Trial Outcomes & Findings for Switching to Very Low Nicotine Content Cigarettes vs Reducing Cigarettes Per Day (NCT NCT03060083)
NCT ID: NCT03060083
Last Updated: 2022-10-04
Results Overview
The investigators will use non-adherence to nicotine reduction (i.e., self report of percent non-study cigarettes per day) as an indicator of feasibility.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
74 participants
Primary outcome timeframe
Assessed weekly during the 4 week reduction period after the baseline week
Results posted on
2022-10-04
Participant Flow
Participant milestones
| Measure |
Switch to VLNC Cigarettes
Participants will be instructed to use nicotine patches and gradually switch to very low nicotine content (VLNC) cigarettes throughout the study period. They will receive regular nicotine cigarettes (16.5 mg/g) during week 1, 11.26 mg/g cigarettes during week 2, 5.54 mg/g cigarettes during week 3, 2.54 mg/g cigarettes during week 4, and 0.44 mg/g cigarettes during week 5.
Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT): Participants will switch to very low nicotine content (VLNC) cigarettes with the aid of nicotine replacement therapy (NRT)
|
Reduce CPD
Participants will be instructed to use nicotine patches and gradually reduce the number of regular nicotine content cigarettes that they smoke throughout the study period. They will receive regular nicotine content cigarettes (16.5 mg/g) throughout the study study period. After establishing a baseline CPD during week 1, participants will receive 70% of their baseline CPD during week 2, 35% during week 3, 15% during week 4, and 3% during week 5. Participants will receive a minimum of 1 CPD during week 5.
Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT): Participants will reduce cigarettes per day (CPD) with the aid of nicotine replacement therapy (NRT)
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
35
|
|
Overall Study
Attended End of Baseline Study Visit
|
36
|
32
|
|
Overall Study
COMPLETED
|
31
|
27
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
Baseline characteristics by cohort
| Measure |
Switch to VLNC Cigarettes
n=36 Participants
Participants will be instructed to use nicotine patches and gradually switch to very low nicotine content (VLNC) cigarettes throughout the study period. They will receive regular nicotine cigarettes (16.5 mg/g) during week 1, 11.26 mg/g cigarettes during week 2, 5.54 mg/g cigarettes during week 3, 2.54 mg/g cigarettes during week 4, and 0.44 mg/g cigarettes during week 5.
Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT): Participants will switch to very low nicotine content (VLNC) cigarettes with the aid of nicotine replacement therapy (NRT)
|
Reduce CPD
n=32 Participants
Participants will be instructed to use nicotine patches and gradually reduce the number of regular nicotine content cigarettes that they smoke throughout the study period. They will receive regular nicotine content cigarettes (16.5 mg/g) throughout the study study period. After establishing a baseline CPD during week 1, participants will receive 70% of their baseline CPD during week 2, 35% during week 3, 15% during week 4, and 3% during week 5. Participants will receive a minimum of 1 CPD during week 5.
Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT): Participants will reduce cigarettes per day (CPD) with the aid of nicotine replacement therapy (NRT)
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.4 years
STANDARD_DEVIATION 13.4 • n=39 Participants
|
39.3 years
STANDARD_DEVIATION 13.6 • n=41 Participants
|
38.8 years
STANDARD_DEVIATION 13.4 • n=35 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
41 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White, non-Hispanic
|
28 Participants
n=39 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
28 Participants
n=41 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
56 Participants
n=35 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black, non-Hispanic
|
1 Participants
n=39 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
1 Participants
n=41 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
2 Participants
n=35 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaska Native, non-Hispanic
|
0 Participants
n=39 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
0 Participants
n=41 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
0 Participants
n=35 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian, non-Hispanic
|
0 Participants
n=39 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
0 Participants
n=41 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
0 Participants
n=35 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Pacific Islander, non-Hispanic
|
0 Participants
n=39 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
0 Participants
n=41 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
0 Participants
n=35 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Some other race
|
2 Participants
n=39 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
1 Participants
n=41 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
3 Participants
n=35 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · More than one race
|
3 Participants
n=39 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
2 Participants
n=41 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
5 Participants
n=35 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Prefer not to answer
|
2 Participants
n=39 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
0 Participants
n=41 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
2 Participants
n=35 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
0 Participants
n=39 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
0 Participants
n=41 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
0 Participants
n=35 Participants • Six participants (three in each condition) were not included in the analyses because they withdrew from the study before completing baseline or receiving their assigned intervention.
|
PRIMARY outcome
Timeframe: Assessed weekly during the 4 week reduction period after the baseline weekPopulation: Feasibility was assessed with percent non-study cigarettes. Greater percent non-study cigarettes per day indicates less feasibility. See the full paper for more detailed outcomes: https://doi.org/10.1111/add.14666
The investigators will use non-adherence to nicotine reduction (i.e., self report of percent non-study cigarettes per day) as an indicator of feasibility.
Outcome measures
| Measure |
Switch to VLNC Cigarettes
n=36 Participants
Participants will be instructed to use nicotine patches and gradually switch to very low nicotine content (VLNC) cigarettes throughout the study period. They will receive regular nicotine cigarettes (16.5 mg/g) during week 1, 11.26 mg/g cigarettes during week 2, 5.54 mg/g cigarettes during week 3, 2.54 mg/g cigarettes during week 4, and 0.44 mg/g cigarettes during week 5.
Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT): Participants will switch to very low nicotine content (VLNC) cigarettes with the aid of nicotine replacement therapy (NRT)
|
Reduce CPD
n=32 Participants
Participants will be instructed to use nicotine patches and gradually reduce the number of regular nicotine content cigarettes that they smoke throughout the study period. They will receive regular nicotine content cigarettes (16.5 mg/g) throughout the study study period. After establishing a baseline CPD during week 1, participants will receive 70% of their baseline CPD during week 2, 35% during week 3, 15% during week 4, and 3% during week 5. Participants will receive a minimum of 1 CPD during week 5.
Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT): Participants will reduce cigarettes per day (CPD) with the aid of nicotine replacement therapy (NRT)
|
|---|---|---|
|
Feasibility as Indicated by Self-reported Adherence to Study Cigarettes.
Baseline (Week 0)
|
7.1 Percent non-study cigarettes per day
Standard Error 0.03
|
7.3 Percent non-study cigarettes per day
Standard Error 0.03
|
|
Feasibility as Indicated by Self-reported Adherence to Study Cigarettes.
Week 1
|
10.4 Percent non-study cigarettes per day
Standard Error 0.03
|
13.3 Percent non-study cigarettes per day
Standard Error 0.04
|
|
Feasibility as Indicated by Self-reported Adherence to Study Cigarettes.
Week 2
|
14.8 Percent non-study cigarettes per day
Standard Error 0.05
|
31.2 Percent non-study cigarettes per day
Standard Error 0.05
|
|
Feasibility as Indicated by Self-reported Adherence to Study Cigarettes.
Week 3
|
14.1 Percent non-study cigarettes per day
Standard Error 0.05
|
52.3 Percent non-study cigarettes per day
Standard Error 0.06
|
|
Feasibility as Indicated by Self-reported Adherence to Study Cigarettes.
Week 4
|
21.4 Percent non-study cigarettes per day
Standard Error 0.06
|
72.3 Percent non-study cigarettes per day
Standard Error 0.06
|
PRIMARY outcome
Timeframe: Assessed weekly during the 4 week reduction period after the baseline weekPopulation: The NDSS overall score is reported has a t-score (range= -3.9 to 2.3) with lower scores indicating lower nicotine dependence. Please see full paper for further results: https://doi.org/10.1111/add.14666
The NDSS is a measure of dependence that does not rely on cigarettes per day as an indicator of dependence.
Outcome measures
| Measure |
Switch to VLNC Cigarettes
n=36 Participants
Participants will be instructed to use nicotine patches and gradually switch to very low nicotine content (VLNC) cigarettes throughout the study period. They will receive regular nicotine cigarettes (16.5 mg/g) during week 1, 11.26 mg/g cigarettes during week 2, 5.54 mg/g cigarettes during week 3, 2.54 mg/g cigarettes during week 4, and 0.44 mg/g cigarettes during week 5.
Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT): Participants will switch to very low nicotine content (VLNC) cigarettes with the aid of nicotine replacement therapy (NRT)
|
Reduce CPD
n=32 Participants
Participants will be instructed to use nicotine patches and gradually reduce the number of regular nicotine content cigarettes that they smoke throughout the study period. They will receive regular nicotine content cigarettes (16.5 mg/g) throughout the study study period. After establishing a baseline CPD during week 1, participants will receive 70% of their baseline CPD during week 2, 35% during week 3, 15% during week 4, and 3% during week 5. Participants will receive a minimum of 1 CPD during week 5.
Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT): Participants will reduce cigarettes per day (CPD) with the aid of nicotine replacement therapy (NRT)
|
|---|---|---|
|
Self Reported Dependence Using the Nicotine Dependence Syndrome Scale (NDSS)
Baseline (Week 0)
|
-0.7 t-score
Standard Error 0.17
|
-0.8 t-score
Standard Error 0.18
|
|
Self Reported Dependence Using the Nicotine Dependence Syndrome Scale (NDSS)
Week 1
|
-1.1 t-score
Standard Error 0.15
|
-1.0 t-score
Standard Error 0.16
|
|
Self Reported Dependence Using the Nicotine Dependence Syndrome Scale (NDSS)
Week 2
|
-1.2 t-score
Standard Error 0.17
|
-1.2 t-score
Standard Error 0.18
|
|
Self Reported Dependence Using the Nicotine Dependence Syndrome Scale (NDSS)
Week 3
|
-1.4 t-score
Standard Error 0.14
|
-1.4 t-score
Standard Error 0.15
|
|
Self Reported Dependence Using the Nicotine Dependence Syndrome Scale (NDSS)
Week 4
|
-1.7 t-score
Standard Error 0.15
|
-1.3 t-score
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Participants were asked at the end of the reduction period whether they made a quit attempt at any point during the 4 week reduction period.The percent of participants in each condition who made one or more self-reported quit attempts to stop smoking for good during the study period, lasting any length of time (including attempts lasting less than 24 hours).
Outcome measures
| Measure |
Switch to VLNC Cigarettes
n=36 Participants
Participants will be instructed to use nicotine patches and gradually switch to very low nicotine content (VLNC) cigarettes throughout the study period. They will receive regular nicotine cigarettes (16.5 mg/g) during week 1, 11.26 mg/g cigarettes during week 2, 5.54 mg/g cigarettes during week 3, 2.54 mg/g cigarettes during week 4, and 0.44 mg/g cigarettes during week 5.
Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT): Participants will switch to very low nicotine content (VLNC) cigarettes with the aid of nicotine replacement therapy (NRT)
|
Reduce CPD
n=32 Participants
Participants will be instructed to use nicotine patches and gradually reduce the number of regular nicotine content cigarettes that they smoke throughout the study period. They will receive regular nicotine content cigarettes (16.5 mg/g) throughout the study study period. After establishing a baseline CPD during week 1, participants will receive 70% of their baseline CPD during week 2, 35% during week 3, 15% during week 4, and 3% during week 5. Participants will receive a minimum of 1 CPD during week 5.
Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT): Participants will reduce cigarettes per day (CPD) with the aid of nicotine replacement therapy (NRT)
|
|---|---|---|
|
Any Quit Attempt (QA)
|
6 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Assessed at the end of the 4 week reduction periodSelf reported seven day point prevalence abstinence.
Outcome measures
| Measure |
Switch to VLNC Cigarettes
n=36 Participants
Participants will be instructed to use nicotine patches and gradually switch to very low nicotine content (VLNC) cigarettes throughout the study period. They will receive regular nicotine cigarettes (16.5 mg/g) during week 1, 11.26 mg/g cigarettes during week 2, 5.54 mg/g cigarettes during week 3, 2.54 mg/g cigarettes during week 4, and 0.44 mg/g cigarettes during week 5.
Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT): Participants will switch to very low nicotine content (VLNC) cigarettes with the aid of nicotine replacement therapy (NRT)
|
Reduce CPD
n=32 Participants
Participants will be instructed to use nicotine patches and gradually reduce the number of regular nicotine content cigarettes that they smoke throughout the study period. They will receive regular nicotine content cigarettes (16.5 mg/g) throughout the study study period. After establishing a baseline CPD during week 1, participants will receive 70% of their baseline CPD during week 2, 35% during week 3, 15% during week 4, and 3% during week 5. Participants will receive a minimum of 1 CPD during week 5.
Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT): Participants will reduce cigarettes per day (CPD) with the aid of nicotine replacement therapy (NRT)
|
|---|---|---|
|
Number of Participants With Self Reported Seven Day Point Prevalence Abstinence
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 0 - Week 4Velicer's self-efficacy scale is a self-report measure of self-efficacy to quit smoking (1=least to 5=most).
Outcome measures
| Measure |
Switch to VLNC Cigarettes
n=36 Participants
Participants will be instructed to use nicotine patches and gradually switch to very low nicotine content (VLNC) cigarettes throughout the study period. They will receive regular nicotine cigarettes (16.5 mg/g) during week 1, 11.26 mg/g cigarettes during week 2, 5.54 mg/g cigarettes during week 3, 2.54 mg/g cigarettes during week 4, and 0.44 mg/g cigarettes during week 5.
Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT): Participants will switch to very low nicotine content (VLNC) cigarettes with the aid of nicotine replacement therapy (NRT)
|
Reduce CPD
n=32 Participants
Participants will be instructed to use nicotine patches and gradually reduce the number of regular nicotine content cigarettes that they smoke throughout the study period. They will receive regular nicotine content cigarettes (16.5 mg/g) throughout the study study period. After establishing a baseline CPD during week 1, participants will receive 70% of their baseline CPD during week 2, 35% during week 3, 15% during week 4, and 3% during week 5. Participants will receive a minimum of 1 CPD during week 5.
Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT): Participants will reduce cigarettes per day (CPD) with the aid of nicotine replacement therapy (NRT)
|
|---|---|---|
|
Self-efficacy to Quit Smoking
Baseline (Week 0)
|
2.5 units on a scale
Standard Error 0.16
|
2.9 units on a scale
Standard Error 0.17
|
|
Self-efficacy to Quit Smoking
Week 1
|
2.6 units on a scale
Standard Error 0.17
|
2.7 units on a scale
Standard Error 0.18
|
|
Self-efficacy to Quit Smoking
Week 2
|
2.7 units on a scale
Standard Error 0.17
|
2.8 units on a scale
Standard Error 0.18
|
|
Self-efficacy to Quit Smoking
Week 3
|
3.1 units on a scale
Standard Error 0.17
|
2.8 units on a scale
Standard Error 0.19
|
|
Self-efficacy to Quit Smoking
Week 4
|
3.4 units on a scale
Standard Error 0.18
|
2.6 units on a scale
Standard Error 0.19
|
Adverse Events
Switch to VLNC Cigarettes
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Reduce CPD
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Switch to VLNC Cigarettes
n=36 participants at risk
Participants will be instructed to use nicotine patches and gradually switch to very low nicotine content (VLNC) cigarettes throughout the study period. They will receive regular nicotine cigarettes (16.5 mg/g) during week 1, 11.26 mg/g cigarettes during week 2, 5.54 mg/g cigarettes during week 3, 2.54 mg/g cigarettes during week 4, and 0.44 mg/g cigarettes during week 5.
Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT): Participants will switch to very low nicotine content (VLNC) cigarettes with the aid of nicotine replacement therapy (NRT)
|
Reduce CPD
n=32 participants at risk
Participants will be instructed to use nicotine patches and gradually reduce the number of regular nicotine content cigarettes that they smoke throughout the study period. They will receive regular nicotine content cigarettes (16.5 mg/g) throughout the study study period. After establishing a baseline CPD during week 1, participants will receive 70% of their baseline CPD during week 2, 35% during week 3, 15% during week 4, and 3% during week 5. Participants will receive a minimum of 1 CPD during week 5.
Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT): Participants will reduce cigarettes per day (CPD) with the aid of nicotine replacement therapy (NRT)
|
|---|---|---|
|
General disorders
Mild chest pain/tightness
|
0.00%
0/36 • 5 weeks
|
6.2%
2/32 • Number of events 2 • 5 weeks
|
|
Musculoskeletal and connective tissue disorders
Mild muscle ache/spasm
|
5.6%
2/36 • Number of events 3 • 5 weeks
|
12.5%
4/32 • Number of events 5 • 5 weeks
|
|
Investigations
Headache/Dizziness
|
8.3%
3/36 • Number of events 4 • 5 weeks
|
6.2%
2/32 • Number of events 3 • 5 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough/Mucus
|
13.9%
5/36 • Number of events 5 • 5 weeks
|
3.1%
1/32 • Number of events 1 • 5 weeks
|
|
Investigations
Heart palpitation
|
2.8%
1/36 • Number of events 2 • 5 weeks
|
3.1%
1/32 • Number of events 1 • 5 weeks
|
|
Investigations
Disrupted sleep
|
5.6%
2/36 • Number of events 3 • 5 weeks
|
9.4%
3/32 • Number of events 4 • 5 weeks
|
|
Psychiatric disorders
Mood
|
8.3%
3/36 • Number of events 4 • 5 weeks
|
12.5%
4/32 • Number of events 5 • 5 weeks
|
|
Gastrointestinal disorders
Nausea
|
5.6%
2/36 • Number of events 2 • 5 weeks
|
12.5%
4/32 • Number of events 4 • 5 weeks
|
|
Skin and subcutaneous tissue disorders
Mouth irritation/dryness
|
5.6%
2/36 • Number of events 3 • 5 weeks
|
0.00%
0/32 • 5 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
16.7%
6/36 • Number of events 7 • 5 weeks
|
6.2%
2/32 • Number of events 4 • 5 weeks
|
|
Investigations
Other
|
11.1%
4/36 • Number of events 4 • 5 weeks
|
6.2%
2/32 • Number of events 4 • 5 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place