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Treatment to Quit Smoking
This study has been completed.
Study NCT00018161   Information provided by Department of Veterans Affairs
First Received: July 3, 2001   Last Updated: January 20, 2009   History of Changes

July 3, 2001
January 20, 2009
January 1997
 
 
 
Complete list of historical versions of study NCT00018161 on ClinicalTrials.gov Archive Site
 
 
 
Treatment to Quit Smoking
Combined Pharmacologic/Behavioral Treatment for Smoking Cessation

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.

Previous studies have found that nicotine/mecamylamine treatment more than doubles the long-term abstinence rates relative to nicotine replacement alone. Recent evidence supports the hypothesis that nicotine/mecamylamine 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 nicotine/mecamylamine 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 nicotine/mecamylamine treatment. Together the brand-switching and nicotine/mecamylamine therapies were expected to reduce cravings and other withdrawal symptoms as well as increase long-term abstinence from smoking.

Phase II
Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Smoking
  • Drug: Mecamylamine
  • Drug: Nicotine Patch
  • Behavioral: Cigarette brand switching
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
June 2001
 
  • Smokers,
  • Ages 18-65, wanted to quit smoking.
  • Must be in good health
  • Exclude cardiac disease, hypotensive or hypertensive, skin allergy, glaucoma, prostatic hypertrophy, pregnant women, drug or alcohol abuse, kidney disease.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00018161
 
ADRD-008-97F
Department of Veterans Affairs
 
Investigator: Eric C Westman, M.D.
Department of Veterans Affairs
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP