Nicotine Lozenge to Reduce Smokeless Tobacco Use
|Tobacco Use Disorder||Drug: Nicotine Lozenge Behavioral: Behavioral Counseling||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Smokeless Tobacco Users|
- Reduction in tobacco use (measured by tobacco daily diary at Week 8, and the 12- and 26-week follow-up evaluations) [ Time Frame: 8, 12 and 26 weeks ]
- Toxicity profile of carcinogen metabolites (measured by urine screens at Week 8, and the 12- and 26-week follow-up evaluations) [ Time Frame: 8, 12 and 26 weeks ]
- Number of unsuccessful attempts to quit using tobacco (measured by tobacco use questionnaire at Week 8, and the 12- and 26-week follow-up evaluations) [ Time Frame: 8, 12 and 26 weeks ]
- Abstinence from tobacco (measured by tobacco use questionnaire at Week 8, and the 12- and 26-week follow-up evaluations) [ Time Frame: 8, 12 and 26 weeks ]
- Motivation and self-efficacy (measured by a questionnaire at Week 8, and the 12- and 26-week follow-up evaluations) [ Time Frame: 8, 12 and 26 weeks ]
|Study Start Date:||January 2005|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Experimental: 1 - Nicotine Lozenge
Use of nicotine lozenge plus behavioral counseling to help reduce tobacco use prior to quit date.
Drug: Nicotine Lozenge
Oral Nicotine replacement product
Other Name: Commite Nicotine lozenge
Placebo Comparator: 2 Behavioral counseling
Use of behavioral counseling alone to help reduce tobacco use prior to quit date.
Behavioral: Behavioral Counseling
Use of behavioral counseling to reduce tobacco use.
Individuals who use ST are at risk for developing heart disease, stroke, high blood pressure, and cancer. 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. The need exists for a program specifically aimed towards reducing, rather than quitting, tobacco use. The purpose of this study is to evaluate the effectiveness of nicotine gum at reducing ST use, as well as assessing the motivation to either quit or sustain lower levels of ST use.
This 8-week study will enroll frequent users of ST. Participants will be randomly assigned to receive either nicotine lozenge plus behavioral counseling or behavioral counseling alone. All participants will be asked to alternate use of their usual ST brand with nicotine lozenge or placebo in order to reduce nicotine intake by 50% during the first 4 weeks and by 75% the following 4 weeks. Participants will be required to maintain a daily tobacco use diary. Study visits will occur once a week. Tobacco levels will be monitored with urine tests, and questionnaires will be completed to assess tobacco use. Follow-up evaluations will occur 12 and 26 weeks following the end of treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218283
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Dorothy Hatsukami, PhD||University of Minnesota - Clinical and Translational Science Institute|