Cigarette Smoking Among Young Adults

NCT04340947 | Completed Results

• 2 other identifiers: ENHANCER01DA050990
• Study Type: interventional
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cigarette Smoking; Smoking Behaviors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Exhaled CO Boost

  Baseline to week 4

Other Outcomes (4)

• Nicotine Withdrawal

  Baseline to week 9

• Change in Cigarette Craving Before and After Smoking

  Baseline to week 9

• Perceived Health Risk Scale

  Baseline to week 8

Study Arms (2)

Menthol very low nicotine cigarette (VLNC), then non-menthol VLNC

EXPERIMENTAL

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; Other: Very low nicotine cigarette: non-mentol

Non-menthol very low nicotine cigarette (VLNC), then menthol VLNC

EXPERIMENTAL

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; Other: Very low nicotine cigarette: non-mentol

Interventions

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

Menthol very low nicotine cigarette (VLNC), then non-menthol VLNC; Non-menthol very low nicotine cigarette (VLNC), then menthol VLNC

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

Menthol very low nicotine cigarette (VLNC), then non-menthol VLNC; Non-menthol very low nicotine cigarette (VLNC), then menthol VLNC

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oklahoma: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

• Cohn AM, Cassidy R, Denlinger-Apte R, Donny E, Villanti AC, Hatsukami D, Dunn D, Wyatt R, Niznik T, Cohen-Davidyan T, Smith M, Ehlke SJ. Impact of a reduced nicotine standard on young adult appeal for menthol and non-menthol cigarettes. BMJ Open. 2022 Nov 21;12(11):e067694. doi: 10.1136/bmjopen-2022-067694.

  PMID: 36410805 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Limitations and Caveats

We focused on young adults who smoke menthol cigarettes. Findings may not generalize to non-menthol smokers or to different age groups. We did not include menthol and non-menthol normal nicotine cigarette conditions. Participants were not blinded to the cigarette nicotine content to model real-world conditions where consumers are aware of the cigarettes they smoke.

Results Point of Contact

• Title: Professor of Pediatrics
• Organization: University of Oklahoma Health Sciences

heal-lab@ouhsc.edu

405-271-1903

Study Officials

• Amy Cohn, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 10, 2020
• Study Start: August 1, 2021
• Primary Completion: March 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Locations

US (1)