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OpenTrials
Completed

NCT Number: NCT03402243

Effect of Banning Menthol Flavorant on Cigarette and E-Cigarette Use

In this pilot study, menthol cigarette smokers will be randomized to one of three experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes (condition A); 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes (Condition B); and 3) a condition in which menthol is not banned for either product (Condition C - the control condition). All conditions would have medicinal nicotine available if subjects decide to quit tobacco products entirely. At visits occurring every two weeks over a 6 week period, subjects will receive "credits" that they could exchange for any product available in their randomized marketplace condition. Outcomes include the amount of each tobacco product used.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical and Translational Sciences Institute

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Be between the ages of 18 and 64
  • Purchase exclusively menthol cigarettes
  • Not currently motivated to quit smoking
  • Smoking a minimum number of cigarettes per day

Exclusion criteria

  • Report a serious, unstable medical or psychiatric condition
  • Use any medications that might interfere with measures to be studied (for example, medications known to affect smoking)
  • Have used any smoking cessation therapy during the past month
  • Regularly use any form of tobacco other than cigarettes
  • Are pregnant or breast feeding or planning to become pregnant or breast feed during the study

Treatment and study plan

Menthol ban on cigarettes

Other

Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes

Menthol ban on cigarettes and e-cigarettes

Other

Participants will have neither menthol flavored cigarettes or e-cigarettes available

No menthol ban

Other

Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available

Primary outcomes

  1. Amount of Tobacco Product Used

    Time frame: 6 weeks

    Total number of cigarettes smoked and puffs of e-cigarettes used

Secondary outcomes

  1. How Much of Each Product is Obtained From the "Experimental Marketplace"

    Time frame: 6 weeks

    Number of packs of cigarettes obtained and amount of e-liquid obtained from the "experimental marketplace"

  2. Motivation to Quit Smoking Cigarettes

    Time frame: 6 weeks

    Based on a question asking how motivated from 1 (not at all) to 10 (extremely) the participant is to quit smoking cigarettes at this time

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2018
Registry last updated
Aug 10, 2021

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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