1

Current Evidence-Based Cessation Treatments:

Efficacy and Critical Ingredients

Saul Shiffman

2

Outcome of Smoking Cessation without Treatment

47% report trying to quit annually

13% of unaided quit efforts don’t last 24 h

Sustained unaided quit rate <3%

Behavioral treatment

Pharmacologic treatment

4

Behavioral Treatment

Aimed at assisting behavior change Practical psycho-educational approach Based on cognitive-behavioral treatment

principles “Multi-component” mix dominates

Few/no “brand-name” differentiated treatment approaches

Little/no content innovation in 20 years

5

Active Ingredients in Behavioral Programs

Information

Motivation enhancement

Encouragement

Support

Planning & problem-solving

Tips & techniques

Medication support

Process orientation

Structure Conceptual

Temporal

A specific, step-by-step, pathway to quitting

Contact, engagement, caring

Lifestyle change

6

Effectiveness of Behavioral Treatment Components

0

5

10

15

20

25

Est

. q

uit

rat

e

No contact

Aversive smoking*

Problem solving*

External support*

Support in trtmt*

Mood/stress mgmt

Weight/diet

Contracting

Relaxation

Source: AHRQ analysis: 2000

* Significantly better than nothing

Guess which treatment is no longer in current use

7

More is Better

0

5

10

15

20

25

30

Est

. q

uit

rat

e

< 2 wks

2-4 wks

4-8 wks

> 8 wks

Source: AHRQ analysis: 2000

8

Developments in Behavioral Treatment

Little/no content innovation Innovations in delivery modality &

disseminationChannelsMediaProvidersPackagingDuration

9

The Old & New Models of Behavioral Treatment

Old way New way

ApproachApproach Cognitive-behavioral

Cognitive-behavioral

MediumMedium Face-2-face Phone, web

Delivery modelDelivery model Central De-centralized

ProviderProvider Semi-Pro Para-pro, computer

ScriptingScripting Ad-lib Scripted

IntensityIntensity High Low-Medium

MedicationMedication Negative Integrate

10

Some Low-Intensity, Convenient Forms Are Ineffective

0

2

4

6

8

10

12

Est

. q

uit

rat

e No self-help

Hotline*

Tapes

Referal

Booklets

Source: AHRQ analysis: 2000

11

Effectiveness Rises with Intensity

0

2

4

6

8

10

12

14

16

18

Est

. q

uit

rat

e No Tx

Self-help

Proactive phone*

Group Counseling*

Indiv. Counseling*

Source: AHRQ analysis: 2000

12

Targeting to Groups

By gender, ethnicity, age, disease, etc, etc

No evidence they require different approaches

Targeted materials may be more appealing

Situations that affect the challenge & need may need different approach e.g., pregnancy, acute abstinence in hospital

13

Tailoring to Individuals

One size does not fit all Assess user Tailor content, emphasis,

sequence to individual characteristics and needs

Model what a counselor woulddo

Greater utilization, satisfaction Improved efficacy

14

Behavioral treatment

Pharmacologic treatment

15

Pharmacological Treatment

Meant to address dependence-related symptoms

Nicotine Replacement Therapy (NRT) Patch Gum Lozenge Puffer Nasal spray

Bupropion New compounds, approaches coming

(Frank Vocci)

OTC

16

All Medications Effective;About Equally Effective

0 5 10 15 20 25 30 35

Nicotine gum

Nicotine patch

Nicotine puffer

Nicotine nasal spray

Bupropion

Est. quit rate

Placebo

Active

Source: AHRQ analysis: 2000

Studies vary in populations, behavioral intervention, and length of follow-up

17

Combining Medications Enhances Efficacy

0

5

10

15

20

25

30

35

Est

. q

uit

rat

e

Patch

Patch +

Source: AHRQ analysis: 2000

No combination approved by FDA

gum, puffer, nasal spray

18

Est

ima

ted

Ass

iste

d Q

uit

Att

emp

ts(i

n t

ho

usa

nd

s)

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

10,000

1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998

Year

Zyban

Inhaler

Nasal Spray

Patch

Gum

Innovation in Dissemination:OTC Marketing Increased Utilization

Burton et al, MMWR, 2000

Patch mania

OTC switch

Zyban intro

Nasal Spray

19

Behavioral treatment

Pharmacologic treatment

20

0

5

10

15

20

25

Low High

Intervention intensity

% A

bst

inen

t

Active

Placebo

Silagy meta-analysis

Pharmacological & Behavioral Treatments: Additive Effects

PharmRR = 1.9

Pharm RR = 1.5

BehRR = 1.7

BehRR = 1.9

21

Treatment Options: Approximate Effectiveness

0%

5%

10%

15%

20%

25%

30%

No Tx Brief Intensive

Behavioral Treatment

Qu

it r

ate

(%)

No meds

Medication

22

Impact of Treatment Depends on Utilization

Impact (# of quits)

=

Efficacy (% quit)

X

Utilization (# using method)

23

Treatment Options: Most Effective are Least Used

0%

5%

10%

15%

20%

25%

30%

No Tx Brief Intensive

Behavioral Treatment

Qu

it r

ate

(%)

No meds

Medication

72%

11%7%

8% 1%

1%Least effective methods most used

24

Even Among NRT Users Compliance is Poor – and it Matters

0%

10%

20%

30%

40%

50%

60%

70%

Low (4.7) High (10.5)

Number of Lozenges Per Day

% Q

uit

(6

wee

ks)

Active

Placebo

Average nicotine gum use ~ 4/day

25

Status of Cessation Treatment and Goals for Change

Efficacy

Low High

Reach

Low Present

High

26

Barriers to Treatment Use

Behavioral Tx Disconnect on

mechanism Don’t see a need Injury to esteem Doubt efficacy

Cost Mostly non-cash

Pharmacological Tx Disconnect on

mechanism Don’t see a need Injury to esteem Doubt efficacy Doubt safety Cost

Mixed empirical support

27

We Are Reaching Only The Tip of the Iceberg

Not currently interested in quitting

56%

Interested in quitting, not ready to quit now

26%

Preparing to try quitting

13%

Actually trying to quit

5%

Sources: NHIS 2000, DiClemente et al, 1991

Our Church of Perpetual Abstinence

28

Building Demand

“Build it, they will come” Marketing: product, positioning, packaging, promotion

Figure out what people want Explain what it is Explain why they need it Make it pleasant, palatable, effective Make it cool Different strokes for different folks Make it, attractive, accessible, & convenient Promote it (repeatedly) Maintain a continuing relationship & system of care

– not!

NOT!