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Treatment to Quit Smoking

This study has been completed.
Information provided by:
VA Office of Research and Development Identifier:
First received: July 3, 2001
Last updated: January 20, 2009
Last verified: September 2007
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.

Condition Intervention Phase
Smoking Drug: Mecamylamine Drug: Nicotine Patch Behavioral: Cigarette brand switching Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Combined Pharmacologic/Behavioral Treatment for Smoking Cessation

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Study Start Date: January 1997
Estimated Study Completion Date: June 2001
Detailed Description:
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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.
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Please refer to this study by its identifier: NCT00018161

United States, North Carolina
Veterans Affairs Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
OverallOfficial: Eric C Westman, M.D.
  More Information Identifier: NCT00018161     History of Changes
Other Study ID Numbers: ADRD-008-97F
Study First Received: July 3, 2001
Last Updated: January 20, 2009

Keywords provided by VA Office of Research and Development:
cigarette smoking

Additional relevant MeSH terms:
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Ganglionic Blockers
Nicotinic Antagonists
Cholinergic Antagonists processed this record on August 23, 2017