Trial Outcomes & Findings for A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco (NCT NCT01509586)
NCT ID: NCT01509586
Last Updated: 2023-07-12
Results Overview
% of study participants making a quit attempt or staying abstinent from smoking during the study Notes: Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1236 participants
Primary outcome timeframe
From study enrollment through end of one-year follow up
Results posted on
2023-07-12
Participant Flow
Participant milestones
| Measure |
PREP (Potentially Reduced Exposure Product) Group
Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
|
Cigarette Group
This group will smoke their normal cigarettes as much or as little as they want to.
|
|---|---|---|
|
Overall Study
STARTED
|
626
|
610
|
|
Overall Study
Week 3
|
574
|
585
|
|
Overall Study
Week 6
|
551
|
585
|
|
Overall Study
Week 10
|
537
|
574
|
|
Overall Study
Week 14
|
528
|
566
|
|
Overall Study
Week18
|
529
|
555
|
|
Overall Study
Week 32 (Month 6)
|
504
|
523
|
|
Overall Study
Week 46
|
483
|
494
|
|
Overall Study
Week 58 (Month 12)
|
492
|
499
|
|
Overall Study
COMPLETED
|
626
|
610
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
Baseline characteristics by cohort
| Measure |
PREP (Potentially Reduced Exposure Product) Group
n=626 Participants
Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
|
Cigarette Group
n=610 Participants
This group will smoke their normal cigarettes as much or as little as they want to.
|
Total
n=1236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 12.5 • n=93 Participants
|
48.7 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
48.7 years
STANDARD_DEVIATION 12.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
438 Participants
n=93 Participants
|
397 Participants
n=4 Participants
|
835 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
188 Participants
n=93 Participants
|
213 Participants
n=4 Participants
|
401 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
557 participants
n=93 Participants
|
531 participants
n=4 Participants
|
1088 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African-American
|
56 participants
n=93 Participants
|
61 participants
n=4 Participants
|
117 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
13 participants
n=93 Participants
|
18 participants
n=4 Participants
|
31 participants
n=27 Participants
|
|
Intend to quit smoking, next month
|
1.4 units on a scale
STANDARD_DEVIATION 2.3 • n=93 Participants
|
1.3 units on a scale
STANDARD_DEVIATION 2.4 • n=4 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 2.4 • n=27 Participants
|
|
Confidence to quit smoking
|
2.6 units on a scale
STANDARD_DEVIATION 3.1 • n=93 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 3.0 • n=4 Participants
|
2.7 units on a scale
STANDARD_DEVIATION 3.1 • n=27 Participants
|
|
Cigarettes per day
|
20.1 average cigarettes per day at baseline
STANDARD_DEVIATION 8.7 • n=93 Participants
|
19.9 average cigarettes per day at baseline
STANDARD_DEVIATION 8.4 • n=4 Participants
|
20.0 average cigarettes per day at baseline
STANDARD_DEVIATION 8.6 • n=27 Participants
|
PRIMARY outcome
Timeframe: From study enrollment through end of one-year follow up% of study participants making a quit attempt or staying abstinent from smoking during the study Notes: Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence
Outcome measures
| Measure |
PREP (Potentially Reduced Exposure Product) Group
n=626 Participants
Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
|
Cigarette Group
n=610 Participants
This group will smoke their normal cigarettes as much or as little as they want to.
|
|---|---|---|
|
Quit Attempts and Abstinence
Any quit attempt, ever within study
|
25.7 percentage of participants
|
30.8 percentage of participants
|
|
Quit Attempts and Abstinence
Any 24 h quit attempt, ever within study
|
19.8 percentage of participants
|
25.6 percentage of participants
|
|
Quit Attempts and Abstinence
Floating abstinence
|
14.9 percentage of participants
|
16.2 percentage of participants
|
|
Quit Attempts and Abstinence
Week 32 PPA
|
6.2 percentage of participants
|
5.6 percentage of participants
|
|
Quit Attempts and Abstinence
Week 58 PPA
|
5.1 percentage of participants
|
5.6 percentage of participants
|
Adverse Events
PREP (Potentially Reduced Exposure Product) Group
Serious events: 3 serious events
Other events: 458 other events
Deaths: 0 deaths
Cigarette Group
Serious events: 3 serious events
Other events: 414 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PREP (Potentially Reduced Exposure Product) Group
n=626 participants at risk
Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
|
Cigarette Group
n=610 participants at risk
This group will smoke their normal cigarettes as much or as little as they want to.
|
|---|---|---|
|
General disorders
Death
|
0.48%
3/626 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
0.49%
3/610 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
Other adverse events
| Measure |
PREP (Potentially Reduced Exposure Product) Group
n=626 participants at risk
Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
|
Cigarette Group
n=610 participants at risk
This group will smoke their normal cigarettes as much or as little as they want to.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
14.9%
93/626 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
13.4%
82/610 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
|
General disorders
headache
|
12.6%
79/626 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
15.2%
93/610 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
|
Gastrointestinal disorders
heartburn
|
10.9%
68/626 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
8.4%
51/610 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
|
Gastrointestinal disorders
mouth soreness
|
7.3%
46/626 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
7.0%
43/610 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
|
General disorders
dizziness or lightheadnedness
|
8.6%
54/626 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
10.0%
61/610 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
|
General disorders
dry mouth
|
8.5%
53/626 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
9.3%
57/610 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
|
General disorders
sore jaw
|
2.2%
14/626 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
3.0%
18/610 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
|
General disorders
excessive salivation
|
4.6%
29/626 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
2.5%
15/610 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
|
General disorders
insomnia
|
10.5%
66/626 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
11.5%
70/610 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
|
Gastrointestinal disorders
hiccups
|
7.0%
44/626 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
3.4%
21/610 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
|
Gastrointestinal disorders
burning in throat/mouth
|
9.4%
59/626 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
3.4%
21/610 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
|
General disorders
other
|
54.0%
338/626 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
54.4%
332/610 • Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
|
Additional Information
Dr. Matthew J. Carpenter
Medical University of South Carolina
Phone: 843-876-2436
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place