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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509586
• Other study ID #: Pro00007428
• Secondary ID: R01CA154992
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: March 2016

Study information

• Verified date: July 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1236
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	From study enrollment through end of one-year follow up