An interventional study of Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product in Smoking and Smoking Cessation, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Other
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.
Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: 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.
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
| Milestone | PREP (Potentially Reduced Exposure Product) Group | Cigarette Group |
|---|---|---|
| Started | 626 | 610 |
| Week 3 | 574 | 585 |
| Week 6 | 551 | 585 |
| Week 10 | 537 | 574 |
| Week 14 | 528 | 566 |
| Week18 | 529 | 555 |
| Week 32 (month 6) | 504 | 523 |
| Week 46 | 483 | 494 |
| Week 58 (month 12) | 492 | 499 |
| Completed | 626 | 610 |
| Not completed | 0 | 0 |
% 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
| percentage of participants | PREP (Potentially Reduced Exposure Product) Group | Cigarette Group |
|---|---|---|
| Any quit attempt, ever within study | 25.7 | 30.8 |
| Any 24 h quit attempt, ever within study | 19.8 | 25.6 |
| Floating abstinence | 14.9 | 16.2 |
| Week 32 PPA | 6.2 | 5.6 |
| Week 58 PPA | 5.1 | 5.6 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PREP (Potentially Reduced Exposure Product) Group | — | 3/626 (0.5%) | 458/626 (73.2%) |
| Cigarette Group | — | 3/610 (0.5%) | 414/610 (67.9%) |
| Event | PREP (Potentially Reduced Exposure Product) Group | Cigarette Group |
|---|---|---|
| DeathGeneral disorders | 3/626 | 3/610 |
| Event | PREP (Potentially Reduced Exposure Product) Group | Cigarette Group |
|---|---|---|
| otherGeneral disorders | 338/626 | 332/610 |
| headacheGeneral disorders | 79/626 | 93/610 |
| nauseaGastrointestinal disorders | 93/626 | 82/610 |
| insomniaGeneral disorders | 66/626 | 70/610 |
| heartburnGastrointestinal disorders | 68/626 | 51/610 |
| dizziness or lightheadnednessGeneral disorders | 54/626 | 61/610 |
| burning in throat/mouthGastrointestinal disorders | 59/626 | 21/610 |
| dry mouthGeneral disorders | 53/626 | 57/610 |
| mouth sorenessGastrointestinal disorders | 46/626 | 43/610 |
| hiccupsGastrointestinal disorders | 44/626 | 21/610 |
| Age, Continuous(years) | PREP (Potentially Reduced Exposure Product) Group | Cigarette Group | Total |
|---|---|---|---|
| Mean | 48.7 ± 12.5 | 48.7 ± 12.6 | 48.7 ± 12.6 |
| Sex: Female, Male(Participants) | PREP (Potentially Reduced Exposure Product) Group | Cigarette Group | Total |
|---|---|---|---|
| Female | 438 | 397 | 835 |
| Male | 188 | 213 | 401 |
| Race/Ethnicity, Customized(participants) | PREP (Potentially Reduced Exposure Product) Group | Cigarette Group | Total |
|---|---|---|---|
| Caucasian | 557 | 531 | 1088 |
| African-American | 56 | 61 | 117 |
| Other | 13 | 18 | 31 |
| Intend to quit smoking, next month(units on a scale) | PREP (Potentially Reduced Exposure Product) Group | Cigarette Group | Total |
|---|---|---|---|
| Mean | 1.4 ± 2.3 | 1.3 ± 2.4 | 1.4 ± 2.4 |
| Confidence to quit smoking(units on a scale) | PREP (Potentially Reduced Exposure Product) Group | Cigarette Group | Total |
|---|---|---|---|
| Mean | 2.6 ± 3.1 | 2.7 ± 3.0 | 2.7 ± 3.1 |
| Cigarettes per day(average cigarettes per day at baseline) | PREP (Potentially Reduced Exposure Product) Group | Cigarette Group | Total |
|---|---|---|---|
| Mean | 20.1 ± 8.7 | 19.9 ± 8.4 | 20.0 ± 8.6 |
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina