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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA050990 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menthol very low nicotine cigarette (VLNC), then non-menthol VLNC | Experimental | 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. |
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| Non-menthol very low nicotine cigarette (VLNC), then menthol VLNC | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Very low nicotine cigarette: menthol | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Puff Topography | total inhalation volume from smoking behavior in the laboratory | Baseline to week 4 |
| Ratings of Psychological Reward | Subjective response to smoking, as measured by self-reported psychological reward (scale) of the modified Cigarette Evaluation Scale, administered after smoking. The minimum value is 1 and the maximum value is 7; with 7 indicating greater psychological reward. | Baseline to week 9 |
| Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | Purchasing of non-menthol very low nicotine cigarettes in the Experimental Tobacco Marketplace (ETM) task 1 and 2. Product units purchased per cigarette price displayed in the ETM, displayed as milligrams of nicotine. Prices are $0.12, $0.25, $0.5, $1, $2, $4, $8, and $16 per cigarette. Data are presented as units purchased on a log scale, per recommended best practices. | Assessed during tobacco purchase tasks completed at week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Exhaled CO Boost | measures expired alveolar carbon monoxide (CO) level before smoking and after smoking; measured in parts per million (ppm) | Baseline to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Withdrawal | Symptoms of nicotine withdrawal were measured using the Minnesota Nicotine Withdrawal Scale. Response options range from 0=none to 4=severe; where higher scores indicate more severe nicotine withdrawal. | Baseline to week 9 |
| Change in Cigarette Craving Before and After Smoking |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Cohn, PhD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Promotion Research Center | Oklahoma City | Oklahoma | 73104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36410805 | Derived | 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. |
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This is a within-subjects design. Participants were assigned to both smoke menthol and non-menthol very low nicotine cigarettes in visits 3 and 4 and at home for a week prior to each visit. The order of administration of menthol vs non-menthol flavor was counterbalanced to reduce the impact of order effects. The number of people to start a period may not equal the number who completed the previous period due to loss to follow-up.
N= 171 were eligible and enrolled at the first visit. N=143 people attended Visit 2 to smoke their usual brand (UB) cigarette, and n=139 were randomized to the intervention. After visit 2, the intervention began where people smoked a menthol and non-menthol VLNC (order counterbalanced) in two subsequent visits (VLNC 1 visit, VLNC 2 visit). There was a 7-day washout period between VLNC 1 and VLNC 2 smoking. The experimental tobacco marketplace was the final visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Menthol Very Low Nicotine Cigarette First | Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced. |
| FG001 | Non-menthol Very Low Nicotine Cigarette First | Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Usual Brand Smoking (Visit 2) |
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| VLNC 1 Smoking (Visit 3) |
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| 7-day Washout Period |
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| VLNC 2 Smoking (Visit 4) |
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| Experimental Tobacco Marketplace (Visit) |
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N=171 participants completed the baseline visit and were eligible at the end of that visit
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | 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. Very low nicotine cigarettes: Participants were randomized to smoke menthol and non-menthol flavored very low nicotine cigarettes in their home environment for 7 days and in the laboratory. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Puff Topography | total inhalation volume from smoking behavior in the laboratory | Analysis was restricted to individuals who completed at 2 study visits (of 3 visits). Some individuals were excluded from analysis because of missing smoking data that was not captured by the smoking topography device or several participants who erroneously smoked more than 1 cigarette. | Posted | Mean | Standard Deviation | mL | Baseline to week 4 |
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4 months
The definition does not differ. Adverse events were collected via a self-report form at the beginning of each in person visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All participants enrolled in the study, n=171 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory symptoms | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | At second study session, participant reported heart palpitations on the Adverse Events forms, prior to smoking their usual cigarette. All vitals were within range. The participant was withdrawn from the study for safety concerns. |
We focused on young adults who smoke menthol cigarettes. Findings may not generalize to non-menthol smokers or to different age groups. We did not include menthol and non-menthol normal nicotine cigarette conditions. Participants were not blinded to the cigarette nicotine content to model real-world conditions where consumers are aware of the cigarettes they smoke.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor of Pediatrics | University of Oklahoma Health Sciences | 405-271-1903 | heal-lab@ouhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2023 | Apr 9, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| Very low nicotine cigarette: non-mentol | 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 |
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1-item craving measure from the Minnesota Nicotine Withdrawal Scale. Response options range from 0 (none/not at all) to 4 (severe), where 4 indicates higher craving for a cigarette. |
| Baseline to week 9 |
| Perceived Health Risk Scale | This scale measures perceptions of risk from smoking one's usual brand or the very low nicotine cigarettes. Participants completed this questionnaire at the beginning of each in-person smoking visit (after a week of smoking the assigned cigarette at home). The measure has 7 questions. Each question has response options ranging from 1 (very low risk of disease) to 10 (very high risk of disease). Higher scores indicate greater perceived risk. The outcome reflects the total score, divided by 7 (the number of questions) | Baseline to week 8 |
| Heart Rate | Heart rate is measured as beats per minute (BPM); where higher scores indicate higher heart rate. | Baseline to week 4 |
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| years |
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| Sex: Female, Male | Data on sex missing for 1 person. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Data missing on 1 participant | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Cigarettes/day | Number of cigarettes smoked per day | Mean | Standard Deviation | unit of measure "cigarettes per day" |
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| Time-to-first cigarette | Data missing for n=1 | Count of Participants | Participants |
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| OG001 | Menthol Very Low Nicotine Cigarette | Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced. |
| OG002 | Non-menthol Very Low Nicotine Cigarette | Participants complete a within-subject design where they smoke both a menthol and a non-menthol very low nicotine cigarette; the order of administration of menthol vs non-menthol very low nicotine cigarette smoking is counterbalanced. |
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| Primary | Ratings of Psychological Reward | Subjective response to smoking, as measured by self-reported psychological reward (scale) of the modified Cigarette Evaluation Scale, administered after smoking. The minimum value is 1 and the maximum value is 7; with 7 indicating greater psychological reward. | Population included participants who completed at two study visits and who did not have any missing data on the outcomes | Posted | Mean | Standard Deviation | score on a scale | Baseline to week 9 |
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| Primary | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | Purchasing of non-menthol very low nicotine cigarettes in the Experimental Tobacco Marketplace (ETM) task 1 and 2. Product units purchased per cigarette price displayed in the ETM, displayed as milligrams of nicotine. Prices are $0.12, $0.25, $0.5, $1, $2, $4, $8, and $16 per cigarette. Data are presented as units purchased on a log scale, per recommended best practices. | We report raw data on number of non-menthol VLNCs purchased at each price. | Posted | Mean | Standard Deviation | log (mg of nicotine) | Assessed during tobacco purchase tasks completed at week 5 |
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| Secondary | Exhaled CO Boost | measures expired alveolar carbon monoxide (CO) level before smoking and after smoking; measured in parts per million (ppm) | Population included individuals who completed at least 2 study visits and who did not have any missing data. | Posted | Mean | Standard Deviation | parts per million (ppm) | Baseline to week 4 |
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| Other Pre-specified | Nicotine Withdrawal | Symptoms of nicotine withdrawal were measured using the Minnesota Nicotine Withdrawal Scale. Response options range from 0=none to 4=severe; where higher scores indicate more severe nicotine withdrawal. | Population included individuals who completed at least 2 study visits and who did not have any missing data. | Posted | Mean | Standard Deviation | score on a scale | Baseline to week 9 |
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| Other Pre-specified | Change in Cigarette Craving Before and After Smoking | 1-item craving measure from the Minnesota Nicotine Withdrawal Scale. Response options range from 0 (none/not at all) to 4 (severe), where 4 indicates higher craving for a cigarette. | Population included individuals who completed at least 2 study visits and who did not have any missing data. | Posted | Mean | Standard Deviation | score on a scale | Baseline to week 9 |
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| Other Pre-specified | Perceived Health Risk Scale | This scale measures perceptions of risk from smoking one's usual brand or the very low nicotine cigarettes. Participants completed this questionnaire at the beginning of each in-person smoking visit (after a week of smoking the assigned cigarette at home). The measure has 7 questions. Each question has response options ranging from 1 (very low risk of disease) to 10 (very high risk of disease). Higher scores indicate greater perceived risk. The outcome reflects the total score, divided by 7 (the number of questions) | Population includes individuals who attended the visit and who completed the questionnaire on perceived health risks of the cigarette flavor they smoked in the previous week. | Posted | Mean | Standard Deviation | units on a scale | Baseline to week 8 |
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| Other Pre-specified | Heart Rate | Heart rate is measured as beats per minute (BPM); where higher scores indicate higher heart rate. | Population included individuals who completed at least 2 study visits and who did not have any missing data. | Posted | Mean | Standard Deviation | beats per minute | Baseline to week 4 |
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