Safety and efficacy of the nicotine patch and gum for the treatment of adolescent tobacco addiction
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Safety and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Addiction. Tony Nguyen, PGY2. Case. Peter Gibbons 18 y/o male presenting for college physical Doing well with no complaints No significant PMHx/PSHx No medications Immunizations are UTD.

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Safety and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Addiction

Tony Nguyen, PGY2


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Case Treatment of Adolescent Tobacco Addiction

  • Peter Gibbons 18 y/o male presenting for college physical

  • Doing well with no complaints

  • No significant PMHx/PSHx

  • No medications

  • Immunizations are UTD


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  • Home: Parents, 2 younger siblings Treatment of Adolescent Tobacco Addiction

  • Education: Starting college at Va Tech, plans on engineering/computer science degree

  • Activities: Working at father’s software company this summer for money

  • Drugs: Denies drugs/EtOH, but admits to 3 yr hx of smoking 1 ppd. Wants to quit before college.

  • SSS: Denies SI/HI, +SA (2 yr relationship, always uses protection), and feels safe at home.


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His only question: Treatment of Adolescent Tobacco Addiction

  • Does nicotine replacement therapy work, and how safe is it?


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Smoking Fast Facts Treatment of Adolescent Tobacco Addiction

  • Nearly 21% of U.S. adults (44.5 million people) are cigarette smokers.

  • Responsible for an estimated 438,000 deaths per year (1 in 5 deaths)

  • An estimated 38,000 of these deaths are the result of secondhand smoke exposure


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Smoking Fast Facts Treatment of Adolescent Tobacco Addiction

  • Cigarette smoking results in more than $167 billion in costs annually, based on lost productivity ($92.4 billion) and health care expenditures ($75.5 billion)

  • In 2003 the cigarette industry spent almost $15.2 billion on advertising and promotional expenses - $41 million per day.


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More Smoking Fast Facts* Treatment of Adolescent Tobacco Addiction

  • Kills more people than car accidents, alcohol, homicide, suicide, drugs, fires, and AIDS combined

  • Single most preventable cause of disease in the US

  • Largest single cause of premature death in developed world

    *W. Adelman


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Teenage Smoking Fast Facts Treatment of Adolescent Tobacco Addiction

  • Almost 22% of high school students in the United States are current cigarettes smokers.

  • Each day, an estimated 1,500 teens younger than 18 begin smoking on a daily basis.


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Smoking cessation studies chemically dependent under DSM IV mental health standards

  • 1998: Prev Med: 1,210 established smokers in 6,427 polled

    • 67% wanted to quit

    • 60% of those attempted to quit

    • 3% achieved cessation beyond 12 months


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Studies chemically dependent under DSM IV mental health standards

  • 2001: Massachusetts: School nurse intervention

    • Study between 71 HS showed that those with nurse intervention had 8x greater odds at quitting at 6 weeks and 6x greater at 12 weeks


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Studies chemically dependent under DSM IV mental health standards

  • Hypnosis

    • Int J Clin Exp Hypn Jul 2006

      • Scott and White Memorial Hospital study

      • 8 visits over 2 months of hypnotherapy

      • 40% cessation after end of study and out to 26 weeks


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Studies chemically dependent under DSM IV mental health standards

  • Korea: Acupuncture!

    • 159 HS students treated with “anti-smoking” acu-points on the ear for 4 weeks

    • Control group – 79 students treated at other sites on the ear

    • Result: 1 case of success (0.6%) in case group, zero in control group


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Studies chemically dependent under DSM IV mental health standards

  • Bupropion plus Nicotine patch

    • Journal of Consulting and Clinical Psych 2004

    • Abstinence rates at weeks 10 and 26:

      • Patch + Bupropion: 23 % and 8%

      • Patch + Placebo: 28% and 7%

    • Bupropion not effective

    • But study found that large majority of teens in both groups reduced consumption and maintained the reduction over time with the nicotine replacement


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Studies chemically dependent under DSM IV mental health standards

  • J. Addiction 2005 – JW May et al…

    • 30% of those attempting NRT had quit

    • 39% of those NOT attempting NRT had quit


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Back to the original question… chemically dependent under DSM IV mental health standards

  • Is Nicotine replacement safe and efficacious for teens?


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Safety and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Addiction

  • Participants

  • Methods

  • Results

  • Conclusions


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Participants Treatment of Adolescent Tobacco Addiction

  • Inner city Baltimore

  • Outreach and recruitment over 4 year via media, schools, and churches

  • Eligibility based on history, physical exam, and laboratory screening


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Participants Treatment of Adolescent Tobacco Addiction

  • Inclusion Criteria:

    • General good health

    • Ages 13 to 17

    • Smoked ≥ 10 CPD for ≥ 6 months

    • Minimal score 5 of Fagerstrom Test of Nicotine Dependence (FTND)

    • Highly motivated to stop smoking


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Participants Treatment of Adolescent Tobacco Addiction

  • Exclusion Criteria

    • Pregnancy and lactation (or those wanting to conceive)

    • Chronic skin conditions

    • Use of other tobacco products

    • Use of tobacco cessation product w/in last 30 days

    • Other drug or alcohol dependence

    • Mania, psychosis, or acute depression

      • Those taking pyschotropic meds were not an excluded


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Participant Stats Treatment of Adolescent Tobacco Addiction

  • Avg age: 15

  • 72.5% white

  • 70% female

  • Avg of 18.8 Cigarettes/Day

  • FTND of 7


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Fagerstr Treatment of Adolescent Tobacco AddictionÖm Test of Nicotine Dependence


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Fagerstr Treatment of Adolescent Tobacco AddictionÖm Test of Nicotine Dependence


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Fagerstr Treatment of Adolescent Tobacco AddictionÖm Test of Nicotine Dependence

  • Dependence Level

    • 0-2 Very low dependence

    • 3-4 Low dependence

    • 5 Medium dependence

    • 6-7 High dependence

    • 8-10 Very High dependence


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Methods Treatment of Adolescent Tobacco Addiction

  • Initial visits

    • FagerstrÖm Questionnaire

    • Expired CO level obtained

    • Baseline nicotine and thiocyanate levels drawn via blood and saliva

    • Pregnancy test for all females

  • Target quit date 1 week after visits


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Methods Treatment of Adolescent Tobacco Addiction

  • 12 week study with weekly follow-ups

  • At each visit

    • Exhaled CO measured

    • Saliva levels of cotinine and thiocyanate obtained

    • Used and unused patches collected, new ones dispensed

  • 6 month post study follow up


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Methods Treatment of Adolescent Tobacco Addiction

  • Double blinded, randomized study

  • Three arms

    • Nicotine Patch with placebo gum

    • Nicotine Gum with placebo patch

    • Placebo Patch and placebo Gum

  • All received Cognitive & behavior group therapy


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Attrition Treatment of Adolescent Tobacco Addiction

  • Patch 52.9% completed study

  • Gum 41.3%

  • Placebo 40%


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Overall Results Treatment of Adolescent Tobacco Addiction

  • Patch was significantly more effective than placebo with prolonged abstinence.

  • Level of expired CO and saliva levels unchanged.

    • Possibly from compensatory smoking (deeper inhalation)?

  • Change in cigarettes per day decreased by an average of 80% across all three arms


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Safety Treatment of Adolescent Tobacco Addiction

  • Found to be safe

    • 745 reported side effects

    • Most common side effects: pruritis (130), erythema (111) , headache (86) and fatigue (67)

  • Side effects comparable to adult trials

  • Felt by authors to not have affected retention in study


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Results: Efficacy Treatment of Adolescent Tobacco Addiction

  • Abstinence rates at 3 months:

    • Patch: (17.7%)

    • Gum: (6.5%)

    • Placebo: (2.5%)


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Abstinence over time Treatment of Adolescent Tobacco Addiction


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Are the results valid? Treatment of Adolescent Tobacco Addiction

  • Double blind

  • Randomized

  • All participants accounted for with completed follow up


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Conclusions Treatment of Adolescent Tobacco Addiction

  • Nicotine patch therapy combined with cognitive-behavioral intervention was safe and effective when compared to placebo for treatment


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Study limitations Treatment of Adolescent Tobacco Addiction

  • Small sample size; only 120 enrolled from 1347 who were originally interested

    • Inclusion criteria may have been too strict

      • Resulted in a study with no sociodemographic difference

        • 70 % white

        • 70% female


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Study limitations Treatment of Adolescent Tobacco Addiction

  • Psychiatric comorbidities may have contributed to high drop out rate

    • 75% had at least 1 psychiatric Dx (64% patch, 75% gum, and 85% placebo)

      • Oppositional Defiant Disorder (40%)

      • Conduct Disorder (15%)

      • ADHD (7%)

    • ~25% taking psychotropic medications


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Limitations Treatment of Adolescent Tobacco Addiction

  • “Teens might have reported their cigarette consumption inaccurately…”

  • High drop out rate from gum arm not from adverse effects but rather taste


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How does this effect our practice? Treatment of Adolescent Tobacco Addiction

  • All studies show that the success rate of smoking cessation by any means (Patch, gum, Bupropion) remains poor

  • Studies with the best results show that the medicinal treatment was accompanied by behavioral intervention as done in this study

    • Confirmed by reduction of 80% CPD in all three arms

    • Swiss study showed reduction of 5 CPD had high chance of abstinence 3 years out


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PCM interventions Treatment of Adolescent Tobacco Addiction

  • 5 A’s

    • Ask

    • Advise

    • Assess

    • Assist

    • Arrange


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Bad breath, stinky clothes Treatment of Adolescent Tobacco Addiction

Implications on health in long term

Money spent that could be used to buy other things

Advise


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Assess Treatment of Adolescent Tobacco Addiction

  • Willingness to quit?

  • Have any attempts been made lately?

  • What has been attempted in past?


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Assist Treatment of Adolescent Tobacco Addiction

  • Help set a quit date

  • Help set up supportive environment of family and friends

  • Provide anticipation of side effects


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Arrange Treatment of Adolescent Tobacco Addiction

  • Arrange follow ups

  • Positive reinforcement


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For best results… Treatment of Adolescent Tobacco Addiction

  • Primary prevention

  • School/Office interventions

  • Behavior/group therapy

  • Patience

  • Persistence


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