carcinogen exposure part 1

7/27/2019 Carcinogen Exposure Part 1

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Carcinogen Exposure and Risk Reduction AmongSmokers Randomized to a Tobacco Potentially

Reduced-Exposure Product (PREP) or MedicinalNicotine: A Feasibility Study

J ennifer Guzi, RN, BSN, MSNc, FNPcAndrea Prados, RN, BSN, MPH, MSNc, FNPc

Georgetown UniversitySchool of Nursing and Health Sciences


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Acknowledgments

American Cancer Societys Institutional Research Grant

University of Minnesota QUEST Study Research Team- PI,Dorothy Hatsukami, PhD & Project Coordinator, J oni J ensen,MS

Georgetowns QUEST Study Research Team{ J anie Heath, PhD, APRN-BC

{ Peter Shields, MD

{ Stephanie Spernak, PhD

{ Colleen Lynch, MS

{ Zumei Feng, MD

{ J erry Taddeo, BS, MS, MTASCP

{ FNP Student Researchers: J ennifer Guzi, Andrea Prados, Colleen Pierce, MorganeSwift

{ NHS Student Interns: Warren Sizemore, Enela Zyka


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State-Specific Prevalence of Smoking

among Adults, 2004

Centers for Disease Control and Prevention. (2005). MMWR 54:11241127.

Utah

10.5%

Kentucky

27.6%

Virginia

20.8%

Maryland

20.2%

DC

20.8%

44.5 Million Adult Smokers


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Compounds in Tobacco

SmokeAn Estimated 4,800 Compounds in

Tobacco SmokeGases (~500 isolated) Particles (~3,500 isolated)

CarbonMonoxide

HydrogenCyanide

Ammonia

BenzeneFormaldehyde

NicotineNitrosamines

LeadCadmium

Polonium-210


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Annual U.S. Deaths Attributable to

Smoking, 19972001

32%

Centers for Disease Control and Prevention. (2005). MMWR 54:625628.

28%

23%

9%

8%


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Background

Vector Tobacco Companymarkets a 3-step approach tobecoming smoke free withQuest Cigarettes

Quest 1 = Low nicotine(0.6mg)

Quest 2 = Extra low nicotine

(0.3mg) Quest 3 = Nicotine- free

(0.05mg)


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Background

No evidence currently addresses theefficacy of using Quest Cigarettes

No evidence currently addresses the

tobacco toxin uptake from Quest Cigarettes No evidence currently exists for cessation

outcomes when comparing Quest Cigarettesand FDA approved medicinal nicotineamong smokers


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Quest Study Enrollment

Summer Semester2005: n=20

Fall Semester

2005: n=20

Spring Semester

2005: n=20


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Research Purpose

A pilot study to demonstrate capability tocarry out a large clinical trial to study thehealth and behavioral effects of potentialreduced exposure products (PREPS) anda smoking cessation intervention. Data(to be pooled with similar data from theUniversity of MN) will support RO1

application and other fundingmechanisms.


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Hypothesis #1

Differences incessation outcomeswill be observed withindividuals randomized

to receive nicotine-free Quest cigarettes,extra-low Quest

cigarettes andCommit lozenges.


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Hypothesis #2

Differences in healtheffects will beobserved with

individuals randomizedto receive nicotine-free Quest cigarettes,

extra-low Questcigarettes andCommit lozenges.


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Research Design

12 week, randomized clinical trial{ Group 1 = Quest 0.05mg nicotine &

weekly counseling

{ Group 2 = Quest 0.3mg nicotine &weekly counseling

{ Group 3 = Commit 2mg lozenge &weekly counseling


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Research Method

Sample

Recruited 60 subjectsover 12 months

{ Males and Females

{ Age = 18 70

{ Smoking between 10 40 cigs/day for past yr

{ Smoking light, ultra-light, and mentholcigarettes


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Research Method

Procedure

{ 2 week orientation/evaluation whilesmoking own cigarettes

{ Treatment timeline = on product (Quest#2 or Quest #3 or Commit) x 6 weeks

{ Cessation timeline = off product x 6

weeks{ 12 visits include behavioral measures,

biological measures, product, &

counseling


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Research Measures Biomarkers for tobacco

exposure{ Blood & urine cotinine{ Urinary anatabine{ Alveolar carbon monoxide

Biomarkers for carcinogenexposure{ NNAL & NNAL-glucuronides{ 1-hydroxypryrene{ Muconic acid{ Mercapturic acids of acrolein

& butadiene{ Phenanthren tetrol{ Urine mutagenicity{ NNN{ 1-HOP

Biomarkers for CVdisease{ Lipoproteins (total

cholesterol, HDL & LDL){ Triglycerides, apoprotein

A-1 & B concentrations{ C-reactive protein

{ Fibrinogen{ WBC{ Vital signs & weight

Biomarkers for pulmonaryfunction/lung disease

{ FEV1, FVC, PEF, FEV%{ (PAH)-DNA adducts &

chromosome aberrations{ Self-reported respiratory

sx{ CO readings


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Research Measures Genotyping to assess

treatment response

{ CYP2A6{ CYP2B6{ SLC6 A3{ DRD2{ Dopamine transporter{ Dopamine D2 & D4

receptor

{ Dopamine B hydroxylase{ Catechol

methyltransferase{ Monamine oxidase

Topography

Behavioral measures

{ Medical history, respiratorysx

{ Demographics{

Smoking intake & diaries{ Fagerstromquestionnaire{ Cigarette Dependence Scale{ Reasons for smoking{ WISDM{ Withdrawals symptoms{ Intention to quit-ladder{ Motivation & self-efficacy{ PANAS

{ Q-DIS{ CES- Depression


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Protocol Baseline 1 =

{ Check in:questionnaires{ Lab: VS, WT, CO,

FEV1, Serum, Urine,Mouthwash, Butt Bags

{ Counseling: reviewdiaries, distributeproduct

{ Check out: review

completion ofquestionnaires,schedule next appt,payment, completechecklist

Baseline 2 =

{ Check in:questionnaires{ Lab: VS, WT, CO,

Serum, Urine,Mouthwash, Butt Bags,

Typography{ Counseling: review

diaries, distributeproduct

{

Check out: reviewcompletion ofquestionnaires,schedule next appt,payment, complete

checklist


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Protocol Visit 1 = tx week

{ Check in questionnaires{

Lab: VS, WT, CO{ Counseling{ Check out process

Visit 2 = tx week{ Check in questionnaires{ Lab: VS, WT, CO, FEV1,

Typography, Serum, Urine,Mouthwash, Butt Bags,Typography

{ Counseling{ Check out process

Visit 3 = tx week{ Check in questionnaires{ Lab: VS, WT, CO, FEV1


Visit 4 = tx week{ Check in questionnaires{

Lab: VS, WT, CO{ Counseling{ Check out process

Visit 5 = tx week{ Check in questionnaires{ Lab: VS, WT, CO, FEV1{ Counseling{ Check out process

Visit 6 = tx week

{ Check in questionnaires{ Lab: VS, WT, CO, FEV1,

Typography, Serum, Urine,Mouthwash, Quest = ButtBags & Typography



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Protocol Visit 7 = off product week

{ Check in questionnaires{ Lab: VS, WT, CO{ Counseling{ Check out process

Visit 8 = off product

{ Check in questionnaires

{ Lab: VS, WT, CO{ Counseling{ Check out process

Visit 9 = NO VISIT

Visit 10 = off product week

{ Check in questionnaires{ Lab: VS, WT, CO{ Counseling{ Check out process

Visit 11 = NO VISIT

Visit 12 = off product week

{ FINAL Check inquestionnaires

{ FINAL Lab: VS, WT, CO,FEV1, Serum, Urine,Mouthwash

{ FINAL Counseling{ FINAL Check out process

4 week follow up to evaluatecessation status


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Lessons Learned

The importance ofmethodicalcollection anddocumentation of

data The outcome of the

study is dependantupon the reliabilityand compliance ofthe subjects


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Lessons Learned Our background in

nursing provided astrong foundation toserve as smokingcessation counselors

The value of receivingtobacco cessationeducation PRIOR tostarting study

The challenges ofstaying on protocol orscriptas tobaccocessation counselors


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Questions?

Part I of the FAB 4FNP QUEST Study

J ourney:

{ Purpose?{ Design?

{ Method?

THANK YOU

FNPs Committed to Helping Patients Quit: Call 1-800 Quit Now

carcinogen exposure part 1

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