Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use
|Tobacco Use Disorder||Drug: Usual Care Group Other: Reduction Group||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Smokeless Tobacco Users|
- Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence) [ Time Frame: 12 weeks ]No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)
- Percent Prolonged Abstinence From Tobacco at Week 12 [ Time Frame: 12 weeks ]Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)
- Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence) [ Time Frame: 26 week ]Abstinence from tobacco 7 days prior to Week 26 (Assessed 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date)
- Percent Prolonged Abstinence From Tobacco at Week 26 [ Time Frame: 26 weeks ]Continuous Abstinence from quit date through Week 26 (Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).
- Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence) [ Time Frame: 32 Weeks ]Abstinence from tobacco 7 days prior to Week 26 (Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care).
- Percent Prolonged Abstinence From Tobacco at Week 32 [ Time Frame: 32 Weeks ]Continuous Abstinence from quit date through Week 32 (Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).
|Study Start Date:||November 2006|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Usual Care Group
Usual care for cessation with immediate quit date scheduled and two weeks of nicotine patch supplied.
Drug: Usual Care Group
Nicotine replacement therapy
Experimental: Reduction Group
Reduction in nicotine exposure for 6 weeks prior to quit date using medicinal nicotine lozenge or reduced nicotine smokeless tobacco.
Other: Reduction Group
Subject selects preferred method for reduction.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218296
|United States, Minnesota|
|Univerisity of Minnesota|
|Minneapolis, Minnesota, United States, 55414|
|Principal Investigator:||Dorothy Hatsukami, PhD||University of Minnesota - Clinical and Translational Science Institute|