N/A
N=1,236
A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
Smoking · Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT01509586 ↗Enrolled (actual)
1,236
Serious AEs
0.5%
Results posted
Aug 2016
Primary outcome: Primary: Quit Attempts and Abstinence — 25.7; 30.8; 19.8; 25.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quit Attempts and Abstinence |
25.7; 30.8; 19.8; 25.6; 14.9; 16.2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01509586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.