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Completed

NCT Number: NCT04340947

Cigarette Smoking Among Young Adults

This study will examine perceptions and smoking behavior of menthol and non-menthol very low nicotine cigarettes in young adult smokers. The aims are to examine perceptions and smoking behavior in the laboratory and in the natural environment. A separate sub-sample of men and women who identify as LGBTQ2S+ will also be recruited.

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Key information

Age range

18 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

About this study

This proposal includes three different aspects of assessment for menthol smoking young adults. The laboratory phase includes three separate sessions of laboratory smoking through a machine designed to measure puff behavior; the EMA phase includes 21 days of monitoring smoking behavior and attitudes related to smoking when smoking one's usual brand cigarette, the assigned menthol low nicotine cigarette, and the assigned non-menthol low nicotine cigarette in the participant's natural environment. The order of administration of smoking menthol and non-menthol VLNC will be counterbalanced. There will be a 7-day wash-out period between each 7-day period of using low nicotine cigarettes. The final phase includes a virtual marketplace where participants can purchase and use the research cigarettes in the context of other available tobacco products on the market, or purchase no tobacco products at all. There will be a final assessment, over the phone or in-person, 30-days after the final study visit (at week 8), to assess tobacco use behavior and attitudes about tobacco use. Participants will be enrolled for approximately 9 weeks. Week 1 will consist of smoking one's usual brand of cigarette in the laboratory and then in their home environment for 7-days. Week 2 will consist of smoking the first very low nicotine cigarette in the home environment for 7 days and then in the laboratory. Week three will consist of a 7-day wash-out period where participants can smoke their usual brand again, as they normally would. Week 4 will consist of smoking the second very low nicotine cigarette at home for 7 days and then in the laboratory. Week 5 will consist of returning to the laboratory for a final study visit and complete a hypothetical experimental tobacco marketplace. One month (4 weeks) after the final study visit (week 9), participants will complete a 30-day follow-up of cigarette smoking and other tobacco use behavior.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ages18 to 34;
  • Smoke cigarettes "somedays" or "everyday" for at least the past 3-months;
  • A strong preference for menthol cigarettes (i.e., smoke menthol >80% of the time); and
  • Ability to read English at an 8th grade level or higher;
  • No immediate plans to quit smoking.

Exclusion criteria

  • Current use of nicotine replacement therapy (NRT);
  • Pregnant or planning to become pregnant, or currently breastfeeding;
  • Past or current self-reported clinically significant heart disease or hypertension, or other smoking-related disease (by history) that preclude successful study completion;
  • Serious psychiatric disorder;
  • Inability to abstain from nicotine/tobacco products;
  • Strong preference for non-menthol cigarettes (smoke non-menthol > 80% of the time)

Treatment and study plan

Very low nicotine cigarette: menthol

Other

Participants will be randomized to smoke either menthol non-menthol flavored very low nicotine cigarettes in their home environment for 7 days and in the laboratory first and then crossed over to receive the opposite intervention. The study consists of two treatment periods of 7 days separated by a 1 week wash-out period

Very low nicotine cigarette: non-mentol

Other

Participants will be randomized to smoke either menthol non-menthol flavored very low nicotine cigarettes in their home environment for 7 days and in the laboratory first and then crossed over to receive the opposite intervention. The study consists of two treatment periods of 7 days separated by a 1 week wash-out period

Primary outcomes

  1. Puff Topography

    Time frame: Baseline to week 4

    total inhalation volume from smoking behavior in the laboratory

  2. Ratings of Psychological Reward

    Time frame: Baseline to week 9

    Subjective response to smoking, as measured by self-reported psychological reward (scale) of the modified Cigarette Evaluation Scale, administered after smoking. The minimum value is 1 and the maximum value is 7; with 7 indicating greater psychological reward.

  3. Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs)

    Time frame: Assessed during tobacco purchase tasks completed at week 5

    Purchasing of non-menthol very low nicotine cigarettes in the Experimental Tobacco Marketplace (ETM) task 1 and 2. Product units purchased per cigarette price displayed in the ETM, displayed as milligrams of nicotine. Prices are $0.12, $0.25, $0.5, $1, $2, $4, $8, and $16 per cigarette. Data are presented as units purchased on a log scale, per recommended best practices.

Secondary outcomes

  1. Exhaled CO Boost

    Time frame: Baseline to week 4

    measures expired alveolar carbon monoxide (CO) level before smoking and after smoking; measured in parts per million (ppm)

Other outcomes

  1. Nicotine Withdrawal

    Time frame: Baseline to week 9

    Symptoms of nicotine withdrawal were measured using the Minnesota Nicotine Withdrawal Scale. Response options range from 0=none to 4=severe; where higher scores indicate more severe nicotine withdrawal.

  2. Change in Cigarette Craving Before and After Smoking

    Time frame: Baseline to week 9

    1-item craving measure from the Minnesota Nicotine Withdrawal Scale. Response options range from 0 (none/not at all) to 4 (severe), where 4 indicates higher craving for a cigarette.

  3. Perceived Health Risk Scale

    Time frame: Baseline to week 8

    This scale measures perceptions of risk from smoking one's usual brand or the very low nicotine cigarettes. Participants completed this questionnaire at the beginning of each in-person smoking visit (after a week of smoking the assigned cigarette at home). The measure has 7 questions. Each question has response options ranging from 1 (very low risk of disease) to 10 (very high risk of disease). Higher scores indicate greater perceived risk. The outcome reflects the total score, divided by 7 (the number of questions)

  4. Heart Rate

    Time frame: Baseline to week 4

    Heart rate is measured as beats per minute (BPM); where higher scores indicate higher heart rate.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Impact of a Reduced Nicotine Standard on Young Adult Appeal for Menthol and Non-menthol Cigarettes

Acronym: ENHANCE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2020
Registry last updated
Aug 22, 2025

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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