CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 387 enrolled
Drug / intervention
Inserts with efficacy messages +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04075682
NCT04075682N/ACompleted

Evaluation of Cigarette Package Inserts for Enhanced Communication With Smokers

University of South Carolina·interventional·Posted Sep 3, 2019·Updated May 13, 2024

In Brief

A clinical study evaluating Inserts with efficacy messages and Pictorial warnings on packs for Smoking Cessation. Completed, enrolled 387 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 3, 2019
Enrollment StartAug 1, 2019
Primary CompletionJun 29, 2021
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.8 years ago

Interventions

Inserts with efficacy messagesother

Four rotating inserts (i.e., small, printed messages) with messages about cessation benefits (i.e., response efficacy) and tips to quit (i.e., self-efficacy messages) will be placed inside cigarette packs.

Pictorial warnings on packsother

Four rotating pictorial warnings illustrating the harms of smoking will be printed on labels that will placed on and cover approximately 50% of the cigarette packs.