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

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Smoking; Smoking Cessation

Treatments: Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01509586

R01CA154992 (U.S. NIH Grant/Contract)

Pro00007428

Details and patient eligibility

About

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.

Enrollment: 1,236 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,236 participants in 2 patient groups

PREP (Potentially Reduced Exposure Product) Group

Experimental group

Treatment:

Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product

cigarette group

No Intervention group