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
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.
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
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
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
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
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
Advise Bad breath, stinky
clothes Implications on health
in long term Money spent that could
be used to buy other things
Assist Help set a quit date Help set up supportive environment of family
and friends Provide anticipation of side effects