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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04340947
Other study ID # ENHANCE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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