1 Treatment of Spit Tobacco Use Lowell C. Dale, MD Jon O. Ebbert, MD, MSc Assistant Professors of...

Treatment of Spit Tobacco UseTreatment of Spit Tobacco Use

Lowell C. Dale, MDLowell C. Dale, MD

Jon O. Ebbert, MD, MScJon O. Ebbert, MD, MSc

Assistant Professors of Medicine, Mayo Medical SchoolAssistant Professors of Medicine, Mayo Medical School

Community Internal Medicine & Nicotine Dependence CenterCommunity Internal Medicine & Nicotine Dependence Center

Lowell C. Dale, MDLowell C. Dale, MD

Jon O. Ebbert, MD, MScJon O. Ebbert, MD, MSc

Assistant Professors of Medicine, Mayo Medical SchoolAssistant Professors of Medicine, Mayo Medical School

Community Internal Medicine & Nicotine Dependence CenterCommunity Internal Medicine & Nicotine Dependence Center

Dale, Ebbert. Workshop. Treatment of Spit Tobacco Use. 2

Goal of WorkshopGoal of Workshop

• Explore & share collective knowledge of spit tobacco dependence & treatment

Spit Tobacco - Definitions

• ““Smokeless” - industry termSmokeless” - industry term– Implies safetyImplies safety– Should be replaced with “spit”Should be replaced with “spit”

• SnuffSnuff– DryDry– Moist (i.e., Copenhagen, Skoal)Moist (i.e., Copenhagen, Skoal)

• Chewing tobaccoChewing tobacco– Loose leaf (i.e., Redman)Loose leaf (i.e., Redman)– PlugsPlugs– TwistsTwists

Top Selling ST Brands, Thousands of PoundsTop Selling ST Brands, Thousands of Pounds

MOIST SNUFF AND FINE CUT TOBACCO BRANDS

Brand Company 1997

SKOAL US Tobacco 22,213.0

COPENHEGAN US Tobacco 20,550.0

KODIAK Conwood 6,428.0

LOOSE LEAF CHEWING TOBACCO BRANDS

Brand Company 1997

RED MAN Swedish Match 11,001.0

LEVI GARRETT Conwood 9.874.0

BEECH NUT National Tobacco 7,118.0

Maxwell Consumer Report

Background - Marketing & SalesBackground - Marketing & Sales

• In 1999, newspaper, magazine, and point of sale advertising approached $170 million.

• Annual revenues from ST sales peaked at $1,940 million.

[Federal Trade Commission, 2001]

• In 1999, newspaper, magazine, and point of sale advertising approached $170 million.

• Annual revenues from ST sales peaked at $1,940 million.

[Federal Trade Commission, 2001]

Who Uses ST?Who Uses ST?

Background - PrevalenceBackground - Prevalence

• In the U.S., 1991:• 5.3 million people regularly used ST

• By the year 2000, among individuals > 12 years of age:

• 7.6 million regular ST users [USDHSS, 2000; U.S. Census, 2000]

• In the U.S., 1991:• 5.3 million people regularly used ST

• By the year 2000, among individuals > 12 years of age:

• 7.6 million regular ST users [USDHSS, 2000; U.S. Census, 2000]

• Among individuals > 12 years of age:• 6.5% males• 0.5% females

• 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]

• Among individuals > 12 years of age:• 6.5% males• 0.5% females

• 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]

• 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]

• The highest prevalence of ST use is found among:• White males between the ages of 18 and 25• 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]

• Use is reported to be higher in small towns than in large cities [Marcus, 1989 #909]

• The highest prevalence of ST use is found among:• White males between the ages of 18 and 25• White males between the ages of 25 and 35 [Smith, 1999 #3]

• Among the population 12 years of age or older who had used ST in the last month:

• 0.8% of the Hispanic population • 1.3% among Hispanic males

• 2.0% of the African-Americans• 2% among African-American males, and

• 0.2% among all women [NHSDA, 1998 #2173].

• The prevalence of ST use within the past year among college-age women was 1.3% [Rigotti, 2000 #2031].

• Among the population 12 years of age or older who had used ST in the last month:

• 0.8% of the Hispanic population • 1.3% among Hispanic males

• 2.0% of the African-Americans• 2% among African-American males, and

• 0.2% among all women [NHSDA, 1998 #2173].

• The prevalence of ST use within the past year among college-age women was 1.3% [Rigotti, 2000 #2031].

Background - Health ImplicationsBackground - Health Implications

• Use of ST products can lead to:• Nicotine addiction

• ST use is a risk factor for:• Periodontal disease• Tooth decay• Oral cancer [National Institute of Health, 1986]

• Use of ST products can lead to:• Nicotine addiction

• ST use is a risk factor for:• Periodontal disease• Tooth decay• Oral cancer [National Institute of Health, 1986]

Spit Tobacco: Health EffectsSpit Tobacco: Health Effects

• Bad Breath

• Stained Teeth

• Poor Wound Healing

• Periodontal Disease•gingival recession•tooth (bone

attachment) loss•erosion of enamel•dental caries

• Bad Breath

• Stained Teeth

• Poor Wound Healing

• Periodontal Disease•gingival recession•tooth (bone

attachment) loss•erosion of enamel•dental caries

LeukoplakiaLeukoplakia

• Silverman et al., 1984• Followed 257 patients w/ leukoplakia• 7.2 years on average• 45 (17.5%) developed SCC

• Conservative estimates: 3-6%

• Silverman et al., 1984• Followed 257 patients w/ leukoplakia• 7.2 years on average• 45 (17.5%) developed SCC

• Conservative estimates: 3-6%

Spit Tobacco: Health EffectsSpit Tobacco: Health Effects

Oral Cancer

• 4 fold increase in moderate ST Users• 7 fold increase in

heavy ST Users

Oral Cancer

• 4 fold increase in moderate ST Users• 7 fold increase in

heavy ST Users

• May increase the risk for cancer of the:• Esophagus• Larynx• Stomach• Pancreas [Connolly, 1986; Mattson, 1989]

• ST use associated with risk factors for cardiovascular disease

• Elevated blood pressure and cholesterol levels.[Bolinder, 1992; Bolinder, 1994; Tucker, 1989; National Institute of Health, 1986]

• Laboratory rat models - ST extracts exhibit adverse effects on fetal viability and development.[Paulson, 1988]

• ST use associated with risk factors for cardiovascular disease

• Elevated blood pressure and cholesterol levels.[Bolinder, 1992; Bolinder, 1994; Tucker, 1989; National Institute of Health, 1986]

• Laboratory rat models - ST extracts exhibit adverse effects on fetal viability and development.[Paulson, 1988]

ST PharmacologyST Pharmacology

Biomarkers: Nicotine vs. CotinineBiomarkers: Nicotine vs. Cotinine

• Nicotine• Direct measurement of the addictive drug• Extensive first pass hepatic metabolism• Half-life 120 minutes

• Cotinine• Major metabolite of nicotine• Pharmacologically inactive• Quantitative marker of nicotine intake• Pre-abstinence levels correlate with withdrawal and

treatment outcome in smokers• Half-life 18-20 hours

• Clinically more practical to measure

• Nicotine• Direct measurement of the addictive drug• Extensive first pass hepatic metabolism• Half-life 120 minutes

• Cotinine• Major metabolite of nicotine• Pharmacologically inactive• Quantitative marker of nicotine intake• Pre-abstinence levels correlate with withdrawal and

treatment outcome in smokers• Half-life 18-20 hours

• Clinically more practical to measure

CotinineCotinine

• Serum cotinine concentrations have been shown to be associated with relapse to smoking and level of dependence in smokers.

• ST users swallow a large amount of nicotine• First-pass hepatic metabolism• Cotinine levels may not accurately reflect

levels of CNS exposure to nicotine

• Serum cotinine concentrations have been shown to be associated with relapse to smoking and level of dependence in smokers.

• ST users swallow a large amount of nicotine• First-pass hepatic metabolism• Cotinine levels may not accurately reflect

levels of CNS exposure to nicotine

Spit Tobacco PharmacologySpit Tobacco Pharmacology

• Absorbed dose (bioavailability) of nicotine is twice that obtained from smoking a cigarette:

chewing tobacco 4.5 mg

moist snuff 3.6 mg

4 mg nicotine gum 1.9 mg

cigarette 1.8 mg

• Absorbed dose (bioavailability) of nicotine is twice that obtained from smoking a cigarette:

chewing tobacco 4.5 mg

moist snuff 3.6 mg

4 mg nicotine gum 1.9 mg

cigarette 1.8 mg

• Slower absorption than with smoking

• Peak concentration at 30 minutes

• Persistent absorption for up to 60 minutes after tobacco removed

• slow release from mucus membranes• absorption of swallowed nicotine

• Slower absorption than with smoking

• Peak concentration at 30 minutes

• Persistent absorption for up to 60 minutes after tobacco removed

• slow release from mucus membranes• absorption of swallowed nicotine

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.

Dale, Ebbert. Workshop. Treatment of Spit Tobacco Use. 26Benowitz et al, 1989.

ST Characteristics Affecting Nicotine Blood LevelsST Characteristics Affecting Nicotine Blood Levels

• Concentration of nicotine in ST product

• Size of the tobacco cuttings• Long cut• Fine cut (higher)

• Lower acid level of product - higher free nicotine

• Concentration of nicotine in ST product

• Size of the tobacco cuttings• Long cut• Fine cut (higher)

• Lower acid level of product - higher free nicotine

Nicotine Content of Tobacco ProductsNicotine Content of Tobacco Products

Dose Product pH N mg/g % free N

Low Skoal Bandit 6.9 7.5 7.0

Hawken 5.7 3.2 0.5

Medium Skoal long 7.4 10.3-11.4 19.0-23.0

Med. high Skoal fine cut 7.6 10.4 28.0

High Kodiak 8.2 10.9 60.0

Copenhagen 8.6 11.4 79.0

Hatsukami & Severson. Nicotine &Tobacco Research.1999;1:21-44.

Dose Product pH N mg/g % free N

Low Skoal Bandit 6.9 7.5 7.0

Hawken 5.7 3.2 0.5

Medium Skoal long 7.4 10.3-11.4 19.0-23.0

Med. high Skoal fine cut 7.6 10.4 28.0

High Kodiak 8.2 10.9 60.0

Copenhagen 8.6 11.4 79.0

Hatsukami & Severson. Nicotine &Tobacco Research.1999;1:21-44.

CDC, 1999.

Free Nicotine as a Function of pH

Fant, RV et al. Pharmacokinetics and pharmacodynamics of moist snuff in humans. Tobacco Control 1999; 8: 387-392.

Nicotine PharmacologyDifferent ST Products

ST Dependence & WithdrawalST Dependence & Withdrawal

Measuring Dependence in ST UsersMeasuring Dependence in ST Users

• Predictors of nicotine dependence (modified FTQ)• Using ST within 30 minutes of waking up• Using ST when sick/mouth sores• ST in mouth > 30 minutes• Intentionally swallowing tobacco juice• ST in mouth all day• Strong cravings when abstinent • Greater than 15 dips/day

Boyle, 1995

Frequency of Withdrawal Symptoms in ST UsersFrequency of Withdrawal Symptoms in ST Users

• 85% Strong need/urge

• 63% Irritability

• 55% Restless

• 41% Concentration difficulties

• 39% Hunger

• 9% Sadness/depressed

• 85% Strong need/urge

• 63% Irritability

• 55% Restless

• 41% Concentration difficulties

• 39% Hunger

• 9% Sadness/depressed

What are Challenges to Treating or Addressing the Needs of ST Users?What are Challenges to Treating or Addressing the Needs of ST Users?

What are Potential Solutions?What are Potential Solutions?

Literature ReviewLiterature Review

• Question:

“What interventions are effective for ST users?”

• Searched for and identified all randomized controlled trials treating ST users only.

• Question:

“What interventions are effective for ST users?”

• Searched for and identified all randomized controlled trials treating ST users only.

Literature Review: ConclusionsLiterature Review: ConclusionsLiterature Review: ConclusionsLiterature Review: Conclusions

• Meta-analyses:

• Bupropion SR may be an effective intervention for ST users.

• NRT may be an effective intervention for ST users.

• Behavioral interventions are effective. • Among the behavioral interventions, the use of an

oral examination appears to be associated with the greatest treatment effect.

• Meta-analyses:

• Bupropion SR may be an effective intervention for ST users.

• NRT may be an effective intervention for ST users.

• Behavioral interventions are effective. • Among the behavioral interventions, the use of an

oral examination appears to be associated with the greatest treatment effect.

Ebbert et al., 2002. Addiction.

Literature Review: ConclusionsLiterature Review: ConclusionsLiterature Review: ConclusionsLiterature Review: Conclusions

• Behavioral Interventions with largest effect:

• Severson, 1998: Usual dental care and office intervention (advice to quit, quit date setting), self-help materials (pamphlets and oral replacement), self-help video & telephone support compared with usual care.

• Walsh, 1999: Oral examination with feedback, photos of ST effects, advice to quit, self-help manual, optional brief counseling (e.g., set quit date, triggers, withdrawal discussion), optional nicotine gum, & telephone support.

• Behavioral Interventions with largest effect:

• Severson, 1998: Usual dental care and office intervention (advice to quit, quit date setting), self-help materials (pamphlets and oral replacement), self-help video & telephone support compared with usual care.

• Walsh, 1999: Oral examination with feedback, photos of ST effects, advice to quit, self-help manual, optional brief counseling (e.g., set quit date, triggers, withdrawal discussion), optional nicotine gum, & telephone support.

Ebbert et al., 2002. Addiction.

Nicotine Patch Percentage Replacement

Evidence for Inadequate ReplacementEvidence for Inadequate Replacement

Dale et al., 1995.

High Dose NRTInitial Nicotine Patch Dosing Schedule

Percentage ReplacementPercentage Replacement

• Percentage replacement:

steady state nicotine x 100

baseline nicotine

• Monitor for therapeutic/side effects.

• Percentage replacement:

steady state nicotine x 100

baseline nicotine

• Monitor for therapeutic/side effects.

Percentage ReplacementPercentage Replacement

• Therapeutic drug monitoring with goal of 100% replacement

• ST: serum nicotine test of choice

• Serum nicotine at baseline• Ad libitum ST use

• Choose dose and recheck serum nicotine after 3 days• Steady state

• Therapeutic drug monitoring with goal of 100% replacement

• ST: serum nicotine test of choice

• Serum nicotine at baseline• Ad libitum ST use

• Choose dose and recheck serum nicotine after 3 days• Steady state

Snuff SubstitutesSnuff Substitutes

• Young’s Chew

• Smokey Mountain

• Golden Eagle

• Oregon Mint

• Winner’s Edge

• Bac-Off

• Jerky

• Sunflower Seeds

• Young’s Chew

• Smokey Mountain

• Golden Eagle

• Oregon Mint

• Winner’s Edge

• Bac-Off

• Jerky

• Sunflower Seeds

Recommended ST Treatment ApproachRecommended ST Treatment Approach

1) Behavioral treatment• Oral examination• +/- oral replacement products

2) Bupropion• 150 mg po qd x 3 days then bid• Quit 1 week later• Continue for 3-6 months

3) Tailored nicotine patch therapy• +/- gum for self-titration

1) Behavioral treatment• Oral examination• +/- oral replacement products

2) Bupropion• 150 mg po qd x 3 days then bid• Quit 1 week later• Continue for 3-6 months

3) Tailored nicotine patch therapy• +/- gum for self-titration

“Paul”“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

• 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

• 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

• 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

• 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.

• Month 4: Continuous abstinence.

• 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.

• Month 4: Continuous abstinence.

• Pilot project

• 8-day inpatient program

• Didactics, group therapy/individual therapy

• Tailored pharmacotherapy

• Combination (bupropion & NRT)

• Percentage replacement

• Dental hygienist visit and a dental examination with photographs

of suspicious lesions.

Residential Treatment Program

• Oral photographs - individualized feedback

Residential Treatment Program

• 3 programs - January, February, June

• 24 male ST users

• Median age (IQR): 39 (33-69)

• Median ST use (IQR): 3.5 (2-7) cans/pouches per wk

Results

Case StudiesCase Studies

Case 1: 16 year-old male Case 1: 16 year-old male

• One pouch Redman Leaf chewing tobacco and/or one tin of Copenhagen per three days x 3 years

• Reason for visit: Second violation for spit tobacco use on school grounds. Off baseball team till addresses tobacco through a program. Mom concerned about use

• History: Hx of asthma, depression, ADHD; sees Psychiatrist, medications - Ritalin

• One pouch Redman Leaf chewing tobacco and/or one tin of Copenhagen per three days x 3 years

• Reason for visit: Second violation for spit tobacco use on school grounds. Off baseball team till addresses tobacco through a program. Mom concerned about use

• History: Hx of asthma, depression, ADHD; sees Psychiatrist, medications - Ritalin

• Attempts: Few recalled. Longest abstinence: 3 days

• Withdrawal: more irritable and depressed

• Mood: Likes to see what he can get away with. Most friends use chew; likes to use with them. Thinks he is being treated unfairly.

• Barriers: boredom, peers, perception of enhanced performance

• Attempts: Few recalled. Longest abstinence: 3 days

• Withdrawal: more irritable and depressed

• Mood: Likes to see what he can get away with. Most friends use chew; likes to use with them. Thinks he is being treated unfairly.

• Barriers: boredom, peers, perception of enhanced performance

How Should We Treat this ST User?How Should We Treat this ST User?

• Seven cans of Copenhagen per week for 15 years

• Reason for visit: wishes to quit because he is concerned about cancer.

• History: Hx of alcoholism associated with withdrawal.

• Seven cans of Copenhagen per week for 15 years

• Reason for visit: wishes to quit because he is concerned about cancer.

• History: Hx of alcoholism associated with withdrawal.

• Attempts: none

• Withdrawal: intense cravings

• Barriers: fells it helps keep him motivated at work; outdoor activities (hunting, fishing) are associated with use as well.

• Attempts: none

• Withdrawal: intense cravings

• Barriers: fells it helps keep him motivated at work; outdoor activities (hunting, fishing) are associated with use as well.

How Should We Treat this ST User?How Should We Treat this ST User?

Has this workshop changed your practice or approach to ST users?Has this workshop changed your practice or approach to ST users?

1 Treatment of Spit Tobacco Use Lowell C. Dale, MD Jon O. Ebbert, MD, MSc Assistant Professors of...

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