Cigarette Smoking, Smoking Behaviors
Conditions
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.
Interventions
OTHERVery low nicotine cigarette: menthol
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
OTHERVery low nicotine cigarette: non-mentol
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
Sponsors
National Institute on Drug Abuse (NIDA)
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 34 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Puff Topography | Baseline to week 4 | total inhalation volume from smoking behavior in the laboratory |
| Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | Assessed during tobacco purchase tasks completed at week 5 | 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. |
| Ratings of Psychological Reward | Baseline to week 9 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exhaled CO Boost | Baseline to week 4 | measures expired alveolar carbon monoxide (CO) level before smoking and after smoking; measured in parts per million (ppm) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Baseline to week 4 | Heart rate is measured as beats per minute (BPM); where higher scores indicate higher heart rate. |
| Perceived Health Risk Scale | Baseline to week 8 | 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) |
| Change in Cigarette Craving Before and After Smoking | Baseline to week 9 | 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. |
| Nicotine Withdrawal | Baseline to week 9 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 171 |
| Total | 171 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 7-day Washout Period | Lost to Follow-up | 5 | 4 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 25.16 years STANDARD_DEVIATION 4.41 |
| Cigarettes/day | 8.86 unit of measure cigarettes per day STANDARD_DEVIATION 6.58 |
| Race/Ethnicity, Customized Hispanic | 22 Participants |
| Race/Ethnicity, Customized Non-hispanic Black | 22 Participants |
| Race/Ethnicity, Customized Non-hispanic other race | 25 Participants |
| Race/Ethnicity, Customized Non-hispanic white | 102 Participants |
| Region of Enrollment United States | 171 participants |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 87 Participants |
| Time-to-first cigarette Smoke within 5 minutes of waking | 36 Participants |
| Time-to-first cigarette Smoke within 6 or more minutes after waking | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 171 |
| other Total, other adverse events | 1 / 171 |
| serious Total, serious adverse events | 0 / 171 |
Outcome results
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.
Time frame: Assessed during tobacco purchase tasks completed at week 5
Population: We report raw data on number of non-menthol VLNCs purchased at each price.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Brand Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $0.12 | 20.40 log (mg of nicotine) | Standard Deviation 36.22 |
| Usual Brand Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $0.25 | 14.44 log (mg of nicotine) | Standard Deviation 26.64 |
| Usual Brand Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $0.50 | 10.17 log (mg of nicotine) | Standard Deviation 19.25 |
| Usual Brand Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $1.00 | 5.68 log (mg of nicotine) | Standard Deviation 14.64 |
| Usual Brand Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $2.00 | 2.56 log (mg of nicotine) | Standard Deviation 7.56 |
| Usual Brand Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $4.00 | 1.16 log (mg of nicotine) | Standard Deviation 6.04 |
| Usual Brand Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $8.00 | 0.44 log (mg of nicotine) | Standard Deviation 2.13 |
| Usual Brand Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $16.00 | 0.25 log (mg of nicotine) | Standard Deviation 1.51 |
| Menthol Very Low Nicotine Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $16.00 | 0.02 log (mg of nicotine) | Standard Deviation 0.13 |
| Menthol Very Low Nicotine Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $0.12 | 6.11 log (mg of nicotine) | Standard Deviation 18.38 |
| Menthol Very Low Nicotine Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $2.00 | 1.18 log (mg of nicotine) | Standard Deviation 6.33 |
| Menthol Very Low Nicotine Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $0.25 | 3.66 log (mg of nicotine) | Standard Deviation 13.11 |
| Menthol Very Low Nicotine Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $8.00 | 0.06 log (mg of nicotine) | Standard Deviation 0.43 |
| Menthol Very Low Nicotine Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $0.50 | 3.37 log (mg of nicotine) | Standard Deviation 12.21 |
| Menthol Very Low Nicotine Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $4.00 | 0.34 log (mg of nicotine) | Standard Deviation 1.69 |
| Menthol Very Low Nicotine Cigarette | Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs) | $1.00 | 1.68 log (mg of nicotine) | Standard Deviation 7.21 |
Primary
Puff Topography
total inhalation volume from smoking behavior in the laboratory
Time frame: Baseline to week 4
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette | Puff Topography | 1108 mL | Standard Deviation 1013.7 |
| Menthol Very Low Nicotine Cigarette | Puff Topography | 1045.2 mL | Standard Deviation 1119.4 |
| Non-menthol Very Low Nicotine Cigarette | Puff Topography | 1084.6 mL | Standard Deviation 1141 |
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.
Time frame: Baseline to week 9
Population: Population included participants who completed at two study visits and who did not have any missing data on the outcomes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette | Ratings of Psychological Reward | 3.1 score on a scale | Standard Deviation 1.3 |
| Menthol Very Low Nicotine Cigarette | Ratings of Psychological Reward | 2.9 score on a scale | Standard Deviation 1.4 |
| Non-menthol Very Low Nicotine Cigarette | Ratings of Psychological Reward | 2.3 score on a scale | Standard Deviation 1.3 |
Secondary
Exhaled CO Boost
measures expired alveolar carbon monoxide (CO) level before smoking and after smoking; measured in parts per million (ppm)
Time frame: Baseline to week 4
Population: Population included individuals who completed at least 2 study visits and who did not have any missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Brand Cigarette | Exhaled CO Boost | Before smoking | 4.08 parts per million (ppm) | Standard Deviation 5.03 |
| Usual Brand Cigarette | Exhaled CO Boost | After smoking | 9.17 parts per million (ppm) | Standard Deviation 9.42 |
| Menthol Very Low Nicotine Cigarette | Exhaled CO Boost | Before smoking | 3.72 parts per million (ppm) | Standard Deviation 4.16 |
| Menthol Very Low Nicotine Cigarette | Exhaled CO Boost | After smoking | 7.65 parts per million (ppm) | Standard Deviation 6.84 |
| Non-menthol Very Low Nicotine Cigarette | Exhaled CO Boost | Before smoking | 3.9 parts per million (ppm) | Standard Deviation 5.12 |
| Non-menthol Very Low Nicotine Cigarette | Exhaled CO Boost | After smoking | 6.79 parts per million (ppm) | Standard Deviation 6.8 |
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.
Time frame: Baseline to week 9
Population: Population included individuals who completed at least 2 study visits and who did not have any missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette | Change in Cigarette Craving Before and After Smoking | 2.18 score on a scale | Standard Deviation 1.38 |
| Menthol Very Low Nicotine Cigarette | Change in Cigarette Craving Before and After Smoking | 1.92 score on a scale | Standard Deviation 1.43 |
| Non-menthol Very Low Nicotine Cigarette | Change in Cigarette Craving Before and After Smoking | 1.85 score on a scale | Standard Deviation 1.33 |
Other Pre-specified
Heart Rate
Heart rate is measured as beats per minute (BPM); where higher scores indicate higher heart rate.
Time frame: Baseline to week 4
Population: Population included individuals who completed at least 2 study visits and who did not have any missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Brand Cigarette | Heart Rate | After smoking | 85.73 beats per minute | Standard Deviation 14.06 |
| Usual Brand Cigarette | Heart Rate | Before smoking | 76.85 beats per minute | Standard Deviation 12.38 |
| Menthol Very Low Nicotine Cigarette | Heart Rate | Before smoking | 75.03 beats per minute | Standard Deviation 13.62 |
| Menthol Very Low Nicotine Cigarette | Heart Rate | After smoking | 75.72 beats per minute | Standard Deviation 14.38 |
| Non-menthol Very Low Nicotine Cigarette | Heart Rate | Before smoking | 77.25 beats per minute | Standard Deviation 12.77 |
| Non-menthol Very Low Nicotine Cigarette | Heart Rate | After smoking | 76.42 beats per minute | Standard Deviation 13 |
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.
Time frame: Baseline to week 9
Population: Population included individuals who completed at least 2 study visits and who did not have any missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Brand Cigarette | Nicotine Withdrawal | Before smoking | 0.54 score on a scale | Standard Deviation 0.47 |
| Usual Brand Cigarette | Nicotine Withdrawal | After smoking | .26 score on a scale | Standard Deviation 0.29 |
| Menthol Very Low Nicotine Cigarette | Nicotine Withdrawal | Before smoking | 0.48 score on a scale | Standard Deviation 0.41 |
| Menthol Very Low Nicotine Cigarette | Nicotine Withdrawal | After smoking | .27 score on a scale | Standard Deviation 0.3 |
| Non-menthol Very Low Nicotine Cigarette | Nicotine Withdrawal | Before smoking | 0.47 score on a scale | Standard Deviation 0.45 |
| Non-menthol Very Low Nicotine Cigarette | Nicotine Withdrawal | After smoking | .30 score on a scale | Standard Deviation 0.29 |
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)
Time frame: Baseline to week 8
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Brand Cigarette | Perceived Health Risk Scale | 5.30 units on a scale | Standard Deviation 2.2 |
| Menthol Very Low Nicotine Cigarette | Perceived Health Risk Scale | 4.45 units on a scale | Standard Deviation 2.28 |
| Non-menthol Very Low Nicotine Cigarette | Perceived Health Risk Scale | 4.45 units on a scale | Standard Deviation 2.18 |