Clinical trial NCT00218296: Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use
Official title: Treatment of Smokeless Tobacco Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Keywords: Nicotine Dependence
Tobacco Dependence
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks associated with its use. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may motivate individuals to eventually quit using tobacco. This study will compare the effectiveness of a ST reduction treatment program versus a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

Detailed description: Individuals who use ST are at increased risk for cancer or dying from cardiovascular disease. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. By participating in a tobacco reduction program, these individuals may be motivated to eventually stop using tobacco altogether. The purpose of this study is to compare a ST reduction treatment program versus a standard tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

This study will enroll regular users of ST. Participants will be randomly assigned to either a tobacco reduction program or to usual care, a standard tobacco cessation program during the first telephone contact. At the first clinic visit, participants assigned to the tobacco Reduction Group will replace their usual brand of ST with one of two options: an ST brand with less nicotine or nicotine lozenge. Participants will be encouraged to reduce their nicotine intake by at least 50% the first two weeks and encouraged to further reduce their nicotine intake in the following 4 weeks. Participants assigned to the Usual Care Group will be advised to quit and will be asked to set a quit date within two weeks. Telephone counseling, ideas on methods for sustaining cessation, and a self-help manual will also be provided along with a 2 week supply of nicotine patches. Study visits will occur at 2, 4, 8, 12, 26, and 32 (for reduction group) weeks. Outcome assessments will include vital signs, physiological measures related to tobacco use, levels of nicotine reduction, tobacco use status, and measures of motivation and self-efficacy to quit.

Eligibility criteria: Inclusion Criteria:

* No interest in stopping ST use within 90 days of study entry
* Daily use of ST in the 6 months prior to study entry

Exclusion Criteria:

* Current use of tobacco or nicotine products, other than ST
* Current unstable medical and mental health conditions
* Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use
* Pregnant or breastfeeding

Primary outcomes:
measure: Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence)
timeFrame: 12 weeks
measure: Percent Prolonged Abstinence From Tobacco at Week 12
timeFrame: 12 weeks
measure: Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence)
timeFrame: 26 week
measure: Percent Prolonged Abstinence From Tobacco at Week 26
timeFrame: 26 weeks
measure: Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence)
timeFrame: 32 Weeks
measure: Percent Prolonged Abstinence From Tobacco at Week 32
timeFrame: 32 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Univerisity of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schiller KR, Luo X, Anderson AJ, Jensen JA, Allen SS, Hatsukami DK. Comparing an immediate cessation versus reduction approach to smokeless tobacco cessation. Nicotine Tob Res. 2012 Aug;14(8):902-9. doi: 10.1093/ntr/ntr302. Epub 2012 Jan 4.