SmokingNCT01509586
A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
A study testing Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product in people with Smoking and Smoking Cessation, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,236 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product
- Keywords
- smoking, smoking cessation, Potentially Reduced Exposure Products (PREPs)
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco productDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| PREP (Potentially Reduced Exposure Product) Group | Experimental | Not described Receives: Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product |
| cigarette group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From study enrollment through end of one-year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Matthew J. Carpenter, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509586
- Sponsor's protocol ID
- Pro00007428
- Other IDs
- R01CA154992
- Status last verified
- Jul 2023
- First submitted
- 14 Dec 2011
- Last updated
- 12 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Carpenter MJ, Wahlquist AE, Burris JL, Gray KM, Garrett-Mayer E, Cummings KM, Alberg AJ. Snus undermines quit attempts but not abstinence: a randomised clinical trial among US smokers. Tob Control. 2017 Mar;26(2):202-209. doi: 10.1136/tobaccocontrol-2015-052783. Epub 2016 Apr 12.
PubMed 27071730
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
- ClinicalTrials.gov ID
- NCT01509586
- Acronym / sponsor ID
- Pro00007428
- Conditions
- Smoking, Smoking Cessation
- Keywords
- smoking, smoking cessation, Potentially Reduced Exposure Products (PREPs)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,236 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Posted 1 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PREP (Potentially Reduced Exposure Product) Group | Experimental | Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product |
| cigarette group | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco productThe 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. | Drug | PREP (Potentially Reduced Exposure Product) Group |
Primary outcome
Quit Attempts and Abstinence
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27071730Carpenter MJ, Wahlquist AE, Burris JL, Gray KM, Garrett-Mayer E, Cummings KM, Alberg AJ. Snus undermines quit attempts but not abstinence: a randomised clinical trial among US smokers. Tob Control. 2017 Mar;26(2):202-209. doi: 10.1136/tobaccocontrol-2015-052783. Epub 2016 Apr 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J. Carpenter, Ph.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product in people with Smoking and Smoking Cessation, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quit Attempts and Abstinence (time frame: From study enrollment through end of one-year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01509586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.