Primary Outcome Measures:
- Percent reduction in use [ Time Frame: Week 8, 12, and 26 ] [ Designated as safety issue: No ]
- Toxicity profile of carcinogen metabolites [ Time Frame: Week 8, 12, and 26 ] [ Designated as safety issue: No ]
- Number of unsuccessful quit attempts [ Time Frame: Week 8, 12, and 26 ] [ Designated as safety issue: No ]
- Abstinence (measured at Weeks 8, 12, and 26) [ Time Frame: Week 8, 12, and 26 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Motivation and self-efficacy (measured at Weeks 8, 12, and 26) [ Time Frame: Week 8, 12, and 26 ] [ Designated as safety issue: No ]
Spit tobacco presents as many health risks to its users as smoking tobacco. Although a significant number of ST users recognize the importance of quitting, many either do not want to quit or feel it is impossible. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. However, approaches to help ST users reach this goal have not been studied. This study will assess the effectiveness of using tobacco-free snuff in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.
Participants will be randomly assigned to receive either treatment with tobacco-free snuff or treatment without it. All participants will be encouraged to reduce nicotine intake by 50% during the first four weeks and by 75% the following four weeks. Participants receiving the tobacco-free snuff will be asked to alternate the use of their usual brand of ST with tobacco-free snuff in order to achieve the targeted reduction. Participants not receiving the tobacco-free snuff will only be informed to try to cut down their tobacco use to the targeted reduction. Study visits will occur once weekly during the 8-week treatment period. Assessments will include vital signs, physiological measures related to tobacco use, and measures of motivation and self-efficacy to quit ST. The number of participants who either do not complete treatment, reduce nicotine intake, or quit completely will be assessed at the Week 8 study visit and at follow-up visits, which will be held at Weeks 12 and 26.