N/A N=387 Randomized Single-blind Prevention

Cigarette Pack Inserts for Smoking Cessation

Smoking Cessation

Bottom Line

View on ClinicalTrials.gov: NCT04075682 ↗

Enrolled (actual)

387

Serious AEs

0.5%

Results posted

May 2024

Primary outcome: Primary: Self-efficacy to Quit Smoking — 2.61; 2.76; 2.62; 2.56 score on a scale — p=0.60

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Inserts with efficacy messages (Other); Pictorial warnings on packs (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of South Carolina
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Self-efficacy to Quit Smoking	2.61; 2.76; 2.62; 2.56	0.60
PRIMARY Self-efficacy to Cut Down on Smoking	3.15; 3.52; 3.29; 3.18	0.57
PRIMARY Worry About Harms From Smoking	4.34; 4.84; 4.46; 4.47	0.57
PRIMARY Strength of Feeling About Smoking	3.98; 3.75; 3.71; 3.85	0.40
PRIMARY Extent of Motivation to Quit Smoking	3.63; 4.00; 3.76; 3.62	0.45
PRIMARY Talk About Smoking Cessation	0.1589; 0.1645; 0.1833; 0.1898	0.29
PRIMARY Foregoing a Cigarette	0.3882; 0.5479; 0.4916; 0.5807	0.001 sig
SECONDARY Strength of Hopefulness About Quitting	3.80; 4.25; 3.96; 3.86	0.41
SECONDARY Extent of Cognitive Elaboration of Smoking Benefits	3.19; 3.20; 3.16; 3.17	0.45
SECONDARY Extent of Cognitive Elaboration of Smoking Harms	3.91; 4.40; 3.95; 4.15	0.36
SECONDARY Extent of Cognitive Elaboration of Cessation Benefits	4.07; 4.62; 4.13; 4.34	0.04 sig
SECONDARY Strength of Beliefs About Benefits of Smoking Cessation (i.e., Response Efficacy)	4.69; 5.18; 4.96; 4.95	0.25
SECONDARY Strength of Perceived Susceptibility to Smoking Harms	4.95; 5.53; 5.21; 5.21	0.58
SECONDARY Expressed Reactance Against Health Messages	0.0103; 0.0194; 0.0369; 0.0157	0.83
SECONDARY Satisfaction From Smoking	4.95; 4.89; 4.74; 4.83	0.37
SECONDARY Cigarettes Logged	181.1; 185.9; 190.3; 185.8	0.92

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04075682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.