Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00018161
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-07-03
Brief Title:
Treatment to Quit Smoking
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Combined PharmacologicBehavioral Treatment for Smoking Cessation
Status:
COMPLETED
Status Verified Date:
2007-09
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:
None
Brief Summary:
This protocol evaluates the efficacy of combining pharmacologic treatments for smoking cessation entailing the use of the nicotine skin patch with the nicotinic antagonist mecamylamine with a specific behavioral therapy designed to inhibit the smoking urge
Detailed Description:
Previous studies have found that nicotinemecamylamine treatment more than doubles the long-term abstinence rates relative to nicotine replacement alone Recent evidence supports the hypothesis that nicotinemecamylamine treatment prior to smoking cessation partially blocks the rewarding effects of cigarette smoking and hence promotes extinction of the smoking habit facilitating subsequent abstinence The behavioral approach employed is also an extinction strategy and involves having smokers switch to de-nicotinized tobacco cigarettes for two weeks prior to quitting smoking It is hypothesized that the use of de-nicotinized cigarettes might provide more complete extinction than provided by the partial pharmacologic blockade using nicotinemecamylamine alone The pharmacologic treatment was expected to increase compliance with the de-nicotinized cigarette smoking regimen because subjects usual brands of cigarettes will be less appealing than in the absence of nicotinemecamylamine treatment Together the brand-switching and nicotinemecamylamine therapies were expected to reduce cravings and other withdrawal symptoms as well as increase long-term abstinence from smoking
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