Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218244
Status:
COMPLETED
Last Update Posted:
2017-01-10
First Post:
2005-09-16
Brief Title:
Using Smokeless Tobacco Products With Lower Nicotine Levels to Reduce Negative Effects of Smokeless Tobacco Use
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Treatment of Smokeless Tobacco Users Use of Nicotine Replacement Products to Reduce Smokeless Tobacco Use
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Brandswitch
Brief Summary:
Though spit tobacco is smokeless it still affects the cardiovascular system and may be associated with heart disease stroke and high blood pressure This study will assess the effectiveness of limiting smokeless tobacco ST nicotine intake 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
Detailed Description:
Spit tobacco presents as many health risks to its users as smoking tobacco It affects the cardiovascular system and may be associated with heart disease stroke and high blood pressure Long-term effects of spit tobacco use include tooth abrasion gum recession mouth disease bone loss in the jaw yellowing of the teeth and chronic bad breath 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 limiting ST nicotine intake 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 in this open-label study will be randomly assigned to one of three treatment conditions switching to an ST brand with less concentrated nicotine and controlling for ST use switching to an ST brand with less concentrated nicotine combined with no limit on ST intake or continued use of usual ST brand with no limit on intake control group Participants in both brand-switching conditions will use ST brands that have 50 less nicotine than their usual ST brands for the first 4 weeks For the next 4 weeks participants in the brand-switching conditions will use ST brands that have 75 less nicotine that their usual ST brands Study visits will ocur once weekly during the 8-week treatment period The number of participants who do not complete treatment reduce nicotine intake or quit completely will be assessed at Week 8 and at follow-up visits which will be held 12 and 26 weeks following the completion of treatment
Participants in this open-label study will be randomly assigned to one of three treatment conditions switching to an ST brand with less concentrated nicotine and controlling for ST use switching to an ST brand with less concentrated nicotine combined with no limit on ST intake or continued use of usual ST brand with no limit on intake control group Participants in both brand-switching conditions will use ST brands that have 50 less nicotine than their usual ST brands for the first 4 weeks For the next 4 weeks participants in the brand-switching conditions will use ST brands that have 75 less nicotine that their usual ST brands Study visits will ocur once weekly during the 8-week treatment period The number of participants who do not complete treatment reduce nicotine intake or quit completely will be assessed at Week 8 and at follow-up visits which will be held 12 and 26 weeks following the completion of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | None | None | None |
| R01-14404-1 | None | None | None |