Smoking and Tobacco Related Issues Networking Group (String) AAC R Treating Tobacco Use and...

Smoking and Tobacco Related Issues Networking Group (String)Smoking and Tobacco Related Issues Networking Group (String)

AAAA CCRR

Treating Tobacco Use and Treating Tobacco Use and Dependence GuidelinesDependence Guidelines

Scott Marlow RRTScott Marlow RRTPulmonary Rehabilitation CoordinatorPulmonary Rehabilitation Coordinator

Cleveland Clinic FoundationCleveland Clinic Foundation


AAAA CCRR Treating Tobacco Use and Treating Tobacco Use and Dependence Guidelines:ObjectivesDependence Guidelines:Objectives

To understand current guideline summaries and To understand current guideline summaries and there application for tobacco cessationthere application for tobacco cessation

To be able to identify national reports that can To be able to identify national reports that can provide additional resources for tobacco cessation provide additional resources for tobacco cessation

To provide information regarding where current To provide information regarding where current research is being conductedresearch is being conducted


AAAA CCRR Treating Tobacco Use and Treating Tobacco Use and Dependence GuidelinesDependence Guidelines

Guideline summariesGuideline summaries

National reports National reports

ResearchResearch


AAAA CCRR Why is a summary necessary?Why is a summary necessary?

Resource for quick informationResource for quick information

Too much informationToo much information

Google search of Tobacco Cessation Google search of Tobacco Cessation Guidelines = 589,000 !!Guidelines = 589,000 !!

Tobacco addiction remains highTobacco addiction remains high

Increasing world wide burdenIncreasing world wide burden

Increased health care cost Increased health care cost


AAAA CCRR Why is a summary necessary?Why is a summary necessary?

0

200

400

600

800

1000

1200

2000 2001 2002 2003 2004

Medline: Smoking cessation articles seach

Number of smokingcessation articles


AAAA CCRR EvidenceEvidence

The ineffective approachThe ineffective approach

Look it up in a textbookLook it up in a textbook

The inefficient approachThe inefficient approach

Do a Pubmed search / Internet search. Do a Pubmed search / Internet search. Tobacco cessation search 8,707 articles!Tobacco cessation search 8,707 articles!

The efficient approachThe efficient approach

Evidence-based clinical practice Evidence-based clinical practice guidelinesguidelines


AAAA CCRR EvidenceEvidence

United States Department of United States Department of Health and Human Services Health and Human Services (USDHHS) Clinical Practice (USDHHS) Clinical Practice Guidelines on Treating Guidelines on Treating Tobacco Use and Tobacco Use and DependenceDependence

Updated 2000Updated 2000

Original 1996Original 1996

6000 total articles6000 total articles

5 month abstinence5 month abstinence

Cochrane collaborationCochrane collaboration

Updated regularly Updated regularly (2002)(2002)

6-12 month abstinence6-12 month abstinence

Randomized trialsRandomized trials

Analysis of subgroupsAnalysis of subgroups

Provide details of Provide details of methodsmethods


AAAA CCRRStrength of evidence Strength of evidence

classificationclassificationCriteriaCriteria

Strength of evidence = A Multiple will-designed randomized clinical trial, directly relevant to the recommendation, yielded a consistent pattern of findings.

Strength of evidence =B Some evidence from randomized clinical trials supported the recommendation, but the scientific support was not optimal. For instance, few randomized trials existed, the trials that did exist were somewhat inconsistent, or the trials were not directly relevant to the recommendation..

Strength of evidence =C Reserved for important clinical situations where the panel achieved consensus on the recommendation in the absence of relevant randomized controlled trials.

Summary of Strength of Evidence for Recommendations

Fiore, MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service.June 2000




Behavioral interventionsBehavioral interventions

PharmacotherapyPharmacotherapy

Combination therapyCombination therapy


AAAA CCRR Behavioral InterventionsBehavioral Interventions

All work to varying degreesAll work to varying degrees

Physician advicePhysician advice

Nurse or nonphysician adviceNurse or nonphysician advice

Individual counselingIndividual counseling

Group counselingGroup counseling

Telephone counselingTelephone counseling

Self-helpSelf-help


AAAA CCRR Behavioral InterventionsBehavioral Interventions

Intervention Improvement incessation overcontrols

Physician advice 2-3%

Non-physician advice 1-5.6%

Individual 4-6%%

Group counseling 3-10.1%

Self help 1-1.5%

Telephone counseling 2.3-2.4%Sources. The Cochrane Database of Systemic Reviews et al, The Cochrane Library. 2001-2003 . And [1] Fiore, MC, Bailey WC, CohenSJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and HumanServices. Public Health Service. June 2000


AAAA CCRR Minimal Intervention Minimal Intervention The 5 A’sThe 5 A’s

AskAsk

AdviseAdvise

AssessAssess

AssistAssist

ArrangeArrange

Fiore, MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical PracticeFiore, MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice

Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service.Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service.

June 2000June 2000


AAAA CCRR Enhancing Motivation to QuitEnhancing Motivation to QuitThe 5 R’s The 5 R’s

RelevanceRelevance

RiskRisk

RewardsRewards

RoadblocksRoadblocks

RepetitionRepetition

Fiore, MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical PracticeFiore, MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice

Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service.Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service.

June 2000June 2000


AAAA CCRR Behavioral InterventionBehavioral Intervention

Dose responseDose response

Intensity of counseling, time per Intensity of counseling, time per sessionsession

Total contact timeTotal contact time

Number of sessionsNumber of sessions

Number of formatsNumber of formats

Numbers of various cliniciansNumbers of various clinicians


AAAA CCRR

Table 12. Estimated abstinence rates for various intensity levels of person-to-person contact (N=43 studies)

0

5

10

15

20

25

30

No minutes 1-3 minutes 4-30 minutes 31-90 minutes

Level of contact

Est

imat

d ab

stin

ence

rate

(%

)

Adapted from Fiore, MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. June 2000

Behavioral InterventionBehavioral InterventionIntensity of Person-to-Person ContactIntensity of Person-to-Person Contact


AAAA CCRR


Table 14. Estimated abstinence rates for numer of person-to-person treatment sessions (N=43 studies)

0

5

10

15

20

25

30

0-1 session 2-3 sessions 4-8 sessions >8 sessions

Number of sessions

Est

imat

d ab

stin

ence

rate

(%)

Behavioral InterventionBehavioral InterventionNumber of SessionsNumber of Sessions


AAAA CCRR

Table 11. Meta-analysis: estimated abstinence rates for number of formats* (n=54)

0

5

10

15

20

25

No format One format Two formats Three or fourformats

Number of formats

Estim

ate

d A

bstine

nce

ra

te %

* Formats included self-help, proactive telephone counseling, group or individual counseling


Behavioral InterventionBehavioral InterventionNumber of FormatsNumber of Formats


AAAA CCRR

Table 11. Meta-analysis: Interventions Delivered by Various Numbers of Clinicians

0

5

10

15

20

25

No clinician One clinician type Two clinician types Three or moreclinician types

Number of Clinician Types

Est

imat

ed A

bstin

ence

rat

e %


Behavioral InterventionBehavioral InterventionNumber of CliniciansNumber of Clinicians


AAAA CCRR


Table 13. Meta-analysis: Estimated abstinence rates for total amount of contact time (n=35 studies)

0

5

10

15

20

25

30

No minutes 1-3 minutes 4-30minutes

31-90minutes

91-300minutes

< 300minutes

Total contact time

Est

imat

ed

abst

inen

ce r

ate

%

Behavioral InterventionBehavioral InterventionTotal Minutes of Contact TimeTotal Minutes of Contact Time


AAAA CCRR Pharmacology Pharmacology All effective to varying degreesAll effective to varying degrees

Five first-line tobacco cessation medicines Five first-line tobacco cessation medicines

Nicotine gum (polacrilex) Nicotine gum (polacrilex)

Nicotine patchNicotine patch

Nicotine nasal sprayNicotine nasal spray

Nicotine inhaler Nicotine inhaler

BupropionBupropion

Two second-line tobacco cessation medicinesTwo second-line tobacco cessation medicines

ClonidineClonidine

NortriptylineNortriptylineFiore, MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. June 2000


AAAA CCRR First Line PharmacologyFirst Line Pharmacology


Nicotine Gum 2 mg or 4 mg 6.6-8%

Nicotine patch 7-21 mg 6-7.7%

Nicotine Nasal Spray 12-16.6%

Nicotine Inhaler 8-12.3%

Bupropion 10-13.2%

Source Silagy C, Lancaster T, Stead L, Mant D, Fowler G. Nicotine replacement therapy for smoking cessation .The Cochrane Database of Systemic Reviews, The Cochrane Library. Vol 1 2003. Hughes JR, Stead LF,Lancaster T. Antidepressants for smoking cessation . The Cochrane Database of Systemic Reviews, TheCochrane Library. Vol 1 2003And [1] Fiore, MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use andDependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. PublicHealth Service. June 2000


AAAA CCRR First Line PharmacologyFirst Line Pharmacology

Highly addictedHighly addicted

Greater than 20 cigarettes/dayGreater than 20 cigarettes/day

First cigarette within the 30 minutes First cigarette within the 30 minutes of wakingof waking

Use increase dose of NRTUse increase dose of NRT

4mg gum or lozenge versus 2mg4mg gum or lozenge versus 2mg

Fiore, MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. June 2000


AAAA CCRR Second Line PharmacologySecond Line Pharmacology

Two second-line tobacco cessation medicinesTwo second-line tobacco cessation medicines

ClonidineClonidine

NortriptylineNortriptyline

Recommended case by caseRecommended case by case

Not approved by Food and Drug Administration Not approved by Food and Drug Administration (FDA) for tobacco dependence(FDA) for tobacco dependence

More potential side effects than first line More potential side effects than first line pharmacologypharmacology

Fiore, MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. June 2000


AAAA CCRR Second Line PharmacologySecond Line Pharmacology


Clonidine 11-11.7%

Nortriptyline 12-18.4%

Sources: Hughes JR, Stead LF, Lancaster T. Antidepressants for smoking cessation. The Cochrane Databaseof Systemic Reviews, The Cochrane Library.2003 (2). Gourlay SG, Stead LF, Benowitz NL. Clonidine forsmoking cessation. The Cochrane Database of Systemic Reviews, The Cochrane Library. 2000 (2). And Fiore,MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence. Clinical Practice Guideline. Rockville,MD: U.S. Department of Health and Human Services. Public Health Service. June 2000


AAAA CCRR Alternative: Not endorsed at this Alternative: Not endorsed at this time but may prove effective time but may prove effective

BehavioralBehavioral

HypnotherapyHypnotherapy

Aversive Aversive therapytherapy

AcupunctureAcupuncture

ExerciseExercise

PharmacologicalPharmacological Lobeline Nicotine agonistLobeline Nicotine agonist Anxiolytics Anxiolytics

DiazepamDiazepam MeproprobomateMeproprobomate Metoprolol Metoprolol OxprenololOxprenolol

Mecamaylamine Mecamaylamine Nicotine agonistNicotine agonist


AAAA CCRR Combined TherapiesCombined Therapies

More than one NRT for highly addicted or failed More than one NRT for highly addicted or failed previous NRT cessation trials recommended by previous NRT cessation trials recommended by USDSS Clinical Practice Guidelines.USDSS Clinical Practice Guidelines.

3 pooled studies3 pooled studies Improved cessation by 11% over Improved cessation by 11% over

monotherapymonotherapy

More restraint urged by Cochrane DatabaseMore restraint urged by Cochrane Database



Combined behavioral and interventionalCombined behavioral and interventional Lung Health Study Lung Health Study

10 Centers enrolled 5887 mild COPD 10 Centers enrolled 5887 mild COPD patients who smokepatients who smoke

Randomized to 3 groupsRandomized to 3 groups Usual care (1964 control vs 3923 Usual care (1964 control vs 3923

intervention)intervention) Smoking cessation plus inhaled Smoking cessation plus inhaled

ipratropiumipratropium Smoking cessation plus inhaled Smoking cessation plus inhaled

placeboplacebo



Combined behavioral and interventionalCombined behavioral and interventional Lung Health Study Lung Health Study

Smoking cessation involvedSmoking cessation involved Intensive 12 session Intensive 12 session

intervention intervention Individual interventionIndividual intervention Nicotine polacrilex (gum)Nicotine polacrilex (gum)


AAAA CCRR Lung Health Study ResultsLung Health Study Results

11 year abstinence 11 year abstinence

22% intervention vs. 6% control 22% intervention vs. 6% control 11

11 year FEV1 decline per year11 year FEV1 decline per year

non smokers vs smokers non smokers vs smokers 22

Men 30cc vs 66ccMen 30cc vs 66cc

Women 21cc vs 54cc Women 21cc vs 54cc

Nicotine polocrilex is safe and unrelated to Nicotine polocrilex is safe and unrelated to cardiovascular illness cardiovascular illness 33

1.Murray et al, Persistence of the effect of the Lung Health Study smoking intervention over eleven years. Prev Med. 2002, Oct; 35(4). 2. Anthonisen etl al. Smoking and lung function of Lung Health Study participants after 11 years. Am j Resp Crit Care Med. 2002 Sep 1; 166 (5)3 Murray et al, Safety of nicotine polacrilex gum used by 3,094 participants in the Lung Health Study. Chest. 1996 Feb. 109(2)




National reportsNational reports

ResearchResearch


AAAA CCRR National Reports and OrganizationsNational Reports and Organizations

National Institutes of Health (NIH)National Institutes of Health (NIH) http://health.nih.gov http://health.nih.gov

U.S. Surgeon GeneralU.S. Surgeon Generalhttp://www.surgeongeneral.gov/tobacco/dhttp://www.surgeongeneral.gov/tobacco/default.htmefault.htm

National Insitute on Drug Abuse (NIDA)National Insitute on Drug Abuse (NIDA)http://www.nida.nih.govhttp://www.nida.nih.gov


AAAA CCRR National Reports and OrganizationsNational Reports and Organizations

National Cancer Institute (NCI)National Cancer Institute (NCI) http://www.nci.nih.govhttp://www.nci.nih.gov

National Heart, Lung and Blood Institue National Heart, Lung and Blood Institue (NHLBI)(NHLBI) http://www.nhlbi.nih.gov/index.htmhttp://www.nhlbi.nih.gov/index.htm

American Lung Association American Lung Association http://www.lungusa.orghttp://www.lungusa.org

Smokefree.GovSmokefree.Gov




National reports National reports

ResearchResearch


AAAA CCRR ResearchResearch

Robert Wood Johnson Robert Wood Johnson Foundationhttp://www.rwjf.orgFoundationhttp://www.rwjf.org

National Cancer Institute: National Cancer Institute: http://dccps.nci.nih.gov/tcrb/http://dccps.nci.nih.gov/tcrb/

Transdisciplinary Tobacco Use Research Transdisciplinary Tobacco Use Research Center: www.tturc Center: www.tturc


AAAA CCRR Treating Tobacco Use and Treating Tobacco Use and Dependence Guidelines:ConclusionDependence Guidelines:Conclusion

Reviewed current guideline summaries for Reviewed current guideline summaries for tobacco cessationtobacco cessation

Identified national reports that can provide Identified national reports that can provide additional resources for tobacco cessation additional resources for tobacco cessation

Provided information regarding where current Provided information regarding where current research is being conductedresearch is being conducted

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