Trial Outcomes & Findings for Addiction and Behavior Related to Menthol Cigarette Substitutes (NCT NCT04844762)
NCT ID: NCT04844762
Last Updated: 2024-02-09
Results Overview
Average puff duration for each participant, in seconds.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Phase 1, Four visits; 20 minute puffing session in total.
Results posted on
2024-02-09
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Phase 1 First Smoking Session (2 Hrs)
STARTED
|
17
|
17
|
17
|
18
|
17
|
17
|
|
Phase 1 First Smoking Session (2 Hrs)
COMPLETED
|
17
|
16
|
15
|
17
|
17
|
16
|
|
Phase 1 First Smoking Session (2 Hrs)
NOT COMPLETED
|
0
|
1
|
2
|
1
|
0
|
1
|
|
Phase 1 Second Smoking Session (2 Hrs)
STARTED
|
17
|
16
|
15
|
17
|
17
|
16
|
|
Phase 1 Second Smoking Session (2 Hrs)
COMPLETED
|
16
|
14
|
13
|
13
|
15
|
15
|
|
Phase 1 Second Smoking Session (2 Hrs)
NOT COMPLETED
|
1
|
2
|
2
|
4
|
2
|
1
|
|
Phase 1 Third Smoking Session (2 Hrs)
STARTED
|
16
|
14
|
13
|
13
|
15
|
15
|
|
Phase 1 Third Smoking Session (2 Hrs)
COMPLETED
|
14
|
14
|
13
|
13
|
14
|
15
|
|
Phase 1 Third Smoking Session (2 Hrs)
NOT COMPLETED
|
2
|
0
|
0
|
0
|
1
|
0
|
|
Phase 1 Fourth Smoking Session (2 Hrs)
STARTED
|
14
|
14
|
13
|
13
|
14
|
15
|
|
Phase 1 Fourth Smoking Session (2 Hrs)
COMPLETED
|
13
|
13
|
13
|
13
|
14
|
14
|
|
Phase 1 Fourth Smoking Session (2 Hrs)
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
1
|
|
Phase 2 - 1 Week of Daily Diaries
STARTED
|
13
|
13
|
13
|
13
|
14
|
14
|
|
Phase 2 - 1 Week of Daily Diaries
Menthol Roll Your Own
|
9
|
9
|
9
|
8
|
7
|
10
|
|
Phase 2 - 1 Week of Daily Diaries
Menthol Filtered Little Cigars
|
1
|
2
|
1
|
3
|
2
|
1
|
|
Phase 2 - 1 Week of Daily Diaries
Non-Menthol Cigarettes
|
3
|
2
|
3
|
2
|
5
|
3
|
|
Phase 2 - 1 Week of Daily Diaries
COMPLETED
|
13
|
13
|
13
|
13
|
14
|
14
|
|
Phase 2 - 1 Week of Daily Diaries
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 3 Chosen Product Visit (~3 Hrs)
STARTED
|
13
|
13
|
13
|
13
|
14
|
14
|
|
Phase 3 Chosen Product Visit (~3 Hrs)
COMPLETED
|
13
|
13
|
13
|
12
|
14
|
14
|
|
Phase 3 Chosen Product Visit (~3 Hrs)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Phase 1 First Smoking Session (2 Hrs)
Lost to Follow-up
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Phase 1 First Smoking Session (2 Hrs)
Ineligible
|
0
|
1
|
0
|
1
|
0
|
1
|
|
Phase 1 Second Smoking Session (2 Hrs)
Withdrawal by Subject
|
0
|
0
|
1
|
3
|
0
|
1
|
|
Phase 1 Second Smoking Session (2 Hrs)
Lost to Follow-up
|
0
|
0
|
1
|
1
|
2
|
0
|
|
Phase 1 Second Smoking Session (2 Hrs)
Withdrawal by Study Team
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Phase 1 Third Smoking Session (2 Hrs)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Third Smoking Session (2 Hrs)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Phase 1 Third Smoking Session (2 Hrs)
Withdrawal by Study Team
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1 Fourth Smoking Session (2 Hrs)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Phase 1 Fourth Smoking Session (2 Hrs)
Ineligible
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Phase 3 Chosen Product Visit (~3 Hrs)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Addiction and Behavior Related to Menthol Cigarette Substitutes
Baseline characteristics by cohort
| Measure |
Overall Population
n=98 Participants
Full population of participants assessed at baseline.
|
|---|---|
|
Age, Continuous
|
37.04 years
STANDARD_DEVIATION 7.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
|
Cigarettes Smoked per Day
|
11.90 cigarettes per day
STANDARD_DEVIATION 5.49 • n=5 Participants
|
PRIMARY outcome
Timeframe: Phase 1, Four visits; 20 minute puffing session in total.Average puff duration for each participant, in seconds.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=991 Puffs
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=846 Puffs
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.
|
Menthol Filtered Little Cigar (mFLC)
n=848 Puffs
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.
|
Non-menthol Cigarette (nmC)
n=832 Puffs
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.
|
|---|---|---|---|---|
|
Puffing Topography: Puff Duration
|
1.99 seconds
Standard Deviation 0.56
|
2.06 seconds
Standard Deviation 0.65
|
2.66 seconds
Standard Deviation 0.95
|
1.87 seconds
Standard Deviation 0.61
|
PRIMARY outcome
Timeframe: Phase 1, Four visits; 20 minute puffing session in total.Inter-puff-interval, the average time between each puff for each participant, in seconds.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=991 Puffs
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=846 Puffs
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.
|
Menthol Filtered Little Cigar (mFLC)
n=848 Puffs
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.
|
Non-menthol Cigarette (nmC)
n=832 Puffs
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.
|
|---|---|---|---|---|
|
Puffing Topography: Inter-puff-interval
|
27.55 seconds
Standard Deviation 1.73
|
27.54 seconds
Standard Deviation 1.22
|
26.25 seconds
Standard Deviation 3.04
|
27.79 seconds
Standard Deviation 1.61
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=991 Puffs
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=846 Puffs
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.
|
Menthol Filtered Little Cigar (mFLC)
n=848 Puffs
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.
|
Non-menthol Cigarette (nmC)
n=832 Puffs
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.
|
|---|---|---|---|---|
|
Puffing Topography: Puff Flow Rate
|
23.75 ml/second
Standard Deviation 7.02
|
24.95 ml/second
Standard Deviation 7.66
|
16.97 ml/second
Standard Deviation 5.43
|
22.12 ml/second
Standard Deviation 7.46
|
PRIMARY outcome
Timeframe: Phase 1, Four visits; 20 minute puffing session in total.The total volume of all puffs taken for each participant, in ml.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=991 Puffs
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=846 Puffs
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.
|
Menthol Filtered Little Cigar (mFLC)
n=848 Puffs
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.
|
Non-menthol Cigarette (nmC)
n=832 Puffs
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.
|
|---|---|---|---|---|
|
Puffing Topography: Total Puff Volume
|
462.92 ml
Standard Deviation 141.00
|
485.68 ml
Standard Deviation 126.65
|
434.66 ml
Standard Deviation 127.95
|
391.24 ml
Standard Deviation 129.93
|
PRIMARY outcome
Timeframe: Phases 1 and 3 - Up to 3 weeksPopulation: In the final in-lab visit (Phase 3) only the participants' preferred product was assessed.
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.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=98 Participants
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=84 Participants
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.
|
Menthol Filtered Little Cigar (mFLC)
n=82 Participants
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.
|
Non-menthol Cigarette (nmC)
n=83 Participants
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.
|
|---|---|---|---|---|
|
Drug Effects/Liking Questionnaire
Like (Phase 1)
|
96.02 units on a scale
Standard Deviation 8.73
|
59.36 units on a scale
Standard Deviation 30.89
|
27.93 units on a scale
Standard Deviation 28.84
|
30.95 units on a scale
Standard Deviation 32.10
|
|
Drug Effects/Liking Questionnaire
Want (Phase 3)
|
—
|
44.90 units on a scale
Standard Deviation 30.52
|
36.80 units on a scale
Standard Deviation 38.80
|
44.44 units on a scale
Standard Deviation 33.64
|
|
Drug Effects/Liking Questionnaire
Want (Phase 1)
|
91.49 units on a scale
Standard Deviation 19.09
|
56.68 units on a scale
Standard Deviation 29.42
|
26.72 units on a scale
Standard Deviation 28.30
|
30.35 units on a scale
Standard Deviation 31.74
|
|
Drug Effects/Liking Questionnaire
Enjoy (Phase 1)
|
95.02 units on a scale
Standard Deviation 11.35
|
57.75 units on a scale
Standard Deviation 31.61
|
28.78 units on a scale
Standard Deviation 29.31
|
31.58 units on a scale
Standard Deviation 32.62
|
|
Drug Effects/Liking Questionnaire
Pleasurable (Phase 1)
|
94.65 units on a scale
Standard Deviation 10.96
|
57.92 units on a scale
Standard Deviation 32.79
|
27.65 units on a scale
Standard Deviation 29.54
|
32.16 units on a scale
Standard Deviation 32.94
|
|
Drug Effects/Liking Questionnaire
Satisfying (Phase 1)
|
96.09 units on a scale
Standard Deviation 8.00
|
60.70 units on a scale
Standard Deviation 32.30
|
28.67 units on a scale
Standard Deviation 28.49
|
35.17 units on a scale
Standard Deviation 33.04
|
|
Drug Effects/Liking Questionnaire
Like (Phase 3)
|
—
|
54.39 units on a scale
Standard Deviation 32.07
|
52.50 units on a scale
Standard Deviation 35.16
|
51.11 units on a scale
Standard Deviation 30.12
|
|
Drug Effects/Liking Questionnaire
Enjoy (Phase 3)
|
—
|
53.33 units on a scale
Standard Deviation 31.45
|
47.30 units on a scale
Standard Deviation 38.39
|
50.44 units on a scale
Standard Deviation 30.62
|
|
Drug Effects/Liking Questionnaire
Pleasurable (Phase 3)
|
—
|
52.18 units on a scale
Standard Deviation 32.09
|
44.20 units on a scale
Standard Deviation 40.75
|
49.00 units on a scale
Standard Deviation 31.52
|
|
Drug Effects/Liking Questionnaire
Satisfying (Phase 3)
|
—
|
57.55 units on a scale
Standard Deviation 31.65
|
51.80 units on a scale
Standard Deviation 40.56
|
57.06 units on a scale
Standard Deviation 29.97
|
PRIMARY outcome
Timeframe: Phase 1 - Up to 2 weeksThe 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.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=98 Participants
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=84 Participants
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.
|
Menthol Filtered Little Cigar (mFLC)
n=82 Participants
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.
|
Non-menthol Cigarette (nmC)
n=83 Participants
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.
|
|---|---|---|---|---|
|
Modified Cigarette Evaluation Questionnaire (mCEQ)
Smoking Satisfaction
|
5.79 score on a scale
Standard Deviation 1.12
|
4.06 score on a scale
Standard Deviation 1.70
|
2.43 score on a scale
Standard Deviation 1.32
|
2.59 score on a scale
Standard Deviation 1.61
|
|
Modified Cigarette Evaluation Questionnaire (mCEQ)
Aversion
|
2.23 score on a scale
Standard Deviation 1.04
|
1.98 score on a scale
Standard Deviation 1.14
|
1.66 score on a scale
Standard Deviation 1.22
|
2.45 score on a scale
Standard Deviation 1.29
|
|
Modified Cigarette Evaluation Questionnaire (mCEQ)
Enjoyment of Respiratory Tract Sensations
|
5.18 score on a scale
Standard Deviation 1.43
|
3.80 score on a scale
Standard Deviation 1.85
|
2.21 score on a scale
Standard Deviation 1.50
|
2.59 score on a scale
Standard Deviation 1.64
|
|
Modified Cigarette Evaluation Questionnaire (mCEQ)
Psychological Reward
|
3.97 score on a scale
Standard Deviation 1.45
|
2.85 score on a scale
Standard Deviation 1.49
|
2.03 score on a scale
Standard Deviation 1.25
|
2.54 score on a scale
Standard Deviation 1.43
|
|
Modified Cigarette Evaluation Questionnaire (mCEQ)
Craving Reduction
|
5.12 score on a scale
Standard Deviation 1.66
|
4.63 score on a scale
Standard Deviation 1.70
|
3.02 score on a scale
Standard Deviation 1.71
|
3.83 score on a scale
Standard Deviation 1.79
|
PRIMARY outcome
Timeframe: Phase 3 - Approximately 3 hoursThe 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.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=51 Participants
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=10 Participants
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.
|
Menthol Filtered Little Cigar (mFLC)
n=18 Participants
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.
|
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.
|
|---|---|---|---|---|
|
Modified Cigarette Evaluation Questionnaire (mCEQ)
Smoking Satisfaction
|
3.89 score on a scale
Standard Deviation 1.74
|
3.43 score on a scale
Standard Deviation 1.94
|
3.52 score on a scale
Standard Deviation 1.83
|
—
|
|
Modified Cigarette Evaluation Questionnaire (mCEQ)
Psychological Reward
|
2.90 score on a scale
Standard Deviation 1.66
|
2.26 score on a scale
Standard Deviation 1.84
|
2.58 score on a scale
Standard Deviation 1.38
|
—
|
|
Modified Cigarette Evaluation Questionnaire (mCEQ)
Aversion
|
1.62 score on a scale
Standard Deviation 1.23
|
1.15 score on a scale
Standard Deviation 0.24
|
1.67 score on a scale
Standard Deviation 1.22
|
—
|
|
Modified Cigarette Evaluation Questionnaire (mCEQ)
Enjoyment of Respiratory Tract Sensations
|
3.63 score on a scale
Standard Deviation 1.88
|
2.70 score on a scale
Standard Deviation 2.16
|
3.17 score on a scale
Standard Deviation 1.69
|
—
|
|
Modified Cigarette Evaluation Questionnaire (mCEQ)
Craving Reduction
|
4.31 score on a scale
Standard Deviation 1.73
|
3.80 score on a scale
Standard Deviation 1.93
|
4.06 score on a scale
Standard Deviation 1.76
|
—
|
PRIMARY outcome
Timeframe: Phase 1 - Up to 2 weeksThe 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.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=98 Participants
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=84 Participants
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.
|
Menthol Filtered Little Cigar (mFLC)
n=82 Participants
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.
|
Non-menthol Cigarette (nmC)
n=83 Participants
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.
|
|---|---|---|---|---|
|
Cigarette Purchase Task
Pmax
|
2.03 Dollars
Interval 1.56 to 2.49
|
1.64 Dollars
Interval 1.23 to 2.05
|
1.63 Dollars
Interval 0.88 to 2.37
|
1.57 Dollars
Interval 1.01 to 2.13
|
|
Cigarette Purchase Task
Breakpoint
|
6.12 Dollars
Interval 4.35 to 7.9
|
4.30 Dollars
Interval 2.76 to 5.78
|
2.82 Dollars
Interval 1.53 to 4.11
|
3.15 Dollars
Interval 1.93 to 4.36
|
PRIMARY outcome
Timeframe: Phase 3 - Approximately 3 hoursThe 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.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=49 Participants
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=9 Participants
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.
|
Menthol Filtered Little Cigar (mFLC)
n=17 Participants
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.
|
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.
|
|---|---|---|---|---|
|
Cigarette Purchase Task
Pmax
|
1.62 Dollars
Interval 1.21 to 2.03
|
1.11 Dollars
Interval 0.03 to 2.2
|
1.03 Dollars
Interval 0.54 to 1.52
|
—
|
|
Cigarette Purchase Task
Breakpoint
|
3.36 Dollars
Interval 2.18 to 4.55
|
4.51 Dollars
Interval -2.95 to 11.97
|
2.69 Dollars
Interval 1.04 to 4.33
|
—
|
PRIMARY outcome
Timeframe: Phase 1-3 - Up to 3 weeksPopulation: In phases 2 and 3 only the participants' preferred product was assessed.
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.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=98 Participants
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=84 Participants
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.
|
Menthol Filtered Little Cigar (mFLC)
n=82 Participants
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.
|
Non-menthol Cigarette (nmC)
n=83 Participants
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.
|
|---|---|---|---|---|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Desire (0 Minutes; Phase 1)
|
30.24 score on a scale
Standard Deviation 5.93
|
29.63 score on a scale
Standard Deviation 7.04
|
29.77 score on a scale
Standard Deviation 7.19
|
29.77 score on a scale
Standard Deviation 7.08
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Desire (15 Minutes; Phase 1)
|
14.90 score on a scale
Standard Deviation 8.82
|
14.31 score on a scale
Standard Deviation 9.02
|
17.71 score on a scale
Standard Deviation 9.08
|
14.60 score on a scale
Standard Deviation 8.60
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Desire (30 Minutes; Phase 1)
|
17.00 score on a scale
Standard Deviation 9.43
|
16.50 score on a scale
Standard Deviation 9.24
|
19.96 score on a scale
Standard Deviation 9.56
|
17.23 score on a scale
Standard Deviation 9.25
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Desire (60 Minutes; Phase 1)
|
19.92 score on a scale
Standard Deviation 9.33
|
20.17 score on a scale
Standard Deviation 9.41
|
22.38 score on a scale
Standard Deviation 9.84
|
20.51 score on a scale
Standard Deviation 9.71
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Desire (90 Minutes; Phase 1)
|
22.92 score on a scale
Standard Deviation 9.06
|
23.23 score on a scale
Standard Deviation 9.22
|
24.85 score on a scale
Standard Deviation 9.39
|
23.27 score on a scale
Standard Deviation 9.49
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Relief (0 Minutes; Phase 1)
|
18.00 score on a scale
Standard Deviation 7.30
|
18.65 score on a scale
Standard Deviation 8.99
|
17.84 score on a scale
Standard Deviation 8.89
|
18.23 score on a scale
Standard Deviation 9.32
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Relief (5 Minutes; Phase 1)
|
8.24 score on a scale
Standard Deviation 4.78
|
7.82 score on a scale
Standard Deviation 4.66
|
9.48 score on a scale
Standard Deviation 5.59
|
7.83 score on a scale
Standard Deviation 4.43
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Relief (15 Minutes; Phase 1)
|
8.52 score on a scale
Standard Deviation 5.04
|
9.05 score on a scale
Standard Deviation 5.46
|
10.78 score on a scale
Standard Deviation 6.58
|
9.31 score on a scale
Standard Deviation 5.49
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Relief (30 Minutes; Phase 1)
|
9.21 score on a scale
Standard Deviation 5.72
|
10.26 score on a scale
Standard Deviation 6.05
|
11.89 score on a scale
Standard Deviation 6.89
|
10.82 score on a scale
Standard Deviation 6.61
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Relief (60 Minutes; Phase 1)
|
10.38 score on a scale
Standard Deviation 6.33
|
12.29 score on a scale
Standard Deviation 7.41
|
13.05 score on a scale
Standard Deviation 7.65
|
12.06 score on a scale
Standard Deviation 6.99
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Relief (90 Minutes; Phase 1)
|
11.84 score on a scale
Standard Deviation 6.76
|
13.92 score on a scale
Standard Deviation 7.90
|
14.39 score on a scale
Standard Deviation 7.69
|
13.14 score on a scale
Standard Deviation 7.42
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Desire (Phase 2)
|
—
|
16.79 score on a scale
Standard Deviation 6.70
|
9.87 score on a scale
Standard Deviation 4.04
|
13.74 score on a scale
Standard Deviation 7.19
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Relief (Phase 2)
|
—
|
11.27 score on a scale
Standard Deviation 5.75
|
6.94 score on a scale
Standard Deviation 2.56
|
9.79 score on a scale
Standard Deviation 5.39
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Desire (Phase 3)
|
—
|
9.92 score on a scale
Standard Deviation 5.77
|
10.70 score on a scale
Standard Deviation 8.71
|
14.11 score on a scale
Standard Deviation 10.53
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Relief (Phase 3)
|
—
|
7.37 score on a scale
Standard Deviation 3.10
|
6.90 score on a scale
Standard Deviation 3.28
|
10.22 score on a scale
Standard Deviation 8.12
|
|
Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (Modified)
Desire (5 Minutes; Phase 1)
|
12.72 score on a scale
Standard Deviation 8.51
|
11.60 score on a scale
Standard Deviation 7.38
|
15.16 score on a scale
Standard Deviation 8.72
|
11.54 score on a scale
Standard Deviation 7.66
|
PRIMARY outcome
Timeframe: Phase 1-3 - Up to 3 weeksPopulation: In phases 2 and 3 only the participants' preferred product was assessed.
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.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=98 Participants
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=84 Participants
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.
|
Menthol Filtered Little Cigar (mFLC)
n=82 Participants
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.
|
Non-menthol Cigarette (nmC)
n=83 Participants
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.
|
|---|---|---|---|---|
|
Minnesota Nicotine Withdrawal Scale
MNWS (90min, Phase 1)
|
4.59 score on a scale
Standard Deviation 4.94
|
4.95 score on a scale
Standard Deviation 5.44
|
5.17 score on a scale
Standard Deviation 5.60
|
4.73 score on a scale
Standard Deviation 4.88
|
|
Minnesota Nicotine Withdrawal Scale
MNWS Craving (90min, Phase 1)
|
2.34 score on a scale
Standard Deviation 1.30
|
2.17 score on a scale
Standard Deviation 1.40
|
2.40 score on a scale
Standard Deviation 1.46
|
2.11 score on a scale
Standard Deviation 1.52
|
|
Minnesota Nicotine Withdrawal Scale
MNWS (7 day average, Phase 2)
|
—
|
12.89 score on a scale
Standard Deviation 5.55
|
7.88 score on a scale
Standard Deviation 1.06
|
12.29 score on a scale
Standard Deviation 5.13
|
|
Minnesota Nicotine Withdrawal Scale
MNWS (Post PR Task, Phase 3)
|
—
|
3.80 score on a scale
Standard Deviation 4.62
|
1.60 score on a scale
Standard Deviation 2.27
|
4.83 score on a scale
Standard Deviation 5.38
|
|
Minnesota Nicotine Withdrawal Scale
MNWS Craving (Post PR Task, Phase 3)
|
—
|
0.59 score on a scale
Standard Deviation 0.75
|
0.70 score on a scale
Standard Deviation 1.25
|
0.83 score on a scale
Standard Deviation 1.15
|
PRIMARY outcome
Timeframe: Phase 2 - 1 weekSubjective 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).
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=52 Participants
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=10 Participants
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.
|
Menthol Filtered Little Cigar (mFLC)
n=18 Participants
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.
|
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.
|
|---|---|---|---|---|
|
Subjective Effects (EMA)
Like
|
3.80 score on a scale
Standard Deviation 1.64
|
3.21 score on a scale
Standard Deviation 1.80
|
3.67 score on a scale
Standard Deviation 1.30
|
—
|
|
Subjective Effects (EMA)
Pleasurable
|
3.70 score on a scale
Standard Deviation 1.64
|
2.93 score on a scale
Standard Deviation 1.81
|
3.61 score on a scale
Standard Deviation 1.31
|
—
|
PRIMARY outcome
Timeframe: Phases 1 - Up to 2 weeksA 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.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=49 Participants
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=9 Participants
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.
|
Menthol Filtered Little Cigar (mFLC)
n=15 Participants
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.
|
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.
|
|---|---|---|---|---|
|
Cross Price Elasticity Task
|
0.315 slope
Interval 0.235 to 0.396
|
0.085 slope
Interval 0.057 to 0.114
|
0.238 slope
Interval 0.188 to 0.287
|
—
|
PRIMARY outcome
Timeframe: Phase 3 - Approximately 3 hoursA 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.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=49 Participants
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=9 Participants
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.
|
Menthol Filtered Little Cigar (mFLC)
n=15 Participants
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.
|
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.
|
|---|---|---|---|---|
|
Cross Price Elasticity Task
|
0.282 slope
Interval 0.203 to 0.36
|
0.216 slope
Interval 0.144 to 0.289
|
0.281 slope
Interval 0.182 to 0.379
|
—
|
PRIMARY outcome
Timeframe: Phase 3 - Approximately 3 hoursThe 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.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=51 Participants
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=10 Participants
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.
|
Menthol Filtered Little Cigar (mFLC)
n=18 Participants
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.
|
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.
|
|---|---|---|---|---|
|
Progressive Ratio Task (UBMC vs. Study Product)
|
5.47 Number of Puffs on UBMC
Standard Deviation 1.75
|
4.70 Number of Puffs on UBMC
Standard Deviation 2.21
|
5.06 Number of Puffs on UBMC
Standard Deviation 1.73
|
—
|
PRIMARY outcome
Timeframe: Phase 2 - 1 weekParticipants 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.
Outcome measures
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=52 Participants
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=10 Participants
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.
|
Menthol Filtered Little Cigar (mFLC)
n=18 Participants
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.
|
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.
|
|---|---|---|---|---|
|
Use Behavior (EMA)
Over 50% Substitution
|
44 Participants
|
8 Participants
|
14 Participants
|
—
|
|
Use Behavior (EMA)
Less than 50% Substitution
|
8 Participants
|
2 Participants
|
4 Participants
|
—
|
Adverse Events
Usual Brand Menthol Cigarette (UBMC)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Menthol Roll-your-own Cigarette (mRYO)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Menthol Filtered Little Cigar (mFLC)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Non-menthol Cigarette (nmC)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Usual Brand Menthol Cigarette (UBMC)
n=98 participants at risk
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.
|
Menthol Roll-your-own Cigarette (mRYO)
n=84 participants at risk
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.
|
Menthol Filtered Little Cigar (mFLC)
n=82 participants at risk
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.
|
Non-menthol Cigarette (nmC)
n=83 participants at risk
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.
|
|---|---|---|---|---|
|
Psychiatric disorders
Neurology/Mood alteration/Depression/Mild mood alteration not interfering with function
|
0.00%
0/98 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/84 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/82 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
1.2%
1/83 • Number of events 1 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Surgery/cyst removed
|
1.0%
1/98 • Number of events 1 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/84 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/82 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/83 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Smoker's Cough
|
1.0%
1/98 • Number of events 1 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/84 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/82 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/83 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
|
Psychiatric disorders
Neurology/Confusion/Transient Confusion, disorientation or attention deficit
|
1.0%
1/98 • Number of events 1 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/84 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/82 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/83 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
|
Immune system disorders
Allergy/Immunology/Autoimmune reaction/Immune System Disorders
|
1.0%
1/98 • Number of events 1 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/84 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/82 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/83 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Surgery/Intraoperative Injury/Gallbladder removed
|
0.00%
0/98 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
1.2%
1/84 • Number of events 1 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/82 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/83 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
0.00%
0/98 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/84 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
1.2%
1/82 • Number of events 1 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
0.00%
0/83 • Approximately 1 Month
No difference from clinicaltrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place