Smoking (Tobacco) AddictionMENTHOLNCT04844762
Addiction and Behavior Related to Menthol Cigarette Substitutes
A study testing Menthol cigarettes substitutes, Usual brand menthol cigarettes and substitutes and Menthol cigarettes substitutes and menthol cigarettes in people with Smoking (Tobacco) Addiction, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking (Tobacco) Addiction
- What is being tested?
- Menthol cigarettes substitutes, Usual brand menthol cigarettes and substitutes and Menthol cigarettes substitutes and menthol cigarettes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2019to 9 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- current menthol cigarette smoker (>90% menthol cigarette use; ≥5 cigarettes per day) for at least the past 6 months.
- between 18-24 (young adult) or 25-50 years old (aged 25+)
- willing to provide informed consent and abstain from all tobacco and nicotine use for at least 12 hours prior to the five lab sessions
- willing to complete one week of EMA
- read and speak English.
Who cannot join
- self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
- unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- history of cardiac event or distress within the past 3 months
- currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test)
- use of other tobacco products (e.g., e-cig, cigar, etc.) >5 days in the past month
- current marijuana use >5 times per month
Show all 9Show fewer
- any use of other illicit drugs during the last 30 days (verified by urinalysis at initial visit)
- currently engaging in a smoking cessation attempt
- currently using one of the alternative menthol study products
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43214
About this study
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.
Read the detailed description
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.
- Conditions
- Smoking (Tobacco) Addiction
- Being tested
- Menthol cigarettes substitutes, Usual brand menthol cigarettes and substitutes, Menthol cigarettes substitutes and menthol cigarettes
- Keywords
- Menthol cigarettes
- Medical subject headings
- Smoking, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menthol cigarettes substitutesBehavioural
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 substitutesBehavioural
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 cigarettesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| usual brand menthol cigarette (UBMC) | Active comparator | Study participant's usual brand menthol cigarette Receives: Behavioral: Menthol cigarettes substitutes; Behavioral: Menthol cigarettes substitutes and menthol cigarettes |
| menthol roll-your-own cigarette (mRYO) | Active comparator | Mentholated pipe tobacco in a roll-your-own cigarette tube Receives: Behavioral: Menthol cigarettes substitutes; Behavioral: Usual brand menthol cigarettes and substitutes; Behavioral: Menthol cigarettes substitutes and menthol cigarettes |
| menthol filtered little cigar (mFLC) | Active comparator | The menthol filtered cigar will be Cheyenne (Cheyennecigars.com) Seneca (senecacigars.com) Receives: Behavioral: Menthol cigarettes substitutes; Behavioral: Usual brand menthol cigarettes and substitutes; Behavioral: Menthol cigarettes substitutes and menthol cigarettes |
| non-menthol cigarette (nmC) | Active comparator | The non-menthol cigarette will be Newport non-menthol cigarettes. Receives: Behavioral: Menthol cigarettes substitutes; Behavioral: Usual brand menthol cigarettes and substitutes; Behavioral: Menthol cigarettes substitutes and menthol cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Puffing Topography: Puff Duration
Average puff duration for each participant, in seconds.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Phase 2 - 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start16 Dec 2019
- Primary completion9 Aug 2021
- Study completion9 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking (Tobacco) AddictionStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vermont, Brown University, National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Theodore Wagener, Ohio State University Comprehensive Cancer Center
- Investigators
- Theodore Wagener, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844762
- Sponsor's protocol ID
- OSU-19145
- Other IDs
- 1R21DA046333-01A1
- Acronym
- MENTHOL
- Status last verified
- Feb 2024
- First submitted
- 2 Jul 2020
- Last updated
- 9 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37963771
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addiction and Behavior Related to Menthol Cigarette Substitutes
- ClinicalTrials.gov ID
- NCT04844762
- Acronym / sponsor ID
- MENTHOL / OSU-19145
- Conditions
- Smoking (Tobacco) Addiction
- Keywords
- Menthol cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- University of Vermont, Brown University, National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 14 Apr 2021 (actual)
- Results
- Posted 9 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| usual brand menthol cigarette (UBMC) | Active comparator | Behavioral: Menthol cigarettes substitutes, Behavioral: Menthol cigarettes substitutes and menthol cigarettesStudy participant's usual brand menthol cigarette |
| menthol roll-your-own cigarette (mRYO) | Active comparator | Behavioral: Menthol cigarettes substitutes, Behavioral: Usual brand menthol cigarettes and substitutes, Behavioral: Menthol cigarettes substitutes and menthol cigarettesMentholated pipe tobacco in a roll-your-own cigarette tube |
| menthol filtered little cigar (mFLC) | Active comparator | Behavioral: Menthol cigarettes substitutes, Behavioral: Usual brand menthol cigarettes and substitutes, Behavioral: Menthol cigarettes substitutes and menthol cigarettesThe menthol filtered cigar will be Cheyenne (Cheyennecigars.com) Seneca (senecacigars.com) |
| non-menthol cigarette (nmC) | Active comparator | Behavioral: Menthol cigarettes substitutes, Behavioral: Usual brand menthol cigarettes and substitutes, Behavioral: Menthol cigarettes substitutes and menthol cigarettesThe non-menthol cigarette will be Newport non-menthol cigarettes. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- current menthol cigarette smoker (>90% menthol cigarette use; ≥5 cigarettes per day) for at least the past 6 months.
- between 18-24 (young adult) or 25-50 years old (aged 25+)
- willing to provide informed consent and abstain from all tobacco and nicotine use for at least 12 hours prior to the five lab sessions
- willing to complete one week of EMA
- read and speak English.
Key exclusion criteria (9 listed)
- self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
- unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- history of cardiac event or distress within the past 3 months
- currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test)
- use of other tobacco products (e.g., e-cig, cigar, etc.) >5 days in the past month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menthol cigarettes substitutesIn Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability. | Behavioural | menthol filtered little cigar (mFLC), menthol roll-your-own cigarette (mRYO), non-menthol cigarette (nmC), usual brand menthol cigarette (UBMC) |
| Usual brand menthol cigarettes and substitutesIn 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. | Behavioural | menthol filtered little cigar (mFLC), menthol roll-your-own cigarette (mRYO), non-menthol cigarette (nmC) |
| Menthol cigarettes substitutes and menthol cigarettesIn 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. | Behavioural | menthol filtered little cigar (mFLC), menthol roll-your-own cigarette (mRYO), non-menthol cigarette (nmC), usual brand menthol cigarette (UBMC) |
Primary outcome
Puffing Topography: Puff Duration
Time frame: Phase 1, Four visits; 20 minute puffing session in total.
Average puff duration for each participant, in seconds.
Puffing Topography: Inter-puff-interval
Time frame: Phase 1, Four visits; 20 minute puffing session in total.
Inter-puff-interval, the average time between each puff for each participant, in seconds.
Puffing Topography: Puff Flow Rate
Time frame: Phase 1, Four visits; 20 minute puffing session in total.
Puff flow rate, the average rate of air flow during each puff for each participant, in ml/second.
Puffing Topography: Total Puff Volume
Time frame: Phase 1, Four visits; 20 minute puffing session in total.
The total volume of all puffs taken for each participant, in ml.
Drug Effects/Liking Questionnaire
Time frame: Phases 1 and 3 - Up to 3 weeks
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.
Modified Cigarette Evaluation Questionnaire (mCEQ)
Time frame: Phase 1 - Up to 2 weeks
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.
Modified Cigarette Evaluation Questionnaire (mCEQ)
Time frame: Phase 3 - Approximately 3 hours
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.
Cigarette Purchase Task
Time frame: Phase 1 - Up to 2 weeks
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.
Cigarette Purchase Task
Time frame: Phase 3 - Approximately 3 hours
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.
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Time frame: Phase 1-3 - Up to 3 weeks
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.
Minnesota Nicotine Withdrawal Scale
Time frame: Phase 1-3 - Up to 3 weeks
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.
Subjective Effects (EMA)
Time frame: Phase 2 - 1 week
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).
Cross Price Elasticity Task
Time frame: Phases 1 - Up to 2 weeks
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.
Cross Price Elasticity Task
Time frame: Phase 3 - Approximately 3 hours
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.
Progressive Ratio Task (UBMC vs. Study Product)
Time frame: Phase 3 - Approximately 3 hours
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.
Use Behavior (EMA)
Time frame: Phase 2 - 1 week
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37963771Villanti 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.
- JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore Wagener, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menthol cigarettes substitutes, Usual brand menthol cigarettes and substitutes and Menthol cigarettes substitutes and menthol cigarettes in people with Smoking (Tobacco) Addiction, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Puffing Topography: Puff Duration (time frame: Phase 1, Four visits; 20 minute puffing session in total.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04844762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.