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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
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
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: • Does nicotine replacement therapy work, and how safe is it?
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 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* • 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 • 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.
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 • 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 • 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
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
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
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
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… • Is Nicotine replacement safe and efficacious for teens?
Safety and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Addiction • Participants • Methods • Results • Conclusions
Participants • Inner city Baltimore • Outreach and recruitment over 4 year via media, schools, and churches • Eligibility based on history, physical exam, and laboratory screening
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
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 • Avg age: 15 • 72.5% white • 70% female • Avg of 18.8 Cigarettes/Day • FTND of 7
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 • 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
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
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 • Patch 52.9% completed study • Gum 41.3% • Placebo 40%
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 • 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 • Abstinence rates at 3 months: • Patch: (17.7%) • Gum: (6.5%) • Placebo: (2.5%)
Are the results valid? • Double blind • Randomized • All participants accounted for with completed follow up
Conclusions • Nicotine patch therapy combined with cognitive-behavioral intervention was safe and effective when compared to placebo for treatment
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 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 • “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? • 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 • 5 A’s • Ask • Advise • Assess • Assist • Arrange
Bad breath, stinky clothes Implications on health in long term Money spent that could be used to buy other things Advise
Assess • Willingness to quit? • Have any attempts been made lately? • What has been attempted in past?
Assist • Help set a quit date • Help set up supportive environment of family and friends • Provide anticipation of side effects
Arrange • Arrange follow ups • Positive reinforcement
For best results… • Primary prevention • School/Office interventions • Behavior/group therapy • Patience • Persistence