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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


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safety and efficacy of the nicotine patch and gum for the treatment of adolescent tobacco addiction
Safety and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Addiction

Tony Nguyen, PGY2

slide2
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
slide3
Home: Parents, 2 younger siblings
  • 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.
his only question
His only question:
  • Does nicotine replacement therapy work, and how safe is it?
smoking fast facts
Smoking Fast Facts
  • 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
smoking fast facts6
Smoking Fast Facts
  • 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.
more smoking fast facts
More Smoking Fast Facts*
  • 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

teenage smoking fast facts
Teenage Smoking Fast Facts
  • 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.
slide9
86.8% of students who smoke nicotine at least once daily are chemically dependent under DSM IV mental health standards
  • Journal of Pediatric Psychology June, 2005
smoking cessation studies
Smoking cessation studies
  • 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
studies
Studies
  • 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
studies12
Studies
  • 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
studies13
Studies
  • 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
studies14
Studies
  • 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
studies15
Studies
  • J. Addiction 2005 – JW May et al…
    • 30% of those attempting NRT had quit
    • 39% of those NOT attempting NRT had quit
back to the original question
Back to the original question…
  • Is Nicotine replacement safe and efficacious for teens?
safety and efficacy of the nicotine patch and gum for the treatment of adolescent tobacco addiction17
Safety and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Addiction
  • Participants
  • Methods
  • Results
  • Conclusions
participants
Participants
  • Inner city Baltimore
  • Outreach and recruitment over 4 year via media, schools, and churches
  • Eligibility based on history, physical exam, and laboratory screening
participants19
Participants
  • 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
participants20
Participants
  • 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
participant stats
Participant Stats
  • Avg age: 15
  • 72.5% white
  • 70% female
  • Avg of 18.8 Cigarettes/Day
  • FTND of 7
fagerstr m test of nicotine dependence24
FagerstrÖm 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
methods
Methods
  • 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
methods26
Methods
  • 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
methods27
Methods
  • 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
attrition
Attrition
  • Patch 52.9% completed study
  • Gum 41.3%
  • Placebo 40%
overall results
Overall Results
  • 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
safety
Safety
  • 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
results efficacy
Results: Efficacy
  • Abstinence rates at 3 months:
    • Patch: (17.7%)
    • Gum: (6.5%)
    • Placebo: (2.5%)
are the results valid
Are the results valid?
  • Double blind
  • Randomized
  • All participants accounted for with completed follow up
conclusions
Conclusions
  • Nicotine patch therapy combined with cognitive-behavioral intervention was safe and effective when compared to placebo for treatment
study limitations
Study limitations
  • 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
study limitations38
Study limitations
  • 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
limitations
Limitations
  • “Teens might have reported their cigarette consumption inaccurately…”
  • High drop out rate from gum arm not from adverse effects but rather taste
how does this effect our practice
How does this effect our practice?
  • 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
pcm interventions
PCM interventions
  • 5 A’s
    • Ask
    • Advise
    • Assess
    • Assist
    • Arrange
advise
Bad breath, stinky clothes

Implications on health in long term

Money spent that could be used to buy other things

Advise
assess
Assess
  • Willingness to quit?
  • Have any attempts been made lately?
  • What has been attempted in past?
assist
Assist
  • Help set a quit date
  • Help set up supportive environment of family and friends
  • Provide anticipation of side effects
arrange
Arrange
  • Arrange follow ups
  • Positive reinforcement
for best results
For best results…
  • Primary prevention
  • School/Office interventions
  • Behavior/group therapy
  • Patience
  • Persistence