A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco

Not Applicable

Completed

• Conditions: Smoking; Smoking Cessation

• Registration Number: NCT01509586
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-14
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-13
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2016-06-20
• Results First Submitted QC: 2016-06-20
• Results First Posted: 2016-08-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States