Jean-François ETTEREvelyne LASZLO

Jean-Pierre ZELLWEGER Charles PERROT

Thomas PERNEGER

University of Geneva, Switzerland

Smoking reduction with NRT: a randomized trial

Support

This study was supported by - the Swiss National Science Foundation - the Swiss Federal Office of Public Health

Pharmacia provided nicotine and placebo products

Background

Only half of regular smokers are able to quit smoking

during their lifetime

In Europe, 60-75% of smokers have NO intention to

quit smoking in the next 6 months

These smokers will NOT participate in smoking

cessation treatments

But many are interested in REDUCING their cigarette

consumption

Objective

To assess whether NRT and placebo,

administered in a REAL LIFE situation,

REDUCED cigarette consumption

in HEAVY smokers

who did NOT want to quit smoking

Study design and participants

Design:Randomized trial with 3 arms: - nicotine, - placebo, - no treatment

Participants: 20+ cig./day, + no intention to quit smoking in next 6 months ("precontemplators"), + agreed to reduce cig./day by half

Sample and setting

Sample:- 923 at baseline, - 781 (85%) at 3 months,- 879 (95%) at 6 months

Setting: Population sample in Switzerland, 1999-2001

Intention-to-treat analysis

Intervention

6-month treatment of: – nicotine (n=265),

combination of products, choice between : 15 mg patch, 4 mg gum, and / or 10 mg inhaler

– matching placebo (n=269)

– no intervention (n=389)

Intervention

Products were sent to participants by mail

Education was limited to a booklet

No in-person contacts, no telephone counseling

Results: cigarette consumption

Baseline = 30 cig. / day Considering that participants lost to follow-up

maintained their cigarette consumption, median reductions (cig. / day) were:

3 months 6 months

Nicotine 10 10

Placebo 5 7.5

Control 0 2.5

P values all <0.001 all <0.04

Results: mean daily cigarette consumption

05

101520253035

Baseline 3 months 6 months

Nicotine Placebo Control

Results: change in cig./day after 6 months

-25

-20

-15

-10

-5

0

Nicotine Placebo ControlCPD: 20 25 30 40 50

Results: smoking cessation after 6 months

Criterion: no puff of tobacco in past 4 weeks (FDA)4.2

3.9

1.9

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

Nicotine vs. Placebo, p=0.12

Nicotine

Placebo

Control

Results: 24-hour quit attempts

28 27

21

0

5

10

15

20

25

30

Nicotine vs. Placebo, p=0.04

Nicotine

Placebo

Control

Results: motivation to quit smoking

5.9 6.1

0

5.8

0

1

2

3

4

5

6

7In

ten

tio

n (

0-10

)

Nicotine

Placebo

Control

Histogramme4

Limitations of this study

No biochemical measure - real-life setting - which measure ?

Impact on exposure ?

Impact on health ? - long-term studies

Conclusions (1)

Both NRT and placebo helped smokers reduce their cigarette consumption and maintain this reduction over 6 months

The treatment was effective in the absence of medical guidance or supervision

Conclusions (2)

Large placebo effect, in particular in smokers of >30 cig./day (3rd control group)

The treatment had no deleterious impact on smoking cessation, quit attempts and motivation to quit smoking

Published in J Clin Psychopharmacol 2002;22:487-95.