Cigarette Smoking Among Young Adults (ENHANCE)

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

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking; Smoking Behaviors
• Intervention / Treatment: Other: Very low nicotine cigarette: menthol; Other: Very low nicotine cigarette: non-mentol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Health Promotion Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Menthol very low nicotine cigarette (VLNC), then non-menthol VLNC; Participants will smoke menthol flavored very low nicotine cigarettes in their home environment for 7 days. At the end of 7-days, they will also smoke one menthol flavored very low nicotine cigarette in the laboratory.	Other: Very low nicotine cigarette: menthol; 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; Other: Very low nicotine cigarette: non-mentol; 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
Experimental: Non-menthol very low nicotine cigarette (VLNC), then menthol VLNC; Participants will smoke non-menthol flavored very low nicotine cigarettes in their home environment for 7 days. At the end of 7-days, they will also smoke one non-menthol flavored very low nicotine cigarette in the laboratory.	Other: Very low nicotine cigarette: menthol; 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; Other: Very low nicotine cigarette: non-mentol; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puff Topography	total inhalation volume from smoking behavior in the laboratory	Baseline to week 4
Ratings of Psychological Reward	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.	Baseline to week 9
Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs)	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.	Assessed during tobacco purchase tasks completed at week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exhaled CO Boost	measures expired alveolar carbon monoxide (CO) level before smoking and after smoking; measured in parts per million (ppm)	Baseline to week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nicotine Withdrawal	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.	Baseline to week 9
Change in Cigarette Craving Before and After Smoking	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.	Baseline to week 9
Perceived Health Risk Scale	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)	Baseline to week 8
Heart Rate	Heart rate is measured as beats per minute (BPM); where higher scores indicate higher heart rate.	Baseline to week 4

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Amy Cohn, PhD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Dermatologic Agents; Neurotransmitter Agents; Antipruritics; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine; Menthol
• Other Study ID Numbers: Enhance; R01DA050990 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No