Cigarette Smoking Clinical Trial
— ENHANCEOfficial title:
Impact of a Reduced Nicotine Standard on Young Adult Appeal for Menthol and Non-menthol Cigarettes
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Health Promotion Research Center | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma |
United States,
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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