is found among: The highest prevalence of ST use (after Alaska Natives) is found among: White males between the ages of 18 and 25 White males between the ages of 18 and 25 White males between the ages of 25 and 35 [Smith, 1999 #3] White males between the ages of 25 and 35 [Smith, 1999 #3] ST use is higher in rural areas than in urban areas [Centers for Disease Control and Prevention, 1993 #1820] ST use is higher in rural areas than in urban areas [Centers for Disease Control and Prevention, 1993 #1820] Use is reported to be higher in small towns than in large cities [Marcus, 1989 #909] Use is reported to be higher in small towns than in large cities [Marcus, 1989 #909] The highest prevalence of ST use (after Alaska Natives) is found among: The highest prevalence of ST use (after Alaska Natives) is found among: White males between the ages of 18 and 25 White males between the ages of 18 and 25 White males between the ages of 25 and 35 [Smith, 1999 #3] White males between the ages of 25 and 35 [Smith, 1999 #3]

13 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Background - Prevalence Among the population 12 years of age or older who had used ST in the last month: Among the population 12 years of age or older who had used ST in the last month: 0.8% of the Hispanic population 0.8% of the Hispanic population 1.3% among Hispanic males 1.3% among Hispanic males 2.0% of the African-Americans 2.0% of the African-Americans 2% among African-American males 2% among African-American males 0.2% among women [NHSDA, 1998]. 0.2% among women [NHSDA, 1998]. 1.3% among women attending college [Rigotti, 2000] 1.3% among women attending college [Rigotti, 2000] Among the population 12 years of age or older who had used ST in the last month: Among the population 12 years of age or older who had used ST in the last month: 0.8% of the Hispanic population 0.8% of the Hispanic population 1.3% among Hispanic males 1.3% among Hispanic males 2.0% of the African-Americans 2.0% of the African-Americans 2% among African-American males 2% among African-American males 0.2% among women [NHSDA, 1998]. 0.2% among women [NHSDA, 1998]. 1.3% among women attending college [Rigotti, 2000] 1.3% among women attending college [Rigotti, 2000]

14 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Background - Marketing & Sales In 2001: In 2001: Advertising & Promotion = $236.7 million Advertising & Promotion = $236.7 million Amount sold = 112 million pounds Amount sold = 112 million pounds Sales revenues = $2.13 billion in 2001 Sales revenues = $2.13 billion in 2001 [Federal Trade Commission, 2001-3] In 2001: In 2001: Advertising & Promotion = $236.7 million Advertising & Promotion = $236.7 million Amount sold = 112 million pounds Amount sold = 112 million pounds Sales revenues = $2.13 billion in 2001 Sales revenues = $2.13 billion in 2001 [Federal Trade Commission, 2001-3]

15 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Adverse Health Effects

16 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Smokeless Tobacco - Health Consequences Report on Carcinogens, 10th Edition, National Toxicology Program, USDHHS Smokeless tobacco “Known to be a human carcinogen” Report on Carcinogens, 10th Edition, National Toxicology Program, USDHHS Smokeless tobacco “Known to be a human carcinogen”

17 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED ST - Health Consequences Carcinogens Carcinogens Aldehydes Aldehydes Tobacco-specific N-nitrosamines (TSNAs) Tobacco-specific N-nitrosamines (TSNAs) 7 types identified 7 types identified Polycyclic aromatic hydrocarbons Polycyclic aromatic hydrocarbons Polonium 210 Polonium 210 Carcinogens Carcinogens Aldehydes Aldehydes Tobacco-specific N-nitrosamines (TSNAs) Tobacco-specific N-nitrosamines (TSNAs) 7 types identified 7 types identified Polycyclic aromatic hydrocarbons Polycyclic aromatic hydrocarbons Polonium 210 Polonium 210

18 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED ST - Health Consequences Risk appears to be different in different parts of world Likely relates to the type of ST use U.S. - Snuff & chewing tobacco Scandinavia - snus (lower levels of TSNAs) India - mixed with more carcingens (i.e., betel) Africa - “toombak” (I.e., N. rustica + Na bicarbonate) Risk appears to be different in different parts of world Likely relates to the type of ST use U.S. - Snuff & chewing tobacco Scandinavia - snus (lower levels of TSNAs) India - mixed with more carcingens (i.e., betel) Africa - “toombak” (I.e., N. rustica + Na bicarbonate)

19 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Health Effects of ST: Systematic Review Electronic database search, references lists, smoking-related websites, and contacted experts Observational studies of ST use with > 500 subjects Cohorts Case-control Cross sectional studies Electronic database search, references lists, smoking-related websites, and contacted experts Observational studies of ST use with > 500 subjects Cohorts Case-control Cross sectional studies Critchley et al. Thorax. 2003; 58: 435-443.

20 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED SR: Oral and Pharyngeal Cancers - U.S. Data Location OR (95% CI) Cancer, Mouth and Gum 11.2 (4.1-30.7) A Gum & Buccal Mucosa 4.2 (2.6-6.7) B Larynx 7.3 (2.9-18.3) A Salivary gland 5.3 (1.2-23.4) A Location OR (95% CI) Cancer, Mouth and Gum 11.2 (4.1-30.7) A Gum & Buccal Mucosa 4.2 (2.6-6.7) B Larynx 7.3 (2.9-18.3) A Salivary gland 5.3 (1.2-23.4) A A - Stockwell et al, 1986 B- Winn et al., 1981

21 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED SR: Oral and Pharyngeal Cancers - U.S. Data Winn et al., 1981 Cancer of gum and buccal mucosa = dose response Cancer of gum and buccal mucosa = dose response > 50 years OR = 47.5 (95% CI: 9.1-249.5) 1-24 years: OR = 13.8 (95% CI: 1.9 to 98.0)

22 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED SR: Cancer Other Sites - U.S. Data Location OR (95% CI) Bladder 4.0 (1.1-14.2) Location OR (95% CI) Bladder 4.0 (1.1-14.2) Goodman et al., 1986

23 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED SR: Cardiovascular Disease - Scandinavia Current/exclusive use compared w/ never smokers 35-54 year olds: Ischemic heart disease: RR 2.0 (95% CI: 1.49-2.9) Cardiovascular death: RR 2.1 (95% CI: 1.5-2.9) 55-64 year olds: IHD: RR 1.2 (95% CI: 1.0-1.5) CVD: RR 1.1 (95% CI: 1.0-1.4) Current/exclusive use compared w/ never smokers 35-54 year olds: Ischemic heart disease: RR 2.0 (95% CI: 1.49-2.9) Cardiovascular death: RR 2.1 (95% CI: 1.5-2.9) 55-64 year olds: IHD: RR 1.2 (95% CI: 1.0-1.5) CVD: RR 1.1 (95% CI: 1.0-1.4) Bolinder et al., 1994

24 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED SR: Dental Disease - U.S. Data Dental disease = caries & periodontal disease Decayed root surfaces: OR 3.24 (95% CI: 2.0-4.4) A Periodontal disease: Attachment loss more common in ST users without oral lesions than non-users (33.6% vs. 27.4%, P < 0.05) B Dental disease = caries & periodontal disease Decayed root surfaces: OR 3.24 (95% CI: 2.0-4.4) A Periodontal disease: Attachment loss more common in ST users without oral lesions than non-users (33.6% vs. 27.4%, P < 0.05) B A - Tomar et al., 1999 B - Ernster et al., 1990

25 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED SR: Oral Cancer Deaths……… Critchley et al., 2003 Location, Location, Location

26 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED ST - Oral Lesions Leukoplakia Leukoplakia Erythroleukoplakia Erythroleukoplakia Oral cancer Oral cancer Dental disease Dental disease erosion of enamel erosion of enamel dental caries dental caries Periodontal Disease Periodontal Disease gingival recession gingival recession soft tissue/hard tissue loss soft tissue/hard tissue loss gingivitis gingivitis Leukoplakia Leukoplakia Erythroleukoplakia Erythroleukoplakia Oral cancer Oral cancer Dental disease Dental disease erosion of enamel erosion of enamel dental caries dental caries Periodontal Disease Periodontal Disease gingival recession gingival recession soft tissue/hard tissue loss soft tissue/hard tissue loss gingivitis gingivitis

27 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED ST - Oral Lesions Leukoplakia Leukoplakia Erythroleukoplakia Erythroleukoplakia Oral cancer Oral cancer Dental disease Dental disease erosion of enamel erosion of enamel dental caries dental caries Periodontal Disease Periodontal Disease gingival recession gingival recession soft tissue/hard tissue loss soft tissue/hard tissue loss gingivitis gingivitis Leukoplakia Leukoplakia Erythroleukoplakia Erythroleukoplakia Oral cancer Oral cancer Dental disease Dental disease erosion of enamel erosion of enamel dental caries dental caries Periodontal Disease Periodontal Disease gingival recession gingival recession soft tissue/hard tissue loss soft tissue/hard tissue loss gingivitis gingivitis

28 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED ST - Oral Lesions Leukoplakia Leukoplakia Erythroleukoplakia Erythroleukoplakia Oral cancer Oral cancer Dental disease Dental disease erosion of enamel erosion of enamel dental caries dental caries Periodontal Disease Periodontal Disease gingival recession gingival recession soft tissue/hard tissue loss soft tissue/hard tissue loss gingivitis gingivitis Leukoplakia Leukoplakia Erythroleukoplakia Erythroleukoplakia Oral cancer Oral cancer Dental disease Dental disease erosion of enamel erosion of enamel dental caries dental caries Periodontal Disease Periodontal Disease gingival recession gingival recession soft tissue/hard tissue loss soft tissue/hard tissue loss gingivitis gingivitis

29 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED ST - Oral Lesions Leukoplakia Leukoplakia Erythroleukoplakia Erythroleukoplakia Oral cancer Oral cancer Dental disease Dental disease erosion of enamel erosion of enamel dental caries dental caries Periodontal Disease Periodontal Disease gingival recession gingival recession soft tissue/hard tissue loss soft tissue/hard tissue loss gingivitis gingivitis Leukoplakia Leukoplakia Erythroleukoplakia Erythroleukoplakia Oral cancer Oral cancer Dental disease Dental disease erosion of enamel erosion of enamel dental caries dental caries Periodontal Disease Periodontal Disease gingival recession gingival recession soft tissue/hard tissue loss soft tissue/hard tissue loss gingivitis gingivitis

30 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED ST - Oral Lesions Leukoplakia Leukoplakia Erythroleukoplakia Erythroleukoplakia Oral cancer Oral cancer Dental disease Dental disease erosion of enamel erosion of enamel dental caries dental caries Periodontal Disease Periodontal Disease gingival recession gingival recession soft tissue/hard tissue loss soft tissue/hard tissue loss gingivitis gingivitis Leukoplakia Leukoplakia Erythroleukoplakia Erythroleukoplakia Oral cancer Oral cancer Dental disease Dental disease erosion of enamel erosion of enamel dental caries dental caries Periodontal Disease Periodontal Disease gingival recession gingival recession soft tissue/hard tissue loss soft tissue/hard tissue loss gingivitis gingivitis

31 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED ST Pharmacology

32 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Smokeless Tobacco Pharmacology Potential available nicotine is twice that obtained from smoking a cigarette: Potential available nicotine is twice that obtained from smoking a cigarette: chewing tobacco4.5 mg moist snuff3.6 mg 4 mg nicotine gum1.9 mg cigarette 1.8 mg Potential available nicotine is twice that obtained from smoking a cigarette: Potential available nicotine is twice that obtained from smoking a cigarette: chewing tobacco4.5 mg moist snuff3.6 mg 4 mg nicotine gum1.9 mg cigarette 1.8 mg

33 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Smokeless Tobacco Pharmacology 4.8 mg nicotine/gm of moist snuff x 30 gm/can = 144 mg 144 mg nicotine/(1.8 mg nicotine/cigarette) = 80 cigarettes 80 cigarettes/(20 cigarettes/pack) = 4 packs 1 can snuff = 4 packs of cigarettes 3 cans/day = As much nicotine as 12 packs of cigarettes

34 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Smokeless Tobacco Pharmacology Slower absorption than with smoking Slower absorption than with smoking Peak concentration at 30 minutes Peak concentration at 30 minutes Persistent absorption for up to 60 minutes after tobacco removed Persistent absorption for up to 60 minutes after tobacco removed slow release from mucous membranes slow release from mucous membranes absorption of swallowed nicotine absorption of swallowed nicotine Slower absorption than with smoking Slower absorption than with smoking Peak concentration at 30 minutes Peak concentration at 30 minutes Persistent absorption for up to 60 minutes after tobacco removed Persistent absorption for up to 60 minutes after tobacco removed slow release from mucous membranes slow release from mucous membranes absorption of swallowed nicotine absorption of swallowed nicotine

35 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Smokeless Tobacco Pharmacology Blood nicotine concentration (ng/ml) Benowitz, NL et al. Nicotine absorption and cardiovascular effects with smokeless tobacco use: comparison with cigarettes and nicotine gum. Clin Pharmacol Ther 1988; 44: 23-8. Benowitz et al, 1988.

36 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED

37 Benowitz et al, 1989.

38 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED ST Characteristics Affecting Nicotine Blood Levels Concentration of nicotine in ST product Concentration of nicotine in ST product Size of the tobacco cuttings Size of the tobacco cuttings Long cut Long cut Fine cut (higher) Fine cut (higher) Lower acid level of product - higher free nicotine Lower acid level of product - higher free nicotine Concentration of nicotine in ST product Concentration of nicotine in ST product Size of the tobacco cuttings Size of the tobacco cuttings Long cut Long cut Fine cut (higher) Fine cut (higher) Lower acid level of product - higher free nicotine Lower acid level of product - higher free nicotine

39 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED CDC, 1999. Free Nicotine as a Function of pH

40 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED UST’s “graduation strategy” in a UST document exhibited in the Marsee vs US Tobacco Company Lawsuit, 1986 Connolly, G. N. (1995). “The marketing of nicotine addiction by one oral snuff manufacturer.” Tob Control 4: 73-79.

41 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Fant, RV et al. Pharmacokinetics and pharmacodynamics of moist snuff in humans. Tobacco Control 1999; 8: 387-392. Impact of pH Manipulation

42 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Impact of pH Manipulation Likelihood of choosing a brand with higher nicotine content is related to: Increasing duration of use Increasing intensity of use Frequency of ST use [Tomar, 1995 #2892] ST users who have used higher nicotine-containing products are more likely to report: More nicotine withdrawal symptoms Continued use because of difficulty quitting Likelihood of choosing a brand with higher nicotine content is related to: Increasing duration of use Increasing intensity of use Frequency of ST use [Tomar, 1995 #2892] ST users who have used higher nicotine-containing products are more likely to report: More nicotine withdrawal symptoms Continued use because of difficulty quitting Tomar, S. L., G. A. Giovino, et al. (1995). “Smokeless tobacco brand preference and brand switching among US adolescents and young adults.” Tob Control 4: 67-72.

43 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED ST Dependence & Withdrawal

44 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Frequency of Withdrawal Symptoms in 162 ST Users Ebbert et al.

45 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Measuring Dependence in ST Users Predictors of nicotine dependence (modified FTQ) Predictors of nicotine dependence (modified FTQ) Using ST within 30 minutes of waking up Using ST within 30 minutes of waking up Higher number of tins per week Higher number of tins per week Always swallowing tobacco juice Always swallowing tobacco juice Predictors of nicotine dependence (modified FTQ) Predictors of nicotine dependence (modified FTQ) Using ST within 30 minutes of waking up Using ST within 30 minutes of waking up Higher number of tins per week Higher number of tins per week Always swallowing tobacco juice Always swallowing tobacco juice Boyle et al. Addictive Behaviors. Vol. 20, No. 4, pp. 443-450. 1995

46 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Measuring Dependence in ST Users Predictors of nicotine dependence (modified FTQ) Predictors of nicotine dependence (modified FTQ) Using ST within 30 minutes of waking up Using ST within 30 minutes of waking up Higher number of tins per week Higher number of tins per week Always swallowing tobacco juice Always swallowing tobacco juice Using in inappropriate places Using in inappropriate places Church, synagogue, mosque Church, synagogue, mosque Using ST when ill in bed Using ST when ill in bed Nicotine content Nicotine content Copenhagen > Skoal bandits Copenhagen > Skoal bandits Chewing more in the morning Chewing more in the morning Morning chews are harder to give up Morning chews are harder to give up Chewing more than 16 hours/day Chewing more than 16 hours/day Predictors of nicotine dependence (modified FTQ) Predictors of nicotine dependence (modified FTQ) Using ST within 30 minutes of waking up Using ST within 30 minutes of waking up Higher number of tins per week Higher number of tins per week Always swallowing tobacco juice Always swallowing tobacco juice Using in inappropriate places Using in inappropriate places Church, synagogue, mosque Church, synagogue, mosque Using ST when ill in bed Using ST when ill in bed Nicotine content Nicotine content Copenhagen > Skoal bandits Copenhagen > Skoal bandits Chewing more in the morning Chewing more in the morning Morning chews are harder to give up Morning chews are harder to give up Chewing more than 16 hours/day Chewing more than 16 hours/day Boyle et al. Addictive Behaviors. Vol. 20, No. 4, pp. 443-450. 1995

47 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Current Recommendations for Treatment

48 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Methods of Treating Smokeless Tobacco Use Behavioral Pharmacologic

49 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Literature Review “What interventions are effective for ST users?” “What interventions are effective for ST users?” Two systematic reviews of treatment: Two systematic reviews of treatment: Ebbert, J. O., L. C. Rowland, et al. (2003). “Treatments for spit tobacco use: a quantitative systematic review.” Addiction 98(5): 569-83. Ebbert, J. O., L. C. Rowland, et al. (2003). “Treatments for spit tobacco use: a quantitative systematic review.” Addiction 98(5): 569-83. Severson, H. H. (2003). “What have we learned from 20 years of research on smokeless tobacco cessation?” Am J Med Sci 326(4): 206-11. Severson, H. H. (2003). “What have we learned from 20 years of research on smokeless tobacco cessation?” Am J Med Sci 326(4): 206-11. “What interventions are effective for ST users?” “What interventions are effective for ST users?” Two systematic reviews of treatment: Two systematic reviews of treatment: Ebbert, J. O., L. C. Rowland, et al. (2003). “Treatments for spit tobacco use: a quantitative systematic review.” Addiction 98(5): 569-83. Ebbert, J. O., L. C. Rowland, et al. (2003). “Treatments for spit tobacco use: a quantitative systematic review.” Addiction 98(5): 569-83. Severson, H. H. (2003). “What have we learned from 20 years of research on smokeless tobacco cessation?” Am J Med Sci 326(4): 206-11. Severson, H. H. (2003). “What have we learned from 20 years of research on smokeless tobacco cessation?” Am J Med Sci 326(4): 206-11.

50 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Literature Review: Conclusions Severson, H. H. (2003). “What have we learned from 20 years of research on smokeless tobacco cessation?” Am J Med Sci 326(4): 206-11.

51 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Literature Review: Conclusions Meta-analyses: Meta-analyses: Behavioral interventions are effective. Behavioral interventions are effective. Bupropion SR is probably effective intervention for ST users. Bupropion SR is probably effective intervention for ST users. NRT may be an effective intervention for ST users. NRT may be an effective intervention for ST users. Among the behavioral interventions, the use of an oral examination appears to be associated with the greatest treatment effect. Among the behavioral interventions, the use of an oral examination appears to be associated with the greatest treatment effect. Meta-analyses: Meta-analyses: Behavioral interventions are effective. Behavioral interventions are effective. Bupropion SR is probably effective intervention for ST users. Bupropion SR is probably effective intervention for ST users. NRT may be an effective intervention for ST users. NRT may be an effective intervention for ST users. Among the behavioral interventions, the use of an oral examination appears to be associated with the greatest treatment effect. Among the behavioral interventions, the use of an oral examination appears to be associated with the greatest treatment effect. Ebbert, J. O., L. C. Rowland, et al. (2003). “Treatments for spit tobacco use: a quantitative systematic review.” Addiction 98(5): 569-83.

52 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Pharmacologic Treatment: Nicotine Patch Percentage Replacement

53 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Dale, et al. JAMA, 1995.

54 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Peak serum nicotine concentrations (ng/mL) Cans or pouches per week Patch dose Low 0-10 = 1 14 mg/d Intermediate 11-20 2-3 21or 22 mg/d High > 20 > 3 42 or 44 mg/d NRT for ST Users

55 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Recommended ST Treatment Approach 1) Behavioral treatment Oral examination Oral examination +/- oral replacement products +/- oral replacement products 2) Bupropion 150 mg po qd x 3 days then bid 150 mg po qd x 3 days then bid Quit 1 week later Quit 1 week later Continue for 3-6 months Continue for 3-6 months 3) Tailored nicotine patch therapy +/- gum/lozenge for self-titration +/- gum/lozenge for self-titration 1) Behavioral treatment Oral examination Oral examination +/- oral replacement products +/- oral replacement products 2) Bupropion 150 mg po qd x 3 days then bid 150 mg po qd x 3 days then bid Quit 1 week later Quit 1 week later Continue for 3-6 months Continue for 3-6 months 3) Tailored nicotine patch therapy +/- gum/lozenge for self-titration +/- gum/lozenge for self-titration

56 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Oral Exam Oral exam.pdf available at: http://www.nohic.nidcr.nih.gov/pdfs/OralPoster 2002.pdf Oral exam.pdf available at: http://www.nohic.nidcr.nih.gov/pdfs/OralPoster 2002.pdf

57 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Nicotine Lozenge Nicotine Polacrilex 2 mg 4 mg Dissolves in mouth over 20-30 minutes Delivers 25% more nicotine than the gum Nicotine Polacrilex 2 mg 4 mg Dissolves in mouth over 20-30 minutes Delivers 25% more nicotine than the gum

58 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Nicotine Lozenge Dosing 1-2 lozenges every 1-2 hours Minimum of 9/day Taper over 12 weeks 1-2 lozenges every 1-2 hours Minimum of 9/day Taper over 12 weeks

59 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Nicotine Lozenge Side-Effects Nausea (12-15%) Heartburn (5-6%) Hiccups (3-8%) Not to be chewed or swallowed whole Avoid eating or drinking food during and 15 minutes prior to use Nausea (12-15%) Heartburn (5-6%) Hiccups (3-8%) Not to be chewed or swallowed whole Avoid eating or drinking food during and 15 minutes prior to use

60 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Nicotine Gum Useful adjunct with intervention Useful adjunct with intervention Most effective with counseling Most effective with counseling 2 mg and 4 mg 2 mg and 4 mg “Chew and Park” “Chew and Park” Frequent use initially (10-15/day) Frequent use initially (10-15/day) Often used in combination with other NRT Often used in combination with other NRT Useful adjunct with intervention Useful adjunct with intervention Most effective with counseling Most effective with counseling 2 mg and 4 mg 2 mg and 4 mg “Chew and Park” “Chew and Park” Frequent use initially (10-15/day) Frequent use initially (10-15/day) Often used in combination with other NRT Often used in combination with other NRT

61 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Nicotine Gum Nicotine Gum: Side Effects mouth soreness hiccups stomach upset/nausea jaw aches mouth soreness hiccups stomach upset/nausea jaw aches

62 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Bupropion SR Bupropion SR Dosing 150 mg daily for 3-4 days then 150 mg twice a day for 3-4 days THEN STOP Tobacco 150 mg daily for 3-4 days then 150 mg twice a day for 3-4 days THEN STOP Tobacco

63 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Bupropion Side Effects Insomnia (35%) Dry mouth (13%) Anxiety (5%) Rash (2%) Seizures: 1/1000 Insomnia (35%) Dry mouth (13%) Anxiety (5%) Rash (2%) Seizures: 1/1000

64 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Bupropion Bupropion Seizure Risk History of seizures Previous head/CNS trauma Eating disorders (bulimia/anorexia nervosa) Neuroleptic medications High doses of Bupropion History of seizures Previous head/CNS trauma Eating disorders (bulimia/anorexia nervosa) Neuroleptic medications High doses of Bupropion

65 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Bupropion SR Bupropion SR Dosing Duration: 8-12 weeks Safe to use longer Taper is unnecessary Combination with NRT Duration: 8-12 weeks Safe to use longer Taper is unnecessary Combination with NRT

66 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Pilot project Pilot project 8-day inpatient program 8-day inpatient program Didactics, group therapy/individual therapy Didactics, group therapy/individual therapy Tailored pharmacotherapy Tailored pharmacotherapy Combination (bupropion & NRT) Combination (bupropion & NRT) Percentage replacement Percentage replacement Dental hygienist visit and a dental examination with photographs of suspicious lesions. Dental hygienist visit and a dental examination with photographs of suspicious lesions. Pilot project Pilot project 8-day inpatient program 8-day inpatient program Didactics, group therapy/individual therapy Didactics, group therapy/individual therapy Tailored pharmacotherapy Tailored pharmacotherapy Combination (bupropion & NRT) Combination (bupropion & NRT) Percentage replacement Percentage replacement Dental hygienist visit and a dental examination with photographs of suspicious lesions. Dental hygienist visit and a dental examination with photographs of suspicious lesions. Residential Treatment Program

67 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED 3-month self-reported continuous abstinence rate: 3-month self-reported continuous abstinence rate: 22/24 = 92% 22/24 = 92% 6-month self-reported continuous abstinence rate: 6-month self-reported continuous abstinence rate: 21/24 = 88% 21/24 = 88% 12-month biochemically-confirmed point prevalence tobacco abstinence rate: 12-month biochemically-confirmed point prevalence tobacco abstinence rate: 12/24 = 50% 12/24 = 50% 3-month self-reported continuous abstinence rate: 3-month self-reported continuous abstinence rate: 22/24 = 92% 22/24 = 92% 6-month self-reported continuous abstinence rate: 6-month self-reported continuous abstinence rate: 21/24 = 88% 21/24 = 88% 12-month biochemically-confirmed point prevalence tobacco abstinence rate: 12-month biochemically-confirmed point prevalence tobacco abstinence rate: 12/24 = 50% 12/24 = 50% Results

68 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED “Paul” 34 years old Spit tobacco for 28 years Now: Copenhagen 1 tin/day Quit attempts: 4-5, longest 2 days Exam: plaque, supragingival calculus, erythema and inflamed tissue, areas of leukoplakia on the labial vestibule opposite lower incisors 34 years old Spit tobacco for 28 years Now: Copenhagen 1 tin/day Quit attempts: 4-5, longest 2 days Exam: plaque, supragingival calculus, erythema and inflamed tissue, areas of leukoplakia on the labial vestibule opposite lower incisors

69 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED “Paul” Nicotine Level: 40 ng/ml Cotinine Level: 402 ng/ml Treatment: Bupropion SR 150 bid Residential Program 42 mg nicotine patch Nicotine gum as needed Snuff substitute as needed Nicotine Level: 40 ng/ml Cotinine Level: 402 ng/ml Treatment: Bupropion SR 150 bid Residential Program 42 mg nicotine patch Nicotine gum as needed Snuff substitute as needed

70 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED “Paul” Day 2: Difficulty sleeping, strong cravings, constantly thinking about Copenhagen. Using mint snuff oral substitute. Plan: Increase to 56 mg nicotine patch/day Day 2: Difficulty sleeping, strong cravings, constantly thinking about Copenhagen. Using mint snuff oral substitute. Plan: Increase to 56 mg nicotine patch/day

71 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED “Paul” Day 4: Slept much better. Significant decrease in cravings. Continues with snuff substitute. Nicotine level: 37 ng/ml Cotinine level: 318 ng/ml Day 4: Slept much better. Significant decrease in cravings. Continues with snuff substitute. Nicotine level: 37 ng/ml Cotinine level: 318 ng/ml

72 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED “Paul” Day 8: Dismiss on 56mg/day nicotine patch for 4 weeks and then taper as tolerated; bupropion SR 150 bid for at least 3 months. Follow-up with counselor regularly by telephone.

73 © 2003 MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH. ALL RIGHTS RESERVED Goals & Objectives Review ST definitions & products Review ST definitions & products Discuss the prevalence of ST use Discuss the prevalence of ST use Describe ST pharmacology Describe ST pharmacology Discuss ST dependence measures and withdrawal Discuss ST dependence measures and withdrawal Review recommended treatments for ST use Review recommended treatments for ST use Review ST definitions & products Review ST definitions & products Discuss the prevalence of ST use Discuss the prevalence of ST use Describe ST pharmacology Describe ST pharmacology Discuss ST dependence measures and withdrawal Discuss ST dependence measures and withdrawal Review recommended treatments for ST use Review recommended treatments for ST use


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