Cigarette Smoking Among Young Adults

NCT ID: NCT04340947

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2024-04-30

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.

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.

Conditions

Cigarette Smoking; Smoking Behaviors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Very low nicotine cigarette: menthol

Intervention Type: 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

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Very low nicotine cigarette: menthol

Intervention Type: 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

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Cohn, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

Health Promotion Research Center

Oklahoma City, Oklahoma, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36410805 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DA050990

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ENHANCE

Identifier Type: -

Identifier Source: org_study_id