Cigarette Pack Inserts for Smoking Cessation

University of South Carolina

Status: Completed

Conditions: Smoking Cessation

Treatments: Other: Pictorial warnings on packs; Other: Inserts with efficacy messages

Study type: Interventional

Funder types: Other

Identifiers

NCT04075682

Pro00083728

Details and patient eligibility

About

This study will test whether cigarette package inserts (i.e., small printed leaflets inside cigarette packs) with messages about the benefits of cessation and tips for quitting can help smokers quit. To do this, the investigators will conduct a 2 X 2 between-subject experiment in which 380 smokers will be randomized into one of four labeling groups: 1. no inserts or pictorial health warning labels (HWLs); 2. inserts only; 3. pictorial HWLs only; 4. inserts & pictorial HWLs. Smokers will be given a 14-day supply of their preferred cigarette brand with packs labeled according to their experimental group. Participants will answer a brief survey at the end of each day and four other times each day, using ecological momentary assessment approaches. The investigators will study whether smokers in each group experience different psychological responses and behaviors associated with smoking cessation.

Enrollment: 387 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 or older
• Have smoked at least 100 cigarettes in their lifetime
• Smoked at least 10 cigarettes a day in the prior month.

Exclusion criteria

• Use of other nicotine products besides cigarettes in the prior month.
• Pregnant women

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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387 participants in 4 patient groups

Standard cigarette packs (control)

No Intervention group

Description:

Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with the only alteration being the small health warning message on the side of the pack, whose textual content will be the same as that used for the pictorial warning label conditions.

Cigarette packs with inserts only

Experimental group

Description:

Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include inserts with four different rotating messages to promote response efficacy beliefs (2 inserts on the benefits of cessation) or self-efficacy to quit (2 inserts with cessation tips).

Treatment:

Other: Inserts with efficacy messages

Cigarette packs with pictorial warnings only

Experimental group

Description:

Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include four different rotating pictorial warnings showing the consequences of smoking and that cover 50% of the front and back of the pack.

Treatment:

Other: Pictorial warnings on packs

Cigarette packs with inserts and pictorial warnings

Experimental group

Description:

Participants will be provided with a 2 week supply of their preferred brand of cigarettes, with packs altered to include inserts with four rotating efficacy messages (see description above) and four rotating pictorial warnings (see above).

Treatment:

Other: Pictorial warnings on packs

Other: Inserts with efficacy messages