Safety and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Addiction

1. Safety and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Addiction Tony Nguyen, PGY2

2. 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

3. 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.

4. His only question: • Does nicotine replacement therapy work, and how safe is it?

5. 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

6. 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.

7. 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

8. 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.

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. Studies • J. Addiction 2005 – JW May et al… • 30% of those attempting NRT had quit • 39% of those NOT attempting NRT had quit

16. Back to the original question… • Is Nicotine replacement safe and efficacious for teens?

17. Safety and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Addiction • Participants • Methods • Results • Conclusions

18. Participants • Inner city Baltimore • Outreach and recruitment over 4 year via media, schools, and churches • Eligibility based on history, physical exam, and laboratory screening

19. 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

20. 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

21. Participant Stats • Avg age: 15 • 72.5% white • 70% female • Avg of 18.8 Cigarettes/Day • FTND of 7

22. FagerstrÖm Test of Nicotine Dependence

23. FagerstrÖm Test of Nicotine Dependence

24. 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

25. 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

26. 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

27. 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

30. Attrition • Patch 52.9% completed study • Gum 41.3% • Placebo 40%

31. 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

32. 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

33. Results: Efficacy • Abstinence rates at 3 months: • Patch: (17.7%) • Gum: (6.5%) • Placebo: (2.5%)

34. Abstinence over time

35. Are the results valid? • Double blind • Randomized • All participants accounted for with completed follow up

36. Conclusions • Nicotine patch therapy combined with cognitive-behavioral intervention was safe and effective when compared to placebo for treatment

37. 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

38. 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

39. Limitations • “Teens might have reported their cigarette consumption inaccurately…” • High drop out rate from gum arm not from adverse effects but rather taste

40. 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

41. Best way to stop smoking is prevention from smoking

42. PCM interventions • 5 A’s • Ask • Advise • Assess • Assist • Arrange

43. Bad breath, stinky clothes Implications on health in long term Money spent that could be used to buy other things Advise

44. Assess • Willingness to quit? • Have any attempts been made lately? • What has been attempted in past?

45. Assist • Help set a quit date • Help set up supportive environment of family and friends • Provide anticipation of side effects

46. Arrange • Arrange follow ups • Positive reinforcement

47. For best results… • Primary prevention • School/Office interventions • Behavior/group therapy • Patience • Persistence