Clinical trial NCT04340947: Cigarette Smoking Among Young Adults
Official title: Impact of a Reduced Nicotine Standard on Young Adult Appeal for Menthol and Non-menthol Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Smoking Behaviors
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Change in puff topography
timeFrame: Baseline to week 4
measure: Change in Cigarette Evaluation Scale (CES)
timeFrame: Baseline to week 9
measure: Hypothetical Purchasing of Tobacco Products
timeFrame: Assessed during tobacco purchase tasks completed at week 5
Secondary outcomes:
measure: Change in CO boost
timeFrame: Baseline to week 4
Other outcomes:
measure: Drop-out rate
timeFrame: From baseline (Visit 1) to week 9
measure: Minnesota Nicotine Withdrawal Scale (MNWS)
timeFrame: Baseline to week 9
measure: Questionnaire of Smoking Urges (QSU)
timeFrame: Baseline to week 9
measure: Positive and Negative Affect Scale (PANAS)
timeFrame: Baseline to week 4
measure: Perceived Health Risk Scale
timeFrame: Baseline to week 8
measure: Heart rate
timeFrame: Baseline to week 4
measure: Blood pressure
timeFrame: Baseline to week 4
Locations:
city: Oklahoma City
country: United States
facility: Health Promotion Research Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Amy Cohn, PhD
role: PRINCIPAL_INVESTIGATOR
References: