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 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

Fagerstr Ö m 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 Fagerstr Ö m 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