Smoking, Smoking Cessation
Conditions
Keywords
smoking, smoking cessation, Potentially Reduced Exposure Products (PREPs)
Brief summary
This nationwide telephone and mail- based research study will recruit 1,400 cigarette smokers who are not motivated to quit to test the effects of a marketed oral, non-combustible smokeless tobacco product on cigarette smoking behaviors. It will also track the participants' usage patterns of the smokeless tobacco product. Half of the participants will receive a new, potentially safer tobacco product during the first six weeks of the study, and half will not. During this six-week period, each participant will complete three brief phone interviews. After this first six week period, participants will complete 6 other brief follow-up interviews, where they will answer questionnaires about their smoking habits.
Interventions
DRUGPotentially 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.
Sponsors
National Cancer Institute (NCI)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>=19 * a daily cigarette smoker of \>=10 cigs/day * English speaking * live in the contiguous U.S. * unmotivated to quit smoking in the next 30 days
Exclusion criteria
* no use of smokeless tobacco in past six months * not breastfeeding, pregnant, or planning a pregnancy * devoid of any recent (past 6 months) cardiovascular trauma * no quit attempt of \>=1 week in past 6 months * no use of pharmacotherapy to quit smoking in past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quit Attempts and Abstinence | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 626 |
| Cigarette Group This group will smoke their normal cigarettes as much or as little as they want to. | 610 |
| Total | 1,236 |
Baseline characteristics
| Characteristic | PREP (Potentially Reduced Exposure Product) Group | Cigarette Group | Total |
|---|---|---|---|
| Age, Continuous | 48.7 years STANDARD_DEVIATION 12.5 | 48.7 years STANDARD_DEVIATION 12.6 | 48.7 years STANDARD_DEVIATION 12.6 |
| Cigarettes per day | 20.1 average cigarettes per day at baseline STANDARD_DEVIATION 8.7 | 19.9 average cigarettes per day at baseline STANDARD_DEVIATION 8.4 | 20.0 average cigarettes per day at baseline STANDARD_DEVIATION 8.6 |
| Confidence to quit smoking | 2.6 units on a scale STANDARD_DEVIATION 3.1 | 2.7 units on a scale STANDARD_DEVIATION 3 | 2.7 units on a scale STANDARD_DEVIATION 3.1 |
| Intend to quit smoking, next month | 1.4 units on a scale STANDARD_DEVIATION 2.3 | 1.3 units on a scale STANDARD_DEVIATION 2.4 | 1.4 units on a scale STANDARD_DEVIATION 2.4 |
| Race/Ethnicity, Customized African-American | 56 participants | 61 participants | 117 participants |
| Race/Ethnicity, Customized Caucasian | 557 participants | 531 participants | 1088 participants |
| Race/Ethnicity, Customized Other | 13 participants | 18 participants | 31 participants |
| Sex: Female, Male Female | 438 Participants | 397 Participants | 835 Participants |
| Sex: Female, Male Male | 188 Participants | 213 Participants | 401 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 458 / 626 | 414 / 610 |
| serious Total, serious adverse events | 3 / 626 | 3 / 610 |
Outcome results
Primary
Quit Attempts and Abstinence
% 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
Time frame: From study enrollment through end of one-year follow up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PREP (Potentially Reduced Exposure Product) Group | Quit Attempts and Abstinence | Week 58 PPA | 5.1 percentage of participants |
| PREP (Potentially Reduced Exposure Product) Group | Quit Attempts and Abstinence | Any quit attempt, ever within study | 25.7 percentage of participants |
| PREP (Potentially Reduced Exposure Product) Group | Quit Attempts and Abstinence | Any 24 h quit attempt, ever within study | 19.8 percentage of participants |
| PREP (Potentially Reduced Exposure Product) Group | Quit Attempts and Abstinence | Floating abstinence | 14.9 percentage of participants |
| PREP (Potentially Reduced Exposure Product) Group | Quit Attempts and Abstinence | Week 32 PPA | 6.2 percentage of participants |
| Cigarette Group | Quit Attempts and Abstinence | Week 32 PPA | 5.6 percentage of participants |
| Cigarette Group | Quit Attempts and Abstinence | Floating abstinence | 16.2 percentage of participants |
| Cigarette Group | Quit Attempts and Abstinence | Any quit attempt, ever within study | 30.8 percentage of participants |
| Cigarette Group | Quit Attempts and Abstinence | Week 58 PPA | 5.6 percentage of participants |
| Cigarette Group | Quit Attempts and Abstinence | Any 24 h quit attempt, ever within study | 25.6 percentage of participants |