Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use

Tobacco Use Disorder Clinical Trial

Official title:

Treatment of Smokeless Tobacco Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218296
• Other study ID #: NIDA-14404-4
• Secondary ID: R01-DA14404-4DPM
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: September 13, 2017
• Start date: November 2006
• Est. completion date: January 2009

Study information

• Verified date: September 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• Usual Care Group
Nicotine replacement therapy

Other:
• Reduction Group
Subject selects preferred method for reduction.

Locations

Country	Name	City	State
United States	Univerisity of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence)	No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)	12 weeks
Primary	Percent Prolonged Abstinence From Tobacco at Week 12	Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)	12 weeks
Primary	Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence)	Abstinence from tobacco 7 days prior to Week 26 (Assessed at 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date)	26 week
Primary	Percent Prolonged Abstinence From Tobacco at Week 26	Continuous Abstinence from quit date through Week 26 (Assessed at Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).	26 weeks
Primary	Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence)	Abstinence from tobacco 7 days prior to Week 26 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care).	32 Weeks
Primary	Percent Prolonged Abstinence From Tobacco at Week 32	Continuous Abstinence from quit date through Week 32 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).	32 Weeks

External Links

•   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.