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

FagerstrÖm Test of Nicotine Dependence

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%)

Abstinence over time

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

Best way to stop smoking is prevention from smoking

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

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