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Completed

NCT Number: NCT03075839

Impact of Switching to Non-Menthol Cigarettes Among Smokers

This pilot study will investigate within-person changes in smoking behavior when current adult smokers are systematically switched from smoking menthol cigarettes to non-menthol cigarettes.

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Key information

Conditions

Tobacco Use Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06511, United States

About this study

The goals of this project include evaluating the feasibility of a cigarette switching paradigm to examine how switching adult smokers from menthol to non-menthol cigarettes impacts smoking behavior and satisfaction. Smoking behavior will be measured by self-reported total number of cigarettes and time to first cigarette in the morning, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3). Smoking satisfaction will be measured by self-reported ratings of the cigarettes, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 or older
  • Able to read English
  • Cigarette smoker

Exclusion criteria

  • Seeking smoking cessation treatment
  • Serious psychiatric or medical condition
  • Use of other drugs
  • Unable or unwilling to complete study protocol

Treatment and study plan

Cigarette Brand Switching

Other

Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of two weeks

Primary outcomes

  1. Total Number of Cigarettes Smoked

    Time frame: Menthol smoking (Week 2), Non-menthol smoking (Week 4)

    Change in self-reported total number of cigarettes smoked per day after switching to non-menthol cigarettes

Secondary outcomes

  1. Nicotine Dependence

    Time frame: Week 4 (non-menthol)

    Self-reported subjective ratings of nicotine dependence after switching to non-menthol cigarettes (measured as change in Wisconsin Inventory of Smoking Dependence Motives (WISDM) total dependence scores). Total range 11-77 with higher scores indicating greater nicotine dependence.

  2. Quitting Interest

    Time frame: Week 4 (non-menthol)

    Self-reported subjective motivation/interest in quitting smoking after switching to non-menthol cigarettes. Measured by the item "how important is quitting smoking to you?" from 1 "not at all" to 10 "extremely".

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Food and Drug Administration (FDA)
  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2017
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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