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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA046333-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Vermont | OTHER |
| Brown University | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) |
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The goal of the proposed study is to examine the abuse liability and substitutability of plausible menthol cigarette alternatives currently on the market, including menthol filtered little cigars (mFLC), menthol roll-your-own (mRYO) pipe tobacco and cigarette tubes, and non-menthol cigarettes (nmC). In addition, the study will elucidate real-time mechanisms including product characteristics and perceived effects associated with greater substitution.
Using an in-laboratory and ad libitum outpatient mixed design, 80 current menthol cigarette smokers will complete a three phase, 3 week study: in Phase 1, utilizing a randomized crossover design, participants will complete 5 smoking sessions, each session smoking a different product examining each participants puff topography while sampling the product, the products' ability to suppress nicotine craving/withdrawal, and the product's demand indices. Products will include participants usual brand menthol cigarette (UBMC) as well as 3 commercially-available alternatives, including an mFLC, a pre-assembled mRYO product (menthol tobacco and non-menthol tube), and an nmC. All sessions will occur following 12 hours of nicotine abstinence and be separated by 48 hours. In Phase 2, participants will select their preferred study product from Phase 1 and be instructed to completely substitute the product for their UBMC for one week. Participants will complete ecological momentary assessments (EMA) during this period to more accurately assess degree of substitution and perceived effects in real time. In Phase 3, participants will complete a final in-lab visit to assess the substitutability of their preferred product, under simulated ban conditions using a progressive ratio task. In all phases, multiple domains of abuse liability will be assessed, including product administration (in-lab puff topography and EMA self-report measures), product liking and craving and withdrawal suppression (in-lab and EMA self-report), and a hypothetical purchase task to simulate demand.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual brand menthol cigarette (UBMC) | Active Comparator | Study participant's usual brand menthol cigarette |
|
| menthol roll-your-own cigarette (mRYO) | Active Comparator | Mentholated pipe tobacco in a roll-your-own cigarette tube |
|
| menthol filtered little cigar (mFLC) | Active Comparator | The menthol filtered cigar will be Cheyenne (Cheyennecigars.com) Seneca (senecacigars.com) |
|
| non-menthol cigarette (nmC) | Active Comparator | The non-menthol cigarette will be Newport non-menthol cigarettes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menthol cigarettes substitutes | Behavioral | In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability. |
| Measure | Description | Time Frame |
|---|---|---|
| Puffing Topography: Puff Duration | Average puff duration for each participant, in seconds. | Phase 1, Four visits; 20 minute puffing session in total. |
| Puffing Topography: Inter-puff-interval | Inter-puff-interval, the average time between each puff for each participant, in seconds. | Phase 1, Four visits; 20 minute puffing session in total. |
| Puffing Topography: Puff Flow Rate | Puff flow rate, the average rate of air flow during each puff for each participant, in ml/second. | Phase 1, Four visits; 20 minute puffing session in total. |
| Puffing Topography: Total Puff Volume | The total volume of all puffs taken for each participant, in ml. | Phase 1, Four visits; 20 minute puffing session in total. |
| Drug Effects/Liking Questionnaire | An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of UBMC and all three study products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness. Five visual analog scale items ranging from 0 ('not at all') to 100 ('extremely') assessed wanting to smoke the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying. | Phases 1 and 3 - Up to 3 weeks |
| Modified Cigarette Evaluation Questionnaire (mCEQ) | The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective responses to cigarettes (e.g., reward, satisfaction). The 11-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, an craving reduction. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theodore Wagener, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37963771 | Derived | Villanti AC, Hinton A, Schulz JA, Erath TG, Mehta T, Reed D, Tidey J, Businelle M, Wagener TL. Substitutability of menthol cigarette alternatives: a clinical trial. Tob Control. 2025 Apr 1;34(2):154-161. doi: 10.1136/tc-2023-058272. |
| Label | URL |
|---|---|
| Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | UBMC - Menthol Roll Your Own - Menthol Filtered Little Cigars - Non-menthol Cigarettes | In phase 1, participants first use their usual brand menthol cigarettes, then they try menthol roll your own, followed by menthol filtered little cigars, and non-menthol cigarettes during 4 separate lab visits. In phase 2, participants then substituted the product of their choice for their UBMC for 1 week and completed daily diaries. In phase 3, one final lab visit was conducted with the product chosen prior. |
| FG001 | UBMC - Menthol Roll Your Own - Non-menthol Cigarettes - Menthol Filtered Little Cigars | In phase 1, participants first use their usual brand menthol cigarettes, then they try menthol roll your own, followed by non-menthol cigarettes, and menthol filtered little cigars during 4 separate lab visits. In phase 2, participants then substituted the product of their choice for their UBMC for 1 week and completed daily diaries. In phase 3, one final lab visit was conducted with the product chosen prior. |
| FG002 | UBMC - Menthol Filtered Little Cigars - Menthol Roll Your Own - Non-menthol Cigarettes | In phase 1, participants first use their usual brand menthol cigarettes, then they try menthol filtered little cigars, followed by menthol roll your own, and non-menthol cigarettes during 4 separate lab visits. In phase 2, participants then substituted the product of their choice for their UBMC for 1 week and completed daily diaries. In phase 3, one final lab visit was conducted with the product chosen prior. |
| FG003 | UBMC - Menthol Filtered Little Cigars - Non-menthol Cigarettes - Menthol Roll Your Own | In phase 1, participants first use their usual brand menthol cigarettes, then they try menthol filtered little cigars, followed by non-menthol cigarettes, and menthol roll your own during 4 separate lab visits. In phase 2, participants then substituted the product of their choice for their UBMC for 1 week and completed daily diaries. In phase 3, one final lab visit was conducted with the product chosen prior. |
| FG004 | UBMC - Non-menthol Cigarettes - Menthol Roll Your Own - Menthol Filtered Little Cigars | In phase 1, participants first use their usual brand menthol cigarettes, then they try non-menthol cigarettes, followed by menthol roll your own, and menthol filtered little cigars during 4 separate lab visits. In phase 2, participants then substituted the product of their choice for their UBMC for 1 week and completed daily diaries. In phase 3, one final lab visit was conducted with the product chosen prior. |
| FG005 | UBMC - Non-menthol Cigarettes - Menthol Filtered Little Cigars - Menthol Roll Your Own | In phase 1, participants first use their usual brand menthol cigarettes, then they try non-menthol cigarettes, followed by menthol filtered little cigars, and menthol roll your own during 4 separate lab visits. In phase 2, participants then substituted the product of their choice for their UBMC for 1 week and completed daily diaries. In phase 3, one final lab visit was conducted with the product chosen prior. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 1 First Smoking Session (2 Hrs) |
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| Phase 1 Second Smoking Session (2 Hrs) |
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| Phase 1 Third Smoking Session (2 Hrs) |
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| Phase 1 Fourth Smoking Session (2 Hrs) |
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| Phase 2 - 1 Week of Daily Diaries |
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| Phase 3 Chosen Product Visit (~3 Hrs) |
|
5 Participants were enrolled in the study but either withdrew or were lost to follow-up prior to baseline demographic measures being recorded
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Population | Full population of participants assessed at baseline. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Puffing Topography: Puff Duration | Average puff duration for each participant, in seconds. | Posted | Mean | Standard Deviation | seconds | Phase 1, Four visits; 20 minute puffing session in total. | Puffs | Puffs |
|
Approximately 1 Month
No difference from clinicaltrials.gov definitions
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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 | Usual Brand Menthol Cigarette (UBMC) | Study participant's usual brand menthol cigarette Menthol cigarettes substitutes: In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability. Menthol cigarettes substitutes and menthol cigarettes: In Phase 3, participants will complete a final in-lab visit to assess the substitutability of their preferred product from Phases 1 and 2, under simulated ban conditions using a progressive ratio task. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neurology/Mood alteration/Depression/Mild mood alteration not interfering with function | Psychiatric disorders | Non-systematic Assessment | Depression - sleeps all day and having weight gain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Theodore L. Wagener | OhioSUCCC | 614-366-4265 | Theodore.Wagener@osumc.edu |
Not provided
| 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 | Mar 31, 2023 | Oct 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
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| NIH |
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| Usual brand menthol cigarettes and substitutes | Behavioral | In Phase 2, to assess uptake, changes in subjective effects, and use over time, participants will select their preferred study product from Phase 1 and be instructed to completely substitute the product for their usual brand menthol cigarette for one week. |
|
| Menthol cigarettes substitutes and menthol cigarettes | Behavioral | In Phase 3, participants will complete a final in-lab visit to assess the substitutability of their preferred product from Phases 1 and 2, under simulated ban conditions using a progressive ratio task. |
|
| Phase 1 - Up to 2 weeks |
| Modified Cigarette Evaluation Questionnaire (mCEQ) | The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective responses to cigarettes (e.g., reward, satisfaction). The 11-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, an craving reduction. | Phase 3 - Approximately 3 hours |
| Cigarette Purchase Task | The Cigarette Purchase Task will ask participants how much they would be willing to pay (ranging from 0 cents to $1) to smoke each product. Given that the study products will look similar to cigarettes, we will retain the original language (e.g., 1 cigarette) in the purchase task. Willingness to spend more will indicate greater abuse liability. Pmax (the price associated with the maximal expenditure, i.e., the highest price before the curve changes from inelastic to elastic), and breakpoint (the last price in which consumption is greater than 0) are reported. | Phase 1 - Up to 2 weeks |
| Cigarette Purchase Task | The Cigarette Purchase Task will ask participants how much they would be willing to pay (ranging from 0 cents to $1) to smoke each product. Given that the study products will look similar to cigarettes, we will retain the original language (e.g., 1 cigarette) in the purchase task. Willingness to spend more will indicate greater abuse liability. Pmax (the price associated with the maximal expenditure, i.e., the highest price before the curve changes from inelastic to elastic), and breakpoint (the last price in which consumption is greater than 0) are reported. | Phase 3 - Approximately 3 hours |
| Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified) | Smoking urges/craving will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form. This is a 10-item measure where participants rate smoking-related items (All I want right now is a cigarette) on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 with higher scores indicating greater craving to smoke. | Phase 1-3 - Up to 3 weeks |
| Minnesota Nicotine Withdrawal Scale | Nicotine withdrawal will be assessed using the empirically validated 15-item version of the Minnesota Nicotine Withdrawal Scale (MNWS). Items were rated on a 5-point scale from 0 (none) to 4 (severe). This measure assesses smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). MNWS is the sum of 7 items with scores ranging from 0 to 28 and MNWS Craving is a single item with scores ranging from 0 to 4, higher scores indicate a greater craving. | Phase 1-3 - Up to 3 weeks |
| Subjective Effects (EMA) | Subjective effects (EMA) of the Phase 2 substitute product will be derived from daily diary EMAs assessing product satisfaction and pleasure. Self-report measure with items rated from 1 (not at all) to 7 (extremely). | Phase 2 - 1 week |
| Cross Price Elasticity Task | A Cross-Price Task in Phases 1 and 3 will estimate substitutability of the study product for the UBMC. Participants will be asked how many study products and UBMCs they would consume when the price of the study product is fixed at $1 and the UBMC prices escalate. The data are then fit to an exponential equation that indicates whether the fixed-price product substitutes for the primary product, and the degree of substitution. Cross price elasticity (CPE) for each study product compared to UBMC > 0.2 indicates substitution, CPE < -0.2 indicates complementarity, and CPE between -0.2 and 0.2 indicate independence of the two products. | Phases 1 - Up to 2 weeks |
| Cross Price Elasticity Task | A Cross-Price Task in Phases 1 and 3 will estimate substitutability of the study product for the UBMC. Participants will be asked how many study products and UBMCs they would consume when the price of the study product is fixed at $1 and the UBMC prices escalate. The data are then fit to an exponential equation that indicates whether the fixed-price product substitutes for the primary product, and the degree of substitution. Cross price elasticity (CPE) for each study product compared to UBMC > 0.2 indicates substitution, CPE < -0.2 indicates complementarity, and CPE between -0.2 and 0.2 indicate independence of the two products. | Phase 3 - Approximately 3 hours |
| Progressive Ratio Task (UBMC vs. Study Product) | The PR task will simulate the effect that restricting menthol in cigarettes would have on increasing (or not) preference for other alternative menthol substitutes. Participants will complete a 90-minute concurrent choice task with different cost (effort) required to earn the reinforcement (2 puffs) from their UBMC and the study product (mFLC or mRYO). Puffs from the study product can be earned by clicking a computer mouse 10 times on a picture of the study product, but to earn two puffs of the UBMC, they will required to make escalating response requirements (computer mouse clicks) according to the following schedule: 10, 160, 320, 640, 1280, 2400, 3600, 4800, 6000, 7200, and 8400. A maximum of 10 reinforcers (20 puffs) per session will be allowed. Participants will be informed of the different sequence between products and instructed that the session are 3 hours in length no matter how much or how little they respond. | Phase 3 - Approximately 3 hours |
| Use Behavior (EMA) | Participants will receive on EMA delivered randomly during the day and an evening daily diary (around 30mins before bedtime). Random EMAs will assess: mood, affect, nicotine craving and withdrawal symptoms, stress, recency of smoking, alcohol use, current setting, and switching self-efficacy; daily diary EMAs will assess UBMC/study product smoked per day, product satisfaction and pleasure. Substitution assessed via use behavior during Phase 2 will be operationalized as the ratio of study product to UBMC used, with a ratio > 0 indicating any substitution and a ratio > 1 indicating substitution of study product for the UBMC at least 50% of the time. | Phase 2 - 1 week |
| Ineligible |
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| COMPLETED |
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| NOT COMPLETED |
|
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| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Menthol Roll Your Own |
|
| Menthol Filtered Little Cigars |
|
| Non-Menthol Cigarettes |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cigarettes Smoked per Day | Mean | Standard Deviation | cigarettes per day |
|
Mentholated pipe tobacco in a roll-your-own cigarette tube Menthol cigarettes substitutes: In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability. Usual brand menthol cigarettes and substitutes: In Phase 2, to assess uptake, changes in subjective effects, and use over time, participants will select their preferred study product from Phase 1 and be instructed to completely substitute the product for their usual brand menthol cigarette for one week. Menthol cigarettes substitutes and menthol cigarettes: In Phase 3, participants will complete a final in-lab visit to assess the substitutability of their preferred product from Phases 1 and 2, under simulated ban conditions using a progressive ratio task. |
| OG002 | Menthol Filtered Little Cigar (mFLC) | The menthol filtered cigar will be Cheyenne (Cheyennecigars.com) Seneca (senecacigars.com) Menthol cigarettes substitutes: In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability. Usual brand menthol cigarettes and substitutes: In Phase 2, to assess uptake, changes in subjective effects, and use over time, participants will select their preferred study product from Phase 1 and be instructed to completely substitute the product for their usual brand menthol cigarette for one week. Menthol cigarettes substitutes and menthol cigarettes: In Phase 3, participants will complete a final in-lab visit to assess the substitutability of their preferred product from Phases 1 and 2, under simulated ban conditions using a progressive ratio task. |
| OG003 | Non-menthol Cigarette (nmC) | The non-menthol cigarette will be Newport non-menthol cigarettes. Menthol cigarettes substitutes: In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability. Usual brand menthol cigarettes and substitutes: In Phase 2, to assess uptake, changes in subjective effects, and use over time, participants will select their preferred study product from Phase 1 and be instructed to completely substitute the product for their usual brand menthol cigarette for one week. Menthol cigarettes substitutes and menthol cigarettes: In Phase 3, participants will complete a final in-lab visit to assess the substitutability of their preferred product from Phases 1 and 2, under simulated ban conditions using a progressive ratio task. |
|
|
| Primary | Puffing Topography: Inter-puff-interval | Inter-puff-interval, the average time between each puff for each participant, in seconds. | Posted | Mean | Standard Deviation | seconds | Phase 1, Four visits; 20 minute puffing session in total. | Puffs | Puffs |
|
|
|
| Primary | Puffing Topography: Puff Flow Rate | Puff flow rate, the average rate of air flow during each puff for each participant, in ml/second. | Posted | Mean | Standard Deviation | ml/second | Phase 1, Four visits; 20 minute puffing session in total. | Puffs | Puffs |
|
|
|
| Primary | Puffing Topography: Total Puff Volume | The total volume of all puffs taken for each participant, in ml. | Posted | Mean | Standard Deviation | ml | Phase 1, Four visits; 20 minute puffing session in total. | Puffs | Puffs |
|
|
|
| Primary | Drug Effects/Liking Questionnaire | An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of UBMC and all three study products, positive and negative effects (i.e., side effects), and perceived strength and effectiveness. Five visual analog scale items ranging from 0 ('not at all') to 100 ('extremely') assessed wanting to smoke the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying. | In the final in-lab visit (Phase 3) only the participants' preferred product was assessed. | Posted | Mean | Standard Deviation | units on a scale | Phases 1 and 3 - Up to 3 weeks |
|
|
|
| Primary | Modified Cigarette Evaluation Questionnaire (mCEQ) | The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective responses to cigarettes (e.g., reward, satisfaction). The 11-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, an craving reduction. | Posted | Mean | Standard Deviation | score on a scale | Phase 1 - Up to 2 weeks |
|
|
|
| Primary | Modified Cigarette Evaluation Questionnaire (mCEQ) | The modified Cigarette Evaluation Questionnaire (mCEQ) will assess subjective responses to cigarettes (e.g., reward, satisfaction). The 11-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 1 (not at all) to 7 (extremely likely). Items are averaged to create each of the subscales also ranging from 1 to 7 with higher values indicating greater levels of smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations, an craving reduction. | Posted | Mean | Standard Deviation | score on a scale | Phase 3 - Approximately 3 hours |
|
|
|
| Primary | Cigarette Purchase Task | The Cigarette Purchase Task will ask participants how much they would be willing to pay (ranging from 0 cents to $1) to smoke each product. Given that the study products will look similar to cigarettes, we will retain the original language (e.g., 1 cigarette) in the purchase task. Willingness to spend more will indicate greater abuse liability. Pmax (the price associated with the maximal expenditure, i.e., the highest price before the curve changes from inelastic to elastic), and breakpoint (the last price in which consumption is greater than 0) are reported. | Posted | Mean | 95% Confidence Interval | Dollars | Phase 1 - Up to 2 weeks |
|
|
|
| Primary | Cigarette Purchase Task | The Cigarette Purchase Task will ask participants how much they would be willing to pay (ranging from 0 cents to $1) to smoke each product. Given that the study products will look similar to cigarettes, we will retain the original language (e.g., 1 cigarette) in the purchase task. Willingness to spend more will indicate greater abuse liability. Pmax (the price associated with the maximal expenditure, i.e., the highest price before the curve changes from inelastic to elastic), and breakpoint (the last price in which consumption is greater than 0) are reported. | Posted | Mean | 95% Confidence Interval | Dollars | Phase 3 - Approximately 3 hours |
|
|
|
| Primary | Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified) | Smoking urges/craving will be measured using the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form. This is a 10-item measure where participants rate smoking-related items (All I want right now is a cigarette) on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 with higher scores indicating greater craving to smoke. | In phases 2 and 3 only the participants' preferred product was assessed. | Posted | Mean | Standard Deviation | score on a scale | Phase 1-3 - Up to 3 weeks |
|
|
|
| Primary | Minnesota Nicotine Withdrawal Scale | Nicotine withdrawal will be assessed using the empirically validated 15-item version of the Minnesota Nicotine Withdrawal Scale (MNWS). Items were rated on a 5-point scale from 0 (none) to 4 (severe). This measure assesses smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). MNWS is the sum of 7 items with scores ranging from 0 to 28 and MNWS Craving is a single item with scores ranging from 0 to 4, higher scores indicate a greater craving. | In phases 2 and 3 only the participants' preferred product was assessed. | Posted | Mean | Standard Deviation | score on a scale | Phase 1-3 - Up to 3 weeks |
|
|
|
| Primary | Subjective Effects (EMA) | Subjective effects (EMA) of the Phase 2 substitute product will be derived from daily diary EMAs assessing product satisfaction and pleasure. Self-report measure with items rated from 1 (not at all) to 7 (extremely). | Posted | Mean | Standard Deviation | score on a scale | Phase 2 - 1 week |
|
|
|
| Primary | Cross Price Elasticity Task | A Cross-Price Task in Phases 1 and 3 will estimate substitutability of the study product for the UBMC. Participants will be asked how many study products and UBMCs they would consume when the price of the study product is fixed at $1 and the UBMC prices escalate. The data are then fit to an exponential equation that indicates whether the fixed-price product substitutes for the primary product, and the degree of substitution. Cross price elasticity (CPE) for each study product compared to UBMC > 0.2 indicates substitution, CPE < -0.2 indicates complementarity, and CPE between -0.2 and 0.2 indicate independence of the two products. | Posted | Mean | 95% Confidence Interval | slope | Phases 1 - Up to 2 weeks |
|
|
|
| Primary | Cross Price Elasticity Task | A Cross-Price Task in Phases 1 and 3 will estimate substitutability of the study product for the UBMC. Participants will be asked how many study products and UBMCs they would consume when the price of the study product is fixed at $1 and the UBMC prices escalate. The data are then fit to an exponential equation that indicates whether the fixed-price product substitutes for the primary product, and the degree of substitution. Cross price elasticity (CPE) for each study product compared to UBMC > 0.2 indicates substitution, CPE < -0.2 indicates complementarity, and CPE between -0.2 and 0.2 indicate independence of the two products. | Posted | Mean | 95% Confidence Interval | slope | Phase 3 - Approximately 3 hours |
|
|
|
| Primary | Progressive Ratio Task (UBMC vs. Study Product) | The PR task will simulate the effect that restricting menthol in cigarettes would have on increasing (or not) preference for other alternative menthol substitutes. Participants will complete a 90-minute concurrent choice task with different cost (effort) required to earn the reinforcement (2 puffs) from their UBMC and the study product (mFLC or mRYO). Puffs from the study product can be earned by clicking a computer mouse 10 times on a picture of the study product, but to earn two puffs of the UBMC, they will required to make escalating response requirements (computer mouse clicks) according to the following schedule: 10, 160, 320, 640, 1280, 2400, 3600, 4800, 6000, 7200, and 8400. A maximum of 10 reinforcers (20 puffs) per session will be allowed. Participants will be informed of the different sequence between products and instructed that the session are 3 hours in length no matter how much or how little they respond. | Posted | Mean | Standard Deviation | Number of Puffs on UBMC | Phase 3 - Approximately 3 hours |
|
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| Primary | Use Behavior (EMA) | Participants will receive on EMA delivered randomly during the day and an evening daily diary (around 30mins before bedtime). Random EMAs will assess: mood, affect, nicotine craving and withdrawal symptoms, stress, recency of smoking, alcohol use, current setting, and switching self-efficacy; daily diary EMAs will assess UBMC/study product smoked per day, product satisfaction and pleasure. Substitution assessed via use behavior during Phase 2 will be operationalized as the ratio of study product to UBMC used, with a ratio > 0 indicating any substitution and a ratio > 1 indicating substitution of study product for the UBMC at least 50% of the time. | Posted | Count of Participants | Participants | Phase 2 - 1 week |
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| 0 |
| 98 |
| 0 |
| 98 |
| 6 |
| 98 |
| EG001 | Menthol Roll-your-own Cigarette (mRYO) | Mentholated pipe tobacco in a roll-your-own cigarette tube Menthol cigarettes substitutes: In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability. Usual brand menthol cigarettes and substitutes: In Phase 2, to assess uptake, changes in subjective effects, and use over time, participants will select their preferred study product from Phase 1 and be instructed to completely substitute the product for their usual brand menthol cigarette for one week. Menthol cigarettes substitutes and menthol cigarettes: In Phase 3, participants will complete a final in-lab visit to assess the substitutability of their preferred product from Phases 1 and 2, under simulated ban conditions using a progressive ratio task. | 0 | 84 | 0 | 84 | 4 | 84 |
| EG002 | Menthol Filtered Little Cigar (mFLC) | The menthol filtered cigar will be Cheyenne (Cheyennecigars.com) Seneca (senecacigars.com) Menthol cigarettes substitutes: In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability. Usual brand menthol cigarettes and substitutes: In Phase 2, to assess uptake, changes in subjective effects, and use over time, participants will select their preferred study product from Phase 1 and be instructed to completely substitute the product for their usual brand menthol cigarette for one week. Menthol cigarettes substitutes and menthol cigarettes: In Phase 3, participants will complete a final in-lab visit to assess the substitutability of their preferred product from Phases 1 and 2, under simulated ban conditions using a progressive ratio task. | 0 | 82 | 0 | 82 | 3 | 82 |
| EG003 | Non-menthol Cigarette (nmC) | The non-menthol cigarette will be Newport non-menthol cigarettes. Menthol cigarettes substitutes: In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability. Usual brand menthol cigarettes and substitutes: In Phase 2, to assess uptake, changes in subjective effects, and use over time, participants will select their preferred study product from Phase 1 and be instructed to completely substitute the product for their usual brand menthol cigarette for one week. Menthol cigarettes substitutes and menthol cigarettes: In Phase 3, participants will complete a final in-lab visit to assess the substitutability of their preferred product from Phases 1 and 2, under simulated ban conditions using a progressive ratio task. | 0 | 83 | 0 | 83 | 2 | 83 |
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| Neurology/Mood alteration/Depression/Mild mood alteration not interfering with function | Psychiatric disorders | Non-systematic Assessment | Depression, Anxiety, and Obsessive Compulsive Disorder |
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| Surgery/cyst removed | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Surgery to remove cyst in right hand |
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| Pulmonary/Upper Respiratory - Smoker's Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Smoker's Cough - gets winded easily and feels like lung capacity is low |
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| Neurology/Confusion/Transient Confusion, disorientation or attention deficit | Psychiatric disorders | Non-systematic Assessment | ADHD - Attention Deficit Hyperactivity Disorder |
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| Neurology/Mood alteration/Depression/Mild mood alteration not interfering with function | Psychiatric disorders | Non-systematic Assessment | Generalized anxiety and depression |
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| Allergy/Immunology/Autoimmune reaction/Immune System Disorders | Immune system disorders | Non-systematic Assessment | Participant has chronic fatigue, pain, vertigo, and migraine associated with an autoimmune disorder |
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| Neurology/Mood alteration/Depression/Mild mood alteration not interfering with function | Psychiatric disorders | Non-systematic Assessment | General anxiety |
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| Surgery/Intraoperative Injury/Gallbladder removed | Gastrointestinal disorders | Non-systematic Assessment | Had gallbladder removed due to having gall stones |
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| Neurology/Mood alteration/Depression/Mild mood alteration not interfering with function | Psychiatric disorders | Non-systematic Assessment | Anxious, impatient, lost, depressed (not diagnosed); feels like this because of husband's health, her job, and her menstrual cycles; has felt this way for years, but more serious now because of husband's surgery; planning to see company counselor |
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| Neurology/Mood alteration/Depression/Mild mood alteration not interfering with function | Psychiatric disorders | Non-systematic Assessment | Feeling depressed |
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| Neurology/Mood alteration/Depression/Mild mood alteration not interfering with function | Psychiatric disorders | Non-systematic Assessment | Dizzy brain fog; started after stopped using study product (stopped Sunday; started having symptoms late Monday); unsure of dizzy brain fog cause because she is having trouble wearing a mask (COVID) which makes her dizzy and has been travelling |
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| Neurology/Mood alteration/Depression/Mild mood alteration not interfering with function | Psychiatric disorders | Non-systematic Assessment | Depression and anxiety high; had two deaths in her family on the same day |
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| Dermatology/Skin - Other | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Psoriasis flare-up |
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| Neurology/Mood alteration/Depression/Mild mood alteration not interfering with function | Psychiatric disorders | Non-systematic Assessment | Depression due to difficulties with ex-husband |
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| Neurology/Mood alteration/Depression/Mild mood alteration not interfering with function | Psychiatric disorders | Non-systematic Assessment | Feeling moderately depressed; has been taking meds for the last 15 years to control anxiety and depression; has seen doctors and counselors; broke up with her boyfriend and is sad; said depression was not unmanageable |
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| Neurology/Mood alteration/Depression/Mild mood alteration not interfering with function | Psychiatric disorders | Non-systematic Assessment | Depression because of aunt being in the hospital with COVID |
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| Like (Phase 1) |
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| Desire (5 Minutes; Phase 1) |
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