Cigarette Smoking Among Young Adults

Cigarette Smoking Clinical Trial

— ENHANCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04340947
• Other study ID #: ENHANCE
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Oklahoma
• Contact: Project Coordinator
• Phone: 405-271-7759
• Email: MyHealth[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 34 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cigarette Smoking
• Smoking Behaviors

Intervention

Other:
• Very low nicotine cigarettes
Participants will be randomized to smoke menthol and non-menthol flavored very low nicotine cigarettes in their home environment for 7 days and in the laboratory

Locations

Country	Name	City	State
United States	Health Promotion Research Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Drop-out rate	Measure of compliance	From baseline (Visit 1) to week 9
Other	Minnesota Nicotine Withdrawal Scale (MNWS)	Measures withdrawal symptoms	Baseline to week 9
Other	Questionnaire of Smoking Urges (QSU)	Measures craving	Baseline to week 9
Other	Positive and Negative Affect Scale (PANAS)	Measures affect	Baseline to week 4
Other	Perceived Health Risk Scale	Measures perceptions of risk of smoking	Baseline to week 8
Other	Heart rate	Measures cardiovascular function	Baseline to week 4
Other	Blood pressure	Measures cardiovascular function assessed through both systolic and diastolic pressures	Baseline to week 4
Primary	Change in puff topography	total inhalation volume from smoking behavior in the laboratory	Baseline to week 4
Primary	Change in Cigarette Evaluation Scale (CES)	Subjective response to smoking	Baseline to week 9
Primary	Hypothetical Purchasing of Tobacco Products	Purchasing of cigarettes and other tobacco products across changing prices in Experimental Tobacco Marketplace task	Assessed during tobacco purchase tasks completed at week 5
Secondary	Change in CO boost	measures expired alveolar carbon monoxide level	Baseline to week 4