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Open Access Study protocol

Plain packaging of cigarettes and smoking behavior: study protocol for a randomized controlled study

Olivia M Maynard123*, Ute Leonards3, Angela S Attwood123, Linda Bauld24, Lee Hogarth5 and Marcus R Munafò123

Author Affiliations

1 MRC Integrative Epidemiology Unit, University of Bristol, Oakfield House, Oakfield Grove, Bristol BS8 2BN, UK

2 UK Centre for Tobacco and Alcohol Studies, Clinical Sciences Building, City Hospital, Nottingham NG5 1PB, UK

3 School of Experimental Psychology, University of Bristol, 12a Priory Road, Bristol BS8 1TU, UK

4 Institute of Social Marketing, University of Stirling, Stirling FK9 4LA, UK

5 Department of Psychology, College of Life and Environmental Sciences, University of Exeter, Washington Singer Building, Perry Road, Exeter EX4 4QG, UK

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Trials 2014, 15:252  doi:10.1186/1745-6215-15-252

Published: 25 June 2014

Abstract

Background

Previous research on the effects of plain packaging has largely relied on self-report measures. Here we describe the protocol of a randomized controlled trial investigating the effect of the plain packaging of cigarettes on smoking behavior in a real-world setting.

Methods/Design

In a parallel group randomization design, 128 daily cigarette smokers (50% male, 50% female) will attend an initial screening session and be assigned plain or branded packs of cigarettes to smoke for a full day. Plain packs will be those currently used in Australia where plain packaging has been introduced, while branded packs will be those currently used in the United Kingdom. Our primary study outcomes will be smoking behavior (self-reported number of cigarettes smoked and volume of smoke inhaled per cigarette as measured using a smoking topography device). Secondary outcomes measured pre- and post-intervention will be smoking urges, motivation to quit smoking, and perceived taste of the cigarettes. Secondary outcomes measured post-intervention only will be experience of smoking from the cigarette pack, overall experience of smoking, attributes of the cigarette pack, perceptions of the on-packet health warnings, behavior changes, views on plain packaging, and the rewarding value of smoking. Sex differences will be explored for all analyses.

Discussion

This study is novel in its approach to assessing the impact of plain packaging on actual smoking behavior. This research will help inform policymakers about the effectiveness of plain packaging as a tobacco control measure.

Trial registration

Current Controlled Trials ISRCTN52982308 (registered 27 June 2013).

Keywords:
Smoking; Plain packaging; Standardized packaging; Randomized controlled trial; Health warnings; Smoking behavior